Surgical approach to hysterectomy for benign gynaecological disease

Abstract

Background

Currently, there are five major approaches to hysterectomy for benign gynaecological disease: abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH), robotic‐assisted hysterectomy (RH) and vaginal natural orifice hysterectomy (V‐NOTES). Within the LH category we further differentiate the laparoscopic‐assisted vaginal hysterectomy (LAVH) from the total laparoscopic hysterectomy (TLH) and single‐port laparoscopic hysterectomy (SP‐LH).

Objectives

To assess the effectiveness and safety of different surgical approaches to hysterectomy for women with benign gynaecological conditions.

Search methods

We searched the following databases (from their inception to December 2022): the Cochrane Gynaecology and Fertility Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO. We also searched the trial registries and relevant reference lists, and communicated with experts in the field for any additional trials.

Selection criteria

We included randomised controlled trials (RCTs) in which clinical outcomes were compared between one surgical approach to hysterectomy and another.

Data collection and analysis

At least two review authors independently selected trials, assessed risk of bias and performed data extraction. Our primary outcomes were return to normal activities, satisfaction and quality of life, intraoperative visceral injury and major long‐term complications (i.e. fistula, pelvic‐abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition and sexual dysfunction).

Main results

We included 63 studies with 6811 women. The evidence for most comparisons was of low or moderate certainty. The main limitations were poor reporting and imprecision.

Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH) (12 RCTs, 1046 women)

Return to normal activities was probably faster in the VH group (mean difference (MD) ‐10.91 days, 95% confidence interval (CI) ‐17.95 to ‐3.87; 4 RCTs, 274 women; I² = 67%; moderate‐certainty evidence). This suggests that if the return to normal activities after AH is assumed to be 42 days, then after VH it would be between 24 and 38 days. We are uncertain whether there is a difference between the groups for the other primary outcomes.

Laparoscopic hysterectomy (LH) versus AH (28 RCTs, 3431 women)

Return to normal activities may be sooner in the LH group (MD ‐13.01 days, 95% CI ‐16.47 to ‐9.56; 7 RCTs, 618 women; I² = 68%, low‐certainty evidence), but there may be more urinary tract injuries in the LH group (odds ratio (OR) 2.16, 95% CI 1.19 to 3.93; 18 RCTs, 2594 women; I² = 0%; moderate‐certainty evidence). This suggests that if the return to normal activities after abdominal hysterectomy is assumed to be 37 days, then after laparoscopic hysterectomy it would be between 22 and 25 days. It also suggests that if the rate of ureter injury during abdominal hysterectomy is assumed to be 0.2%, then during laparoscopic hysterectomy it would be between 0.2% and 2%. We are uncertain whether there is a difference between the groups for the other primary outcomes.

LH versus VH (22 RCTs, 2135 women)

We are uncertain whether there is a difference between the groups for any of our primary outcomes. Both short‐ and long‐term complications were rare in both groups.

Robotic‐assisted hysterectomy (RH) versus LH (three RCTs, 296 women)

None of the studies reported satisfaction rates or quality of life. We are uncertain whether there is a difference between the groups for our other primary outcomes.

Single‐port laparoscopic hysterectomy (SP‐LH) versus LH (seven RCTs, 621 women)

None of the studies reported satisfaction rates, quality of life or major long‐term complications. We are uncertain whether there is a difference between the groups for rates of intraoperative visceral injury.

Total laparoscopic hysterectomy (TLH) versus laparoscopic‐assisted vaginal hysterectomy (LAVH) (three RCTs, 233 women)

None of the studies reported satisfaction rates or quality of life. We are uncertain whether there is a difference between the groups for rates of intraoperative visceral injury or major long‐term complications.

Transvaginal natural orifice transluminal endoscopic surgery (V‐NOTES) versus LH (two RCTs, 96 women)

We are uncertain whether there is a difference between the groups for rates of bladder injury. Our other primary outcomes were not reported.

Overall, adverse events were rare in the included studies.

Authors' conclusions

Among women undergoing hysterectomy for benign disease, VH appears to be superior to AH. When technically feasible, VH should be performed in preference to AH because it is associated with faster return to normal activities, fewer wound/abdominal wall infections and shorter hospital stay. Where VH is not possible, LH has advantages over AH including faster return to normal activities, shorter hospital stay, and decreased risk of wound/abdominal wall infection, febrile episodes or unspecified infection, and transfusion. These advantages must be balanced against the increased risk of ureteric injury and longer operative time. When compared to LH, VH was associated with no difference in time to return to normal activities but shorter operative time and shorter hospital stay. RH and V‐NOTES require further evaluation since there is a lack of evidence of any patient benefit over conventional LH. Overall, the evidence in this review has to be interpreted with caution as adverse event rates were low, resulting in low power for these comparisons. The surgical approach to hysterectomy should be discussed with the patient and decided in the light of the relative benefits and hazards. Surgical expertise is difficult to quantify and poorly reported in the available studies and this may influence outcomes in ways that cannot be accounted for in this review. In conclusion, when VH is not feasible, LH has multiple advantages over AH, but at the cost of more ureteric injuries. Evidence is limited for RH and V‐NOTES.

Plain language summary

Surgical approach to hysterectomy for benign gynaecological diseases

Review question

We evaluated which is the most effective and safe surgery for hysterectomy in women with benign gynaecological disease.

Background

Hysterectomy for benign gynaecological disease, mostly abnormal uterine bleeding, prolapse or uterine fibroids, is one of the most frequent gynaecological procedures (30% of women by the age of 60; 590,000 procedures annually in the USA). It can be performed through several approaches. Abdominal hysterectomy involves removal of the uterus through an incision in the lower abdomen. Vaginal hysterectomy involves removal of the uterus via the vagina, without an abdominal incision. Laparoscopic hysterectomy involves 'keyhole surgery' through small incisions in the abdomen. The uterus may be removed vaginally or, after morcellation (cutting it up), through one of the small incisions. There are various types of laparoscopic hysterectomy, depending on the extent of the surgery performed laparoscopically compared to that performed vaginally. More recently, laparoscopic hysterectomy has been performed robotically. In robotic surgery, the operation is done by a robot, while the (human) surgeon steers the robot from a chair in the corner of the operating room. Even more recently, laparoscopic instruments have been used through incisions in the vagina to perform hysterectomy (vaginal natural orifice hysterectomy or V‐NOTES). It is important to be well‐informed about the relative benefits and harms of each approach to make the best informed choices for each woman needing hysterectomy for benign disease.

Study characteristics

We analysed 63 randomised controlled trials (RCTs). An RCT is a type of study in which the people being studied are randomly allocated one or other of the different treatments being investigated. This type of study is usually the best way to evaluate whether a treatment is truly effective, i.e. truly helps the patient. A systematic review systematically summarises the available RCTs on a subject.

A total of 6811 women participated in the studies. The studies compared vaginal versus abdominal hysterectomy (12 trials, 1046 women), laparoscopic versus abdominal hysterectomy (28 trials, 3431 women), laparoscopic versus vaginal hysterectomy (22 trials, 2135 women), laparoscopic versus robot‐assisted hysterectomy (three trials, 296 women) and laparoscopic versus transvaginal natural orifice transluminal endoscopic surgery (two trials, 96 women). There were also studies included in which different types of laparoscopic hysterectomies were compared, including single‐port versus multi‐port (seven trials, 613 women) and total laparoscopic hysterectomy versus laparoscopic‐assisted vaginal hysterectomy (three trials, 233 women). The main outcomes were return to normal activities, satisfaction, quality of life and surgical complications.

Key results

We found that vaginal hysterectomy probably results in a quicker return to normal activities than abdominal hysterectomy. If the return to normal activities after abdominal hysterectomy is assumed to be 42 days, then after vaginal hysterectomy it would be between 24 and 38 days. We are uncertain whether there is a difference between the groups for the other main outcomes. However, non‐numerical data may suggest improved quality of life after vaginal hysterectomy compared to abdominal hysterectomy.

Laparoscopic hysterectomy also probably results in a quicker return to normal activities than abdominal hysterectomy. Based on our findings, if the return to normal activities after abdominal hysterectomy is assumed to be 37 days, after laparoscopic hysterectomy it would be between 22 and 25 days. However, laparoscopic hysterectomies are likely associated with greater risk of damaging the ureter (tube that carries urine from the kidney to the bladder). If the rate of ureter injury during abdominal hysterectomy is assumed to be 0%, then during laparoscopic hysterectomy it would be between 0% and 2%. We are uncertain whether there is a difference between laparoscopic and vaginal hysterectomy, between laparoscopic and robot‐assisted hysterectomy, or between laparoscopic and natural orifice surgery for our main outcomes. Many studies did not include information about patient satisfaction or quality of life.

We conclude that vaginal hysterectomy should be performed whenever possible. Where vaginal hysterectomy is not possible, the laparoscopic approach has advantages over abdominal hysterectomy but greater risk of ureter injury. These pros and cons should be incorporated in the decision‐making process with the patient.

The evidence is current to December 2022.

Certainty of the evidence

We had low or moderate confidence in the evidence for most of the comparisons. The main limitations were poor reporting of study methods and the evidence being based on few cases of the condition/type of event.

Summary of findings

Summary of findings 1. Vaginal hysterectomy versus abdominal hysterectomy for benign gynaecological disease.

Vaginal hysterectomy versus abdominal hysterectomy for benign gynaecological disease
Patient or population: patients with benign gynaecological disease Settings: hospital Intervention: vaginal versus abdominal hysterectomy
Outcomes		Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
		Risk with abdominal hysterectomy	Risk with vaginal hysterectomy
Return to normal activities (days)		The mean return to normal activities (days) in the AH group was 42.1days	The mean return to normal activities (days) in the VH group was 10.91 lower (17.95 to 3.87 lower)	—	274 (4 RCTs)	⊕⊕⊕◯ Moderate1	—
Long‐term outcomes	Satisfaction (dichotomous)	915 per 1000	967 per 1000 (844 to 994)	OR 2.69 (0.50 to 14.42)	119 (1 RCT)	⊕◯◯◯ Very low2,3,4	—
	Quality of life (descriptive data)	No study in this comparison reported on quality of life
Long‐term complications (dichotomous)	Urinary dysfunction	11 per 1000	35 per 1000 (4 to 266)	OR 3.20 (0.32 to 31.90)	177 (2 RCTs)	⊕⊕◯◯ Low5,6	—
Intra‐operative visceral injury (dichotomous)	Bladder injury	6 per 1000	9 per 1000 (3 to 28)	OR 1.62 (0.52 to 4.99)	697 (7 RCTs)	⊕⊕◯◯ Low5,6	—
	Ureter injury	0 per 1000	0 per 1000 (0 to 0)	OR 3.10 (0.12 to 79.23)	277 (3 RCTs)	⊕◯◯◯ Very low7,8	—
Major short‐term complications (dichotomous)	Vaginal cuff infection	9 per 1000	29 per 1000 (4 to 161)	OR 3.14 (0.48 to 20.55)	216 (3 RCTs)	⊕⊕◯◯ Low9,10	—
	Wound/abdominal wall infection	61 per 1000	11 per 1000 (4 to 33)	OR 0.18 (0.06 to 0.53)	628 (6 RCTs)	⊕⊕⊕◯ Moderate9	—
	Febrile episodes or unspecified infection	132 per 1000	82 per 1000 (50 to 133)	OR 0.59 (0.35 to 1.01)	593 (6 RCTs)	⊕⊕⊕◯ Moderate11	—
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). AH: abdominal hysterectomy; CI: confidence interval; MD: mean difference; OR: odds ratio; RCT: randomised controlled trial; VH: vaginal hysterectomy
GRADE Working Group grades of evidence High certainty: Further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: We are very uncertain about the estimate.

¹Downgraded one level for inconsistency: the I² statistic is high (67%), with minimal overlap in confidence intervals, however most studies favour the vaginal approach. 
²Downgraded one level for risk of bias: the study involved had unclear allocation concealment, no blinding and unclear selective reporting bias. 
³Downgraded two levels for indirectness: a single study cannot be held to represent all possible populations having this surgery.
⁴Downgraded one level for imprecision: the result comes from a single study (Benassi 2002, n = 119) and has a wide confidence interval that crosses the line of no effect. 
⁵Downgraded one level for risk of bias: sources of bias included unclear randomisation, allocation concealment, reporting bias etc.
⁶Downgraded one level for imprecision: the studies included are small and the outcome is rare; the total number of events is insufficient. 
⁷Downgraded one level for risk of bias: one study had unclear allocation concealment; others lacked details on surgeon experience or methods. 
⁸Downgraded two levels for imprecision: only three studies reported on this outcome and only one contributed data to the meta‐analysis, thus the optimal information size for a rare outcome like this one was not reached. 
⁹Downgraded one level for risk of bias: some studies lacked clear randomisation and allocation processes. 
¹⁰Downgraded one level for imprecision: only three studies reported on this rare outcome.
¹¹Downgraded one level for risk of bias: one study had unclear randomisation, another had unclear allocation concealment, multiple others had poorly described surgical methods.

Summary of findings 2. Laparoscopic hysterectomy versus abdominal hysterectomy for benign gynaecological disease.

Laparoscopic hysterectomy versus abdominal hysterectomy for benign gynaecological disease
Patient or population: patients with benign gynaecological disease Settings: hospital Intervention: laparoscopic versus abdominal hysterectomy
Outcomes		Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
		Risk with abdominal hysterectomy	Risk with laparoscopic hysterectomy
Return to normal activities (days)		The mean return to normal activities (days) in the AH group was 36.9 days	The mean return to normal activities (days) in the LH group was 13.01 lower (16.47 to 9.56 lower)	—	618 (7 RCTs)	⨁⨁◯◯ Low1,2	—
Long‐term outcomes	Satisfaction (dichotomous)	778 per 1000	695 per 1000 (528 to 820)	OR 0.65 (0.32 to 1.30)	166 (1 RCT)	⨁◯◯◯ Very low3,4,5	Based on 1 study comparing LH (method unspecified) versus AH
	Quality of life (descriptive data)	Five studies in this comparison reported on quality of life. Data was obtained from several questionnaires. Three of five studies found that quality of life improved postoperatively independent of route of surgery but was overall higher in the LH group than in the AH group. Two studies found no significant differences in postoperative quality of life between the LH and AH groups.
Long‐term complications (dichotomous)	Urinary dysfunction	135 per 1000	128 per 1000 (71 to 222)	OR 0.94 (0.49 to 1.82)	343 (3 RCTs)	⨁⨁◯◯ Low7,9	—
Intra‐operative visceral injury (dichotomous)	Bladder injury	10 per 1000	17 per 1000 (9 to 31)	OR 1.68 (0.88 to 3.22)	2298 (15 RCTs)	⨁⨁◯◯ Low6,7	—
	Ureter injury	1 per 1000	5 per 1000 (2 to 16)	OR 3.62 (1.18 to 11.11)	1675 (10 RCTs)	⨁⨁⨁◯ Moderate8	—
Major short‐term complications (dichotomous)	Vaginal cuff infection	24 per 1000	34 per 1000 (16 to 69)	OR 1.43 (0.67 to 3.04)	852 (9 RCTs)	⨁⨁◯◯ Low7,9	—
	Wound/abdominal wall infection	81 per 1000	18 per 1000 (9 to 38)	OR 0.21 (0.10 to 0.45)	824 (9 RCTs)	⨁⨁⨁◯ Moderate10	—
	Febrile episodes or unspecified infection	124 per 1000	84 per 1000 (65 to 107)	OR 0.65 (0.49 to 0.85)	2386 (18 RCTs)	⨁⨁⨁◯ Moderate11	—
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). AH: abdominal hysterectomy; CI: confidence interval; LH: laparoscopic hysterectomy; MD: mean difference; OR: odds ratio; RCT: randomised controlled trial
GRADE Working Group grades of evidence High certainty: Further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: We are very uncertain about the estimate.

¹Downgraded one level for risk of bias: multiple studies had unclear risk of bias in other important areas such as randomisation, allocation concealment, attrition bias and selective reporting bias. Other sources of bias included poor reporting on surgical methods or surgeon experience (Ekanayake 2020), and lack of power calculation (Summitt 1992). 
²Downgraded one level for inconsistency: heterogeneity as measured by the I² statistic is high (68%), however all but one study consistently favoured LH.
³Downgraded one level for risk of bias: the study involved had no blinding, high risk of attrition bias and unclear reporting bias. 
⁴Downgraded two levels for indirectness: a single study cannot be held to represent all possible populations having this surgery. 
⁵Downgraded one level for imprecision: the study involved was small, with a wide confidence interval. 
⁶Downgraded one level for risk of bias: while it was felt unlikely lack of blinding would affect this outcome, most studies had other important sources of potential bias. These included unclear randomisation and allocation concealment, high risk of attrition bias (Garry 2004; Kluivers 2007; Lumsden 2000; Wakhloo 2015), selective reporting bias (Wakhloo 2015), and other sources of bias such as poor reporting of surgical methods. 
⁷Downgraded one level for imprecision: few events and CI includes appreciable benefit and harm.
⁸Downgraded one level for risk of bias: we felt it was unlikely that lack of blinding would affect this outcome, and rated it down due to other risks of bias. For example Wakhloo 2015 and Perino 1999 both had unclear randomisation and allocation concealment. Multiple studies had poorly reported surgical methods. While it is less clear if it would specifically alter this outcome, Kluivers 2007, Garry 2004 and Lumsden 2000 had high risk of attrition bias. 
⁹Downgraded one level for risk of bias: there were significant sources of bias in the included studies that we felt lowered the certainty of evidence for this outcome. These included multiple studies with unclear allocation concealment, attrition bias, lack of intention‐to‐treat analysis, unclear length of follow‐up etc. 
¹⁰Downgraded one level for risk of bias: some of the studies that contributed most to the meta‐analysis (for example, Wakhloo 2015 and Panda 2015) were very poorly reported with high risk of randomisation, allocation concealment and attrition bias. 
¹¹Downgraded one level for risk of bias: multiple studies had unclear randomisation and allocation concealment. There were multiple concerns about attrition bias, reporting bias, lack of intention‐to‐treat analysis and poorly reported surgical methods.

Summary of findings 3. Laparoscopic hysterectomy versus vaginal hysterectomy for benign gynaecological disease.

Laparoscopic hysterectomy versus vaginal hysterectomy for benign gynaecological disease
Patient or population: patients with benign gynaecological disease Settings: hospital Intervention: laparoscopic versus vaginal hysterectomy
Outcomes		Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
		Risk with vaginal hysterectomy	Risk with laparoscopic hysterectomy
Return to normal activities (days)		The mean return to normal activities (days) in the VH group was 30.7 days	The mean return to normal activities (days) in the LH group was 1.06 lower (4.18 lower to 2.05 higher)	—	238 (3 RCTs)	⨁⨁◯◯ Low1	—
Long‐term outcomes	Satisfaction (dichotomous)	No study in this comparison reported on satisfaction.
	Quality of life (descriptive data)	One study in this comparison reported on quality of life. Data was obtained using a quality of life questionnaire. No significant difference was found between the LH and VH group. The quality of life scores were higher for both the TLH and NDVH groups than for the LAVH group.
Long‐term complications (dichotomous)	Urinary dysfunction	24 per 1000	24 per 1000 (6 to 92)	OR 1.00 (0.25 to 4.07)	248 (3 RCTs)	⨁⨁◯◯ Low1,3	—
Intra‐operative visceral injury (dichotomous)	Bladder injury	13 per 1000	13 per 1000 (5 to 31)	OR 0.93 (0.37 to 2.33)	1237 (10 RCTs)	⨁⨁◯◯ Low1,3	—
	Ureter injury	3 per 1000	2 per 1000 (0 to 16)	OR 0.69 (0.09 to 5.43)	846 (4 RCTs)	⨁⨁◯◯ Low1,2	—
Major short‐term complications (dichotomous)	Vaginal cuff infection	22 per 1000	21 per 1000 (5 to 89)	OR 0.98 (0.22 to 4.39)	276 (4 RCTs)	⨁⨁◯◯ Low1,4	—
	Wound/abdominal wall infection	6 per 1000	8 per 1000 (2 to 40)	OR 1.41 (0.28 to 7.03)	363 (4 RCTs)	⨁◯◯◯ Very low1,5	—
	Febrile episodes or unspecified infection	60 per 1000	49 per 1000 (32 to 73)	OR 0.81 (0.53 to 1.24)	1508 (12 RCTs)	⨁⨁◯◯ Low3,6	—
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LH: laparoscopic hysterectomy; LAVH: laparoscopically‐assisted vaginal hysterectomy; MD: mean difference; NDVH: non‐descent vaginal hysterectomy; OR: odds ratio; RCT: randomised controlled trial; TLH: total laparoscopic hysterectomy; VH: vaginal hysterectomy
GRADE Working Group grades of evidence High certainty: Further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: We are very uncertain about the estimate.

¹Downgraded two levels for imprecision: the studies involved were small. The confidence interval is wide and includes the possibility of treatment benefit or harm. 
²Downgraded one level for risk of bias: Allam 2015 and Garry 2004 were the main studies contributing to the meta‐analysis. We did not feel the risk of bias in Allam would impact this outcome. However, in Garry 2004 the number of patients who dropped out prior to surgery was high (n = 17). In the LH arm the loss to follow‐up was high (> 15%). Surgeon experience varied and surgical methods were not reported. 
³Downgraded one level for risk of bias: while the lack of blinding across studies was felt unlikely to contribute bias to this outcome, multiple studies had unclear randomisation, allocation concealment, risk of attrition bias and poorly reported surgical methods.
⁴Downgraded one level for risk of bias: two studies had unclear allocation concealment (Darai 2001; Summitt 1992). Additionally, Summitt 1992 contributed the most to the meta‐analysis and had two different groups of surgeons performing the procedures. 
⁵Downgraded one level for risk of bias: multiple studies involved had poorly reported methods with unclear randomisation, allocation concealment and attrition bias. 
⁶Downgraded one level for imprecision: the studies involved are small; the confidence interval includes the possibility of treatment benefit or harm.

Summary of findings 4. Robotic hysterectomy compared to laparoscopic hysterectomy for benign gynaecological disease.

Robotic hysterectomy versus laparoscopic hysterectomy for benign gynaecological disease
Patient or population: patients with benign gynaecological disease Settings: hospital Intervention: robotic versus laparoscopic hysterectomy
Outcomes		Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
		Risk with laparoscopic hysterectomy	Risk with robotic hysterectomy
Return to normal activities (days)		The mean return to normal activities (days) in the LH group was 31.2 days	The mean return to normal activities (days) in the RH group was 2.4 lower (8.54 lower to 3.74 higher)	—	100 (1 RCT)	⨁◯◯◯ Very low1,2,3	Based on 1 study
Long‐term outcomes	Satisfaction (dichotomous)	No study in this comparison reported on satisfaction.
	Quality of life (descriptive data)	No study in this comparison reported on quality of life.
Long‐term complications (dichotomous)	Urinary dysfunction	No study in this comparison reported on urinary dysfunction.
Intra‐operative visceral injury (dichotomous)	Bladder injury	No study in this comparison reported on bladder injury.
	Ureter injury	20 per 1000	7 per 1000 (0 to 144)	OR 0.33 (0.01 to 8.21)	100 (1 RCT)	⨁◯◯◯ Very low2,4	—
Major short‐term complications (dichotomous)	Vaginal cuff infection	No study in this comparison reported on vaginal cuff infection.
	Wound/abdominal wall infection	16 per 1000	10 per 1000 (1 to 71)	OR 0.60 (0.08 to 4.57)	244 (2 RCTs)	⨁⨁◯◯ Low5	—
	Febrile episodes or unspecified infection	No study in this comparison reported on febrile episodes or unspecified infection.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LH: laparoscopic hysterectomy; MD: mean difference; OR: odds ratio; RCT: randomised controlled trial; RH: robotic hysterectomy
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

¹Downgraded one level for risk of bias: in the one study reporting on this outcome, allocation concealment was not described, blinding was not performed and follow‐up was not described (Sarlos 2012). 
²Downgraded two levels for indirectness: a single study cannot be held to represent all possible populations having this surgery.
³Downgraded one level for imprecision: this was a small study (50 participants per arm) and the confidence interval includes the possibility of treatment benefit or harm. 
⁴Downgraded two levels for imprecision: this was a small study (50 participants per arm) and the confidence interval includes the possibility of treatment benefit or harm. 
⁵Downgraded two levels for imprecision: the studies involved were small, the outcomes rare, and the confidence interval includes the possibility of treatment benefit or harm.

Summary of findings 5. Single‐port laparoscopic hysterectomy compared to laparoscopic hysterectomy for benign gynaecological disease.

Single‐port laparoscopic hysterectomy compared to laparoscopic hysterectomy for benign gynaecological disease
Patient or population: patients with benign gynaecological disease Settings: hospital Intervention: single‐port laparoscopic versus laparoscopic hysterectomy
Outcomes		Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
		Risk with laparoscopic hysterectomy	Risk with single‐port laparoscopic hysterectomy
Return to normal activities (days)		No study in this comparison reported on return to normal activities.
Long‐term outcomes	Satisfaction (dichotomous)	No study in this comparison reported on satisfaction.
	Quality of life (descriptive data)	No study in this comparison reported on quality of life.
Long‐term complications (dichotomous)	Urinary dysfunction	No study in this comparison reported on urinary dysfunction.
Intra‐operative visceral injury (dichotomous)	Bladder injury	0 per 1000	0 per 1000 (0 to 0)	OR 3.51 (0.14 to 89.42)	64 (1 RCT)	⨁◯◯◯ Very low1,2,3	Based on 1 study comparing SP‐LH to TLH
	Ureter injury	8 per 1000	3 per 1000 (0 to 62)	OR 0.33 (0.01 to 8.26)	251 (1 RCT)	⨁◯◯◯ Very low2,3,4	—
Major short‐term complications (dichotomous)	Vaginal cuff infection	No study in this comparison reported on vaginal cuff infection.
	Wound/abdominal wall infection	10 per 1000	10 per 1000 (2 to 48)	OR 1.03 (0.20 to 5.15)	411 (3 RCTs)	⨁⨁◯◯ Low5,6	Based on studies comparing SP‐LAVH versus LAVH
	Febrile episodes or unspecified infection	19 per 1000	47 per 1000 (13 to 153)	OR 2.56 (0.70 to 9.44)	315 (2 RCTs)	⨁◯◯◯ Very low1,4,6,7	Based on studies comparing SP‐TLH versus TLH
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LAVH: laparoscopically‐assisted vaginal hysterectomy; LH: laparoscopic hysterectomy; MD: mean difference; OR: odds ratio; RCT: randomised controlled trial; SP‐LH: single‐port laparoscopic hysterectomy; TLH: total laparoscopic hysterectomy
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

¹Downgraded one level for risk of bias: in Jung 2011 the allocation concealment was not described and four procedures that were converted from SP‐TLH to TLH were excluded from the analysis. 
²Downgraded two levels for indirectness: a single study cannot be held to represent all possible populations having this surgery.
³Downgraded one level for imprecision: this was a small study, with few events, and a confidence interval that includes the possibility of treatment benefit or harm. 
⁴Downgraded one level for risk of bias: in Kim 2015 multiple patients withdrew from the study before surgery but after randomisation. Additionally, many different surgeons were involved with varying levels of experience, the majority of whom had greater experience with conventional laparoscopy. Finally, they did not use a standardised LH technique. 
⁵Downgraded one level for risk of bias: studies involved had various potential sources of bias including unclear randomisation, allocation concealment, attrition bias, variation in surgical methods and surgeon experience. 
⁶Downgraded one level for imprecision: these were small studies, with few events, and the confidence interval includes the possibility of treatment benefit or harm.
⁷Downgraded one level for inconsistency: heterogeneity was high (I² statistic = 53%).

Summary of findings 6. Total laparoscopic hysterectomy compared to laparoscopic‐assisted vaginal hysterectomy for benign gynaecological disease.

Laparoscopic‐assisted vaginal hysterectomy versus total laparoscopic hysterectomy for benign gynaecological disease
Patient or population: patients with benign gynaecological disease Settings: hospital Intervention: laparoscopic‐assisted vaginal versus total laparoscopic hysterectomy
Outcomes		Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
		Risk with laparoscopic‐assisted vaginal hysterectomy	Risk with total laparoscopic hysterectomy
Return to normal activities (days)		No study in this comparison reported on return to normal activities.
Long‐term outcomes	Satisfaction (dichotomous)	No study in this comparison reported on satisfaction.
	Quality of life (descriptive data)	No study in this comparison reported on quality of life.
Long‐term complications (dichotomous)	Urinary dysfunction	No study in this comparison reported on urinary dysfunction.
Intra‐operative visceral injury (dichotomous)	Bladder injury	22 per 1000	16 per 1000 (1 to 158)	OR 0.72 (0.06 to 8.27)	161 (2 RCTs)	⨁⨁◯◯ Low1,2	—
	Ureter injury	11 per 1000	33 per 1000 (3 to 279)	OR 3.03 (0.27 to 34.52)	161 (2 RCTs)	⨁⨁◯◯ Low1,2	—
Major short‐term complications (dichotomous)	Vaginal cuff infection	83 per 1000	25 per 1000 (3 to 182)	OR 0.28 (0.03 to 2.45)	101 (1 RCT)	⨁◯◯◯ Very low3,4,5	—
	Abdominal wall/wound infection	67 per 1000	13 per 1000 (1 to 225)	OR 0.19 (0.01 to 4.06)	60 (1 RCT)	⨁◯◯◯ Very low4,5	—
	Febrile episodes or unspecified infection	50 per 1000	73 per 1000 (15 to 292)	OR 0.61 (0.15 to 2.45)	233 (3 RCTs)	⨁⨁◯◯ Low1,2	—
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LAVH: laparoscopic‐assisted vaginal hysterectomy; MD: mean difference; OR: odds ratio; RCT: randomised controlled trial; TLH: total laparoscopic hysterectomy
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

¹Downgraded one level for risk of bias: both studies were found to have unclear randomisation, unclear allocation concealment and high risk of attrition bias (Long 2002; Roy 2011). 
²Downgraded one level for imprecision: these were small studies with few events and the confidence interval includes the possibility of treatment benefit or harm. 
³Downgraded two levels for risk of bias: the one study involved had serious risks of bias, including unclear randomisation, allocation concealment, significant dropouts after randomisation but prior to surgery, lack of intention‐to‐treat analysis and different surgeons for different procedures (Long 2002). Combined these factors were felt by authors to merit downgrading the certainty of evidence by two levels. 
⁴Downgraded two levels for indirectness: a single study cannot be held to represent all possible populations having this surgery.
⁵Downgraded one level for imprecision: this was a small study with few events and the confidence interval includes the possibility of treatment benefit or harm. 
⁶Downgraded one level for risk of bias: Roy 2011 had unclear randomisation and allocation concealment bias as well as high risk of attrition bias.

Summary of findings 7. V‐NOTES compared to laparoscopic hysterectomy for benign gynaecological disease.

V‐NOTES versus laparoscopic hysterectomy for benign gynaecological disease
Patient or population: patients with benign gynaecological disease Settings: hospital Intervention: V‐NOTES versus laparoscopic hysterectomy
Outcomes		Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
		Risk with V‐NOTES	Risk with laparoscopic hysterectomy
Return to normal activities (days)		No study in this comparison reported on return to normal activities.
Long‐term outcomes	Satisfaction (dichotomous)	No study in this comparison reported on satisfaction.
	Quality of life (descriptive data)	No study in this comparison reported on quality of life.
Long‐term complications (dichotomous)	Urinary dysfunction	No study in this comparison reported on urinary dysfunction.
Intra‐operative visceral injury (dichotomous)	Bladder injury	0 per 1000	0 per 1000 (0 to 0)	OR 3.09 (0.12 to 78.41)	96 (2 RCTs)	⨁⨁◯◯ Low1	—
	Ureter injury	No study in this comparison reported on ureter injury.
Major short‐term complications (dichotomous)	Vaginal cuff infection	No study in this comparison reported on vaginal cuff infection.
	Wound/abdominal wall infection	0 per 1000	0 per 1000 (0 to 0)	OR 3.24 (0.12 to 87.13)	26 (1 RCT)	⨁◯◯◯ Very low1,2	Based on 1 study comparing V‐NOTES to single‐port LH
	Febrile episodes or unspecified infection	42 per 1000	42 per 1000 (7 to 207)	OR 1.00 (0.17 to 6.01)	96 (2 RCTs)	⨁⨁◯◯ Low3	—
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; LH: laparoscopic hysterectomy; MD: mean difference; OR: odds ratio; RCT: randomised controlled trial; V‐NOTES: vaginal natural orifice transluminal endoscopic surgery
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

¹Downgraded three levels for imprecision: this is from a single very small study (13 participants per arm) with few events and the confidence interval includes the possibility of treatment benefit or harm. 
²Downgraded two levels for indirectness: a single study cannot be held to represent all possible populations having this surgery.
³Downgraded two levels for imprecision: these were very small studies with few events and the confidence includes the possibility of treatment benefit or harm.

Background

Description of the condition

Hysterectomy is the surgical removal of the uterus. It is the most frequently performed major gynaecological surgical procedure, with millions of procedures performed annually throughout the world (Garry 2005; Hammer 2015). While it can be done for treatment of malignancy, approximately 90% of hysterectomies are performed for benign indications (Flory 2005; Whiteman 2008), the most common of which are fibroids, abnormal uterine bleeding, endometriosis and prolapse (Wright 2013a). The majority of these indications for surgery also have more conservative management options, such as medical management of endometriosis, uterine artery embolisation for the treatment of fibroids, endometrial ablation for abnormal uterine bleeding, or pessary for prolapse. Over the years, the number of alternative non‐surgical treatment options for each condition has increased. Despite this, many people will ultimately undergo hysterectomy. Rates of hysterectomy have declined less than expected with the introduction of new treatment modalities, perhaps because it is often seen as the only treatment offering permanent symptom relief (Pynnä 2014). The most common routes of hysterectomy have varied by region and over time (Luchristt 2021; Madhvani 2019; Whiteman 2008; Wright 2013a).

Description of the intervention

Approaches to hysterectomy may be broadly categorised into four options: abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH) and robotic‐assisted hysterectomy (RH). New to this update is the transvaginal natural orifice transluminal endoscopic surgery (V‐NOTES) route of hysterectomy.

• Abdominal hysterectomy: the abdominal hysterectomy (AH) has traditionally been the surgical approach for gynaecological malignancy, when other pelvic pathology is present such as endometriosis or adhesions, and in the context of an enlarged uterus. It remains the 'fallback option' if the uterus cannot be removed by another approach.

• Vaginal hysterectomy: vaginal hysterectomy (VH) was originally used only for prolapse but has become more widely utilised for other indications. Compared to AH, VH was (and still is) regarded as less invasive and seems to have the advantages of fewer blood transfusions, less febrile morbidity (fever) and less risk of injury to the ureter. However, the disadvantages are more bleeding complications and greater risk of bladder injury (Mäkinen 2013; Moen 2014a).

• Laparoscopic hysterectomy: laparoscopic hysterectomy (LH) refers to a hysterectomy where at least part of the operation is undertaken laparoscopically (Garry 1994). The proportion of hysterectomies performed by LH has gradually increased and, although the surgery tends to take longer, its proponents argue that the main advantages are the possibility of diagnosing and treating other pelvic diseases such as endometriosis, of carrying out adnexal surgery including the removal of the ovaries, the ability to secure thorough intraperitoneal haemostasis, and a more rapid recovery time from surgery compared to AH (Garry 1998). Multiple classifications of LH have been described (Olive 2000; Reich 1994; Richardson 1995). In this update to the review we will describe both the Richardson classification (Table 8) and the AAGL type (Table 9) of laparoscopic hysterectomy when possible. For purposes of the meta‐analysis we have simplified our subgroups of LH as follows:

  • Laparoscopic‐assisted vaginal hysterectomy (LAVH): part of the hysterectomy is performed by laparoscopic surgery and part vaginally. The vaginal component of the surgery involves more than just suturing of the vaginal cuff.

  • Total laparoscopic hysterectomy (TLH): this is where the entire operation is performed laparoscopically and there is no vaginal component except for the removal of the uterus and possibly suturing of the vaginal cuff.

  • Single‐port laparoscopic hysterectomy (SP‐LH): sometimes referred to as laparoendoscopic single site (LESS) surgery, this refers to laparoscopic hysterectomy performed through a single umbilical incision.

  • Non‐categorisable laparoscopic hysterectomy (NC‐LH): the procedure is described as laparoscopic by the authors but no further description of the surgical method is provided or various subtypes of LH are performed.

• Robotic‐assisted hysterectomy (RH): the robotic platform was approved for use in the US in 2005 and saw a rapid uptake in usage in the US and worldwide during the following years. This involves a hysterectomy approach using a robotic system, allowing more ergonomic movements that are easier to perform and are more precise in filtering tremor. One surgeon is seated in a robot console and handles the laparoscope and two to three laparoscopic instruments. RH is generally performed similarly to a TLH with suturing of the vaginal vault via the robot. Potential benefits include increased range of motion of the instruments, three‐dimensional visualisation and improved ergonomics for the surgeon (Wright 2013b). In this review RH is considered as a separate approach, which may have its own learning curve, surgical pitfalls and accompanying costs.

• Transvaginal natural orifice transluminal endoscopic surgery (V‐NOTES): first described for hysterectomy by Su et al in 2012, V‐NOTES procedures involve transvaginal peritoneal entry, establishing pneumoperitoneum and the use of multiple laparoscopic instruments placed through a vaginal port to perform the surgery (Su 2012).

1. Staging of laparoscopic hysterectomy ‐ Richardson 1995.

Stage	Laparoscopic content
0	Laparoscopy done but no laparoscopic procedure before vaginal hysterectomy
1	Procedure includes laparoscopic adhesiolysis and/or excision of endometriosis
2	Either or both adnexa freed laparoscopically
3	Bladder dissected from the uterus laparoscopically
4	Uterine artery transected laparoscopically
5	Anterior and/or posterior colpotomy or entire uterus freed laparoscopically

2. AAGL Classification System for Laparoscopic Hysterectomy.

Type O	Laparoscopic‐directed preparation for vaginal hysterectomy
Type I	Dissection up to but not including the uterine arteries
Type II	Type I + uterine artery occlusion and division, unilateral or bilateral
Type III	Type II + portion of cardinal‐uterosacral ligament complex only, unilateral or bilateral
Type IV	Type II + total cardinal‐uterosacral ligament complex, unilateral or bilateral

The first reported elective hysterectomy was performed through a vaginal approach by Conrad Langenbeck in 1813. The first elective abdominal hysterectomy, a subtotal operation (where the cervix was conserved), was performed by Charles Clay in Manchester in 1863 (Sutton 1997). These approaches remained the only two options until the latter part of the 20th century. The first laparoscopic hysterectomy (LAVH) was reported by Harry Reich in 1989 (Reich 1989). He also reported the first total laparoscopic hysterectomy (TLH) in 1993. Robotic‐assisted hysterectomies have been performed since 1998 and V‐NOTES was introduced in 2012.

Similar to the overall hysterectomy rate, the proportion of hysterectomies currently being performed by different approaches varies markedly across countries, within countries, and even between individual surgeons working within the same unit. Several patient factors may influence the surgeon's choice of approach to hysterectomy. For example, multiparous women with heavy menstrual bleeding who opt for hysterectomy may well be suitable for a vaginal approach. However, in the same case but with the suspicion of endometriosis based on dysmenorrhoea, dyspareunia, or both, the surgeon may be inclined to an abdominal or laparoscopic approach. Patient characteristics may also play a role, such as uterine descent, extra‐uterine pelvic pathology, previous pelvic surgery and obesity. Many of the historical contraindications to the vaginal approach have been disproved. For example, previous caesarean section has often been considered a contraindication for VH. However, this is not supported by cumulative data from four studies indicating no significant difference in complication rates in hysterectomy patients following caesarean section (8 of 430 (1.86%) versus 11 of 1227 (0.89%), P value = 0.12) (Agostini 2005). Around 2008, evidence emerged demonstrating that bilateral salpingectomy at the time of hysterectomy may decrease the risk of ovarian cancer, and we have seen a resulting shift in practice globally towards 'opportunistic' or 'risk‐reducing' salpingectomy since that time (Dilley 2017). However, multiple studies support the ability to safely take the fallopian tubes through a vaginal route and various guidelines recommend against making salpingectomy a deciding factor in determining the route of surgery (ACOG 2017). Additional studies support the safety of bilateral oophorectomy at the time of VH in the majority of cases (Lua 2019; Robert 2015). Multiple studies, including some in this review, specifically evaluate the vaginal and laparoscopic routes for enlarged fibroid uteri (Darai 2001; Mohammed 2017; Roy 2012; Sesti 2008b; Sesti 2014b; Soriano 2001).

How the intervention might work

This review focuses on the benefits and harms of the different surgical approaches to hysterectomy for benign indications. From the patient's perspective, quality of life may well be the most important outcome, especially in surgery for benign indications. Consequently, we have chosen patient‐reported outcome measures (PROMs) as primary outcomes. Injuries to adjacent organs are of concern in hysterectomy and their rates of occurrence differ with the various approaches to hysterectomy and surgical experience level (Brummer 2011; Mäkinen 2001; Mäkinen 2013). It is important to have adequate knowledge of the differences in adverse outcomes associated with several approaches to hysterectomy, in order to inform patients properly and to gain informed consent based on an adequate amount of data. Furthermore, operation times differ with the different approaches to hysterectomy. In general, it is presumed that the vaginal and laparoscopic approach will lead to a quicker recovery compared with open surgery, mainly because of less pain and quicker mobilisation due to smaller incisions.

In the current era of limited healthcare resources, the costs of surgery will likely play a more important role in decision‐making. Several studies have looked at the cost‐effectiveness of several types of hysterectomy (Bijen 2009; Pynnä 2014; Sarlos 2010; Tapper 2014). Overall, it is expected that VH will have the lowest costs. The cost difference between LH and AH is less clear due to the often longer hospital stay associated with AH. Due to the high purchase costs and the use of expensive disposables, RH is likely to be the least cost‐effective option. However, there is lack of well‐designed studies that also take societal costs (e.g. the costs of sick leave) into consideration.

Apart from the surgical approach, other aspects of the surgical technique for hysterectomy may have an effect on the outcome of surgery. Examples of this include total versus subtotal (where the cervix is not removed) hysterectomy (Lethaby 2012); techniques to support the vaginal vault; bilateral elective oophorectomy versus ovarian conservation (Orozco 2014); and other strategies used mainly by those conducting laparoscopic surgery with the aim of reducing the likelihood of complications, including the use of vaginal delineators, rectal probes and illuminated ureteric stents. These specific surgical techniques are not within the scope of this review (other than for assessing trial quality).

Why it is important to do this review

Since there are multiple approaches to hysterectomy, each with procedure‐specific advantages and disadvantages, it is important to know which procedure is superior with respect to patient‐related outcomes, as practice patterns can change in response to this information. Finland had a VH rate as low as 7% in the 1980s. Following annual meetings on gynaecological surgery where vaginal and laparoscopic surgery were encouraged, and individual training provided, the VH rate had increased to 44% in 2006 (Mäkinen 2013). Well‐designed RCTs of surgical interventions yield information unrivalled in its quality compared to studies of other designs. Interestingly, in 1998 there was not a single RCT comparing AH and VH (Garry 1998). The introduction of the newer approaches to hysterectomy (LH, SP‐LH and RH) has stimulated much greater interest in the scientific evaluation of all forms of hysterectomy. However, the more approaches there are, the more complex it becomes to decide on the best approach for each individual. This decision cannot be made without up‐to‐date evidence. Nor can it be made without knowing and respecting the informed preferences of patients. This review summarises the existing evidence presented in all published RCTs on benign conditions for hysterectomy. After finding and appraising the existing evidence, and integrating its inferences with clinical expertise, clinicians need to try to come to a decision that reflects their patient's values and circumstances (Hoffmann 2014). This is an update of a Cochrane Review first published in 2004, and previously updated in 2006, 2008, 2009 and 2015.

Objectives

To assess the effectiveness and safety of different surgical approaches to hysterectomy for women with benign gynaecological conditions.

Methods

Criteria for considering studies for this review

Types of studies

We included randomised controlled trials (RCTs), in which one surgical approach to hysterectomy was compared to another approach.

We excluded non‐randomised studies, as they are associated with a higher risk of bias.

Types of participants

Studies of women undergoing hysterectomy for benign disease (uterine fibroids, heavy menstrual bleeding, metrorrhagia of (suspicion of) adenomyosis etc.) were eligible for inclusion. We excluded studies of women with gynaecological cancer. When trials included both women with benign and malignant disease, we requested from the authors a breakdown of data in order to include only women with benign disease. If this information was not forthcoming, we excluded the trial.

We defined dropouts as cases in which hysterectomy was cancelled after randomisation or randomised cases were excluded from analysis by the researchers. We did not regard loss to follow‐up as dropout.

Types of interventions

Surgical approaches to removal of the uterus, where at least one approach was compared with another, were eligible for inclusion. Approaches were as follows:

• Abdominal hysterectomy (AH, including mini‐AH).

• Vaginal hysterectomy (VH).

• Laparoscopic hysterectomy, which was further subdivided into the following groups:

  • Laparoscopic‐assisted vaginal hysterectomy (LAVH).

  • Total laparoscopic hysterectomy (TLH).

  • Single‐port laparoscopic hysterectomy (SP‐LH).

  • Non‐categorisable laparoscopic hysterectomy (NC‐LH) (the procedure is described as laparoscopic by the authors but no further description of the surgical method is provided or various subtypes of LH are performed within the same arm of the trial).

• Robotic hysterectomy (RH).

• V‐NOTES hysterectomy.

We thus excluded trials comparing, for example, different vessel sealing techniques, 2D versus 3D laparoscopy or different size instruments (mini‐LH) within one approach.

Subtotal versus total hysterectomy is the scope of another Cochrane Review (Lethaby 2012); we excluded trials making this comparison from the present review. We also excluded trials evaluating different surgical approaches to subtotal hysterectomy. However, if a minority of the women (less than 33%) had a subtotal hysterectomy and the comparison was made versus any of the approaches outlined above then we included the trial.

Clinical data had to be reported in the included studies, thus excluding studies reporting only differences in laboratory results. If no relevant clinical outcomes were reported (i.e. not in the methods and results section), this was a criterion for exclusion.

Types of outcome measures

We assessed the following outcomes:

Primary outcomes

• Return to normal activities

• Satisfaction and quality of life

• Intraoperative visceral injury

  • Bladder injury

  • Ureter injury

  • Urinary tract (bladder or ureter) injury

  • Bowel injury

  • Vascular injury

• Major long‐term complications

  • Fistula

  • Pelvic‐abdominal pain

  • Urinary dysfunction

  • Bowel dysfunction

  • Pelvic floor condition (prolapse)

  • Sexual dysfunction

Secondary outcomes

• Operation time

• (Sequelae of) bleeding, including

  • Substantial bleeding

  • Transfusion

  • Pelvic haematoma

• Unintended laparotomy for approaches not involving routine laparotomy

• Short‐term outcomes and complications

  • Length of hospital stay

  • Infections

    • Vaginal cuff

    • Abdominal wall or wound

    • Urinary tract infection

    • Chest infection

    • Febrile episodes or unspecified infections

  • Thromboembolism

• Postoperative ileus

• Wound dehiscence

• Costs

We sought data on the cost of treatment, but we intended to describe these data qualitatively and not to include the information in the meta‐analysis since 'cost' could be defined differently in different studies depending upon whether studies incorporate the cost of sequelae. Different healthcare systems could produce markedly different results.

We used all types of outcome measures for meta‐analysis or described them in the review. This included composite outcome measures.

Search methods for identification of studies

We searched for all published and unpublished RCTs in December 2022, without language or date restriction and in consultation with the Cochrane Gynaecology and Fertility Information Specialist.

Electronic searches

We searched the following electronic databases:

• Cochrane Gynaecology and Fertility Specialised Register, ProCite platform, searched 1 December 2022 (Appendix 1);

• CENTRAL via the Cochrane Register of Studies Online (CRSO), Web platform, searched 1 December 2022 (Appendix 2);

• MEDLINE, Ovid platform, searched from 1946 to 1 December 2022 (Appendix 3);

• Embase, Ovid platform, searched from 1980 to 1 December 2022 (Appendix 4);

• PsycINFO, Ovid platform, searched from 1806 to 1 December 2022 (Appendix 5);

• CINAHL (Cumulative Index to Nursing and Allied Health Literature), Ebsco platform, searched from 1961 to 8 January 2020 (all later trials from CINAHL were contained in the 2022 CENTRAL output) (Appendix 6);

• Biological Abstracts, web platform, searched from 1969 to August 2008 (searches beyond 2008 were not included) (Appendix 7).

Other electronic sources of trials included:

• Trial registers for ongoing and registered trials, searched to December 2022:

  • http://www.clinicaltrials.gov (Appendix 8);

  • http://www.who.int/trialsearch/Default.aspx;

• DARE (Database of Abstracts of Reviews of Effects) on the Cochrane Library (http://onlinelibrary.wiley.com/o/cochrane/cochrane_cldare_articles_fs.html);

• Web of Knowledge (http://wokinfo.com/);

• OpenGrey (http://www.opengrey.eu/);

• LILACS (Literaturo Latino Americana e do Ciências da Saúde) database (http://regional.bvsalud.org/php/index.php?lang=en);

• PubMed; and

• Google Scholar.

We combined the MEDLINE search with the Cochrane highly sensitive search strategy for identifying randomised trials, which appears in the Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0 chapter 6, 6.4.11) (Higgins 2011).

Searching other resources

We searched the reference lists of articles retrieved by the search and contacted experts in the field to obtain additional data. We handsearched relevant journals and conference abstracts that are not covered in the Cochrane Gynaecology and Fertility Specialised Register in liaison with the Information Specialist.

Data collection and analysis

Selection of studies

Two review authors performed an initial screen of titles and abstracts retrieved by the search. We retrieved the full texts of all potentially eligible studies. Two review authors independently examined these full‐text articles for compliance with the inclusion criteria and selected studies eligible for inclusion in the review.

At least two of four review authors (ET, EC, AL, NJ) performed the selection of trials for inclusion in the initial Cochrane Review (Johnson 2005b). Two different review authors (TN and KK) performed the selection of trials for the first update in 2009 (Nieboer 2009), three review authors (JA, TN and KK) performed this for the 2015 update and four authors (JA, TB, DS, CP) for the current update.

We corresponded with study investigators as required, to clarify study eligibility. We resolved disagreements as to study eligibility by discussion or by referral to a third review author.

We documented the selection process with a PRISMA flow chart (Figure 1).

1.

Study flow diagram.

We excluded trials from the review if they made comparisons other than those specified above. A selection of these trials is detailed in the table Characteristics of excluded studies. Classically we excluded studies if they did not report on differences in clinical outcomes, but did report laboratory results or different anaesthesia techniques or sealing techniques of vessels (e.g. electrosurgical bipolar vessel sealing) in hysterectomy patients. Trials are reported in the table Characteristics of excluded studies if there are other reasons for exclusion than those mentioned above.

Data extraction and management

Two review authors (at least two review authors from ET, EC, AL, NJ, TN, JA and KK for the 2009 and 2015 updates, and JA, TB, CP and DS for the current update) independently extracted data from eligible studies using a data extraction form designed by the authors. We resolved any disagreements by discussion or by referral to a third review author. Data extracted included study characteristics and outcome data (see data extraction table for details, Appendix 9). Where studies had multiple publications we collated multiple reports of the same study, so that each study rather than each report is the unit of interest in the review, and such studies have a single study ID with multiple references. We corresponded with study investigators for further data on methods, results, or both, as required.

Assessment of risk of bias in included studies

Two review authors (at least two review authors from ET, AL, TN, JA and KK for the 2009 and 2015 updates and JA, CP, TB and DS for the current update) independently assessed the included studies for risk of bias using the Cochrane risk of bias assessment tool (Higgins 2011): selection bias (random sequence generation and allocation concealment); performance bias (blinding of participants and personnel); detection bias (blinding of outcome assessors); attrition bias (incomplete outcome data); reporting bias (selective reporting); and other bias. We resolved disagreements by discussion or by referral to a third review author. We described all judgements fully and presented the conclusions in the risk of bias tables, which we incorporated into the interpretation of the review findings by means of sensitivity analyses (see below). As per Cochrane policy, it was not required to use the new risk of bias tool (RoB 2) for updated reviews.

If randomisation and allocation concealment were not sufficiently reported, we labelled these as unclear or high risk of bias (depending on the extent of description and whether the method described was satisfactory).

If blinding was not performed or not reported, we judged this as high risk of bias.

We considered dropout rates and/or loss to follow‐up below 5% as low risk of bias. If dropouts or losses to follow‐up were not reported or were between 10% and 15%, we judged this as unclear risk of bias. If the dropouts or losses to follow‐up were substantial (i.e. more than 15%), we labelled this as high risk of bias.

If primary and/or secondary outcomes were not (pre)defined and/or a selection of outcomes was reported, we labelled this as unclear or high risk of bias.

Finally, we evaluated the studies included for any other potential bias, such as baseline data not comparable between groups or no description of surgeon experience. (Lack) of surgeon's experience could be particularly important when interpreting the results on, for instance, adverse events or operation time. This seems particularly important for the laparoscopic procedures, as studies have suggested that this technique has a specific learning curve. However, there is no clear‐cut consensus based on current evidence as to how many procedures a surgeon needs to perform (for all types of hysterectomies) to pass this learning curve. Therefore, if a study stated that a surgeon had sufficient experience (without mentioning a specific number) we did not consider this as a potential risk of bias. Depending on the extent of any other bias identified in the study, we judged this as unclear or high risk of bias. If three or more potential other biases were identified, we marked this as high risk of bias.

Measures of treatment effect

We performed statistical analysis in accordance with the guidelines in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2022). We analysed the data using an intention‐to‐treat model, where data were available.

We expressed dichotomous data as the numbers of events in the control and intervention groups of each study and calculated Mantel‐Haenszel odds ratios (OR) with 95% confidence intervals (95% CI). An increase in the odds of a particular outcome is displayed graphically in the meta‐analyses to the right of the centre line, and a decrease in the odds of an outcome is displayed graphically to the left of the centre line.

For continuous data (e.g. length of hospital stay), if all studies reported exactly the same outcomes, we calculated the mean difference (MD) between treatment groups. If similar outcomes were reported on different scales (e.g. change in haemoglobin), we calculated the standardised mean difference (SMD). We reversed the direction of effect of individual studies, if required, to ensure consistency across trials. We treated ordinal data (e.g. quality of life scores) as continuous data. We presented 95% CIs for all outcomes.

Where data to calculate ORs or MDs were not available, we utilised the most detailed numerical data available that facilitated similar analyses of included studies (e.g. test statistics, median and (interquartile) ranges, P values). We did not repeat or check values of skewness or kurtosis from the individual studies. We did not include outcome variables that were reported only graphically in the review. We compared the magnitude and direction of effect reported by studies with how they were presented in the review, taking account of legitimate differences.

Unit of analysis issues

The primary analysis was per woman randomised. We briefly summarised data that did not allow valid analysis (e.g. descriptive data) in additional tables and did not carry out meta‐analysis.

Dealing with missing data

We assessed the included studies for the number of women lost to follow‐up and exclusions from analysis after randomisation (dropouts). We did not impute missing variables for meta‐analysis.

Assessment of heterogeneity

We considered whether the clinical and methodological characteristics of the included studies were sufficiently similar for meta‐analysis to provide a clinically meaningful summary. We assessed statistical heterogeneity by the measure of the I² statistic. We took an I² measurement greater than 50% to indicate substantial heterogeneity (Higgins 2003; Higgins 2011).

Where statistical heterogeneity (i.e. I² > 50%) was apparent after pooling of data, we noted this and interpreted statistically significant results cautiously after further analysis using a random‐effects statistical model.

Assessment of reporting biases

In view of the difficulty of detecting and correcting for publication bias and other reporting biases, we aimed to minimise their potential impact by ensuring a comprehensive search for eligible studies and by being alert for duplication of data. If there were 10 or more studies in an analysis, we planned to use a funnel plot to explore the possibility of small study effects (a tendency for estimates of the intervention effect to be more beneficial in smaller studies).

Data synthesis

We stratified the analyses by the type of comparison and the subcategories within hysterectomy approaches.

We used a fixed‐effect model to calculate a pooled estimate of effect in meta‐analyses. If significant statistical heterogeneity was confirmed by the I² statistic (I² > 50%), we used a random‐effects model.

Subgroup analysis and investigation of heterogeneity

We analysed the overall category laparoscopic hysterectomy (LH) and further divided this category into total laparoscopic hysterectomy (TLH), laparoscopic‐assisted vaginal hysterectomy (LAVH) and non‐categorisable LH (NC‐LH) (Table 10).

3. Sub‐categorisation of laparoscopic hysterectomy.

Type of LH	LH versus AH RCTs	LH versus VH RCTs	LAVH versus TLH RCTs	LH versus SP‐LH RCTs	LH versus RH RCTs	LH versus V‐NOTES RCTs
LAVH	Ellstrom 1998 (IV)	Agostini 2006 (II)	Long 2002 (III)	Chen 2011 (III)
	Ferrari 2000 (III)	Darai 2001 (IV)	Roy 2011 (III)	Song 2013 (III)
	Kunz 1996 (II)	Eggemann 2018 (III)	Sesti 2014b (II)
	Marana 1999 (II)	Mohammed 2017 (IV)
	Muzii 2007 (III)	Ottosen 2000 (0)
	Olsson 1996 (IV)	Panda 2015*
	Ottosen 2000 (0)	Roy 2011 (III)
	Panda 2015*	Roy 2012 (III)
	Persson 2006 (IV)	Sesti 2008a (III)
	Raju 1994 (II)	Sesti 2008b (III)
	Schütz 2002 (IV)	Soriano 2001 (IV)
	Sesti 2008a (III)	Summitt 1992 (IV)
	Summitt 1998 (IV)	Zhu 2009 (IV)
	Tsai 2003 (III)
	Yuen 1998 (IV)
	Zhu 2009 (IV)
TLH	Allam 2015 (V)	Allam 2015 (V)	Ghezzi 2011	Chung 2015 (V)	Deimling 2016 (V)	Baekelandt 2019 (V)
	Ekanayake 2020 (V)	Candiani 2009 (V)	Long 2002 (V)	Jung 2011 (V)	Paraiso 2013 (V)	Park 2021 (V)
	Falcone 1999 (V)	Ekanayake 2020 (V)	Roy 2011 (V)	Mustea 2019 (V)	Sarlos 2012 (V)
	Harkki‐Siren 2000 (V)	Ghezzi 2010 (V)	Sesti 2014b (V)	Tormena 2017 (V)
	Hwang 2002 (V)	Hwang 2002 (V)
	Kluivers 2007 (V)	Nanavati 2016 (V)*
	Langebrekke 1996 (V)	Ribeiro 2003 (V)
	Nanavati 2016 (V)*	Roy 2011 (V)
	Perino 1999 (V)	Sesti 2014b (V)
	Ribeiro 2003 (V)
	Seracchioli 2002 (V)
Non‐categorisable LH	Garry 2004	Garry 2004		Kim 2015 (I‐IV)
	Kongwattanakul 2012	Richardson 1995
	Lumsden 2000
	Wakhloo 2015

AH: abdominal hysterectomy
LAVH: laparoscopic‐assisted vaginal hysterectomy
LH: laparoscopic hysterectomy
RCT: randomised controlled trial
TLH: total laparoscopic hysterectomy
VH: vaginal hysterectomy

We took any statistical heterogeneity into account when interpreting the results, particularly if there was any variation in the direction of effect. Where there was substantial heterogeneity (I² > 50%), we considered whether this was related to the subcategory of approach to hysterectomy.

Sensitivity analysis

We performed sensitivity analyses to examine the stability of the results in relation to the following factors.

• Exclusion of trials that we judged as at unclear risk of bias with regard to adequate sequence generation in the risk of bias table.

• Exclusion of trials comparing a surgical approach performed by one surgeon (or group of surgeons) with another surgical approach performed by a second (group of) surgeon(s).

• The effect of analysing studies of LH subcategories compared to studies of LH pooled as an overall category.

Summary of findings and assessment of the certainty of the evidence

We created summary of findings tables and measured and reported the overall certainty of the evidence for the primary outcomes (return to normal activities, satisfaction and quality of life, intraoperative visceral injury, major short‐term outcomes) based on the GRADE criteria. Our review included only RCTs. Thus, the certainty of the evidence was initially presumed high and downgraded based on risk of bias, inconsistency, indirectness, imprecision and publication bias. We classified the certainty of the evidence for each comparison as high, moderate, low or very low (Guyatt 2008). One review author (CP) initially applied the GRADE system and then discussed the certainty of evidence ratings for each outcome with three other members of the review team (AA, TB, DS). We reached final decisions on the ratings through discussion and consensus.

We created summary of findings tables for the following comparisons:

• Vaginal hysterectomy versus abdominal hysterectomy

• Laparoscopic hysterectomy versus abdominal hysterectomy

• Laparoscopic hysterectomy versus vaginal hysterectomy

• Robotic hysterectomy versus laparoscopic hysterectomy

• Single‐port laparoscopic hysterectomy versus laparoscopic hysterectomy

• Total laparoscopic hysterectomy versus laparoscopic‐assisted vaginal hysterectomy

• V‐NOTES hysterectomy versus laparoscopic hysterectomy

Results

Description of studies

Results of the search

In our initial search, we identified 7617 articles. Of these, 46 articles were potentially eligible, and we retrieved them in full text.

Of the 46 studies reviewed in full, 30 were excluded. The most common reason for exclusion was lack of randomisation.

In total this update added 16 new studies to the existing 47, creating a total of 63 studies included in the review.

For details on additional exclusion reasons see the study tables: Characteristics of included studies; Characteristics of excluded studies; Characteristics of studies awaiting classification and the PRISMA flow chart (Figure 1).

Where Olsson 1996 is mentioned in the review, we have used the data from Ellstrom 1998b where applicable. The eVALuate trial population was studied in two papers (Garry 2004; Sculpher 2004), and study quality was summarised under Garry 2004. There were multiple publications on different outcomes and outcome measures from the same randomised study population: Persson 2006 and Persson 2008 were summarised under Persson 2006; and the long‐term follow‐up study by Nieboer 2012 was summarised under Kluivers 2007. Ekanayake 2020 reported on vaginal, sexual and urinary symptoms following hysterectomy whereas Ekanayake 2021 reported on cost‐effectiveness outcomes from the same randomised controlled trial.

Included studies

See Characteristics of included studies for an overview of the included studies.

Study design

All included trials had a parallel‐group design. Fifty of the trials were single‐centre studies (10 from Italy; five from India; four from Korea, the USA and Taiwan; three from Brazil and Germany; two each from the UK, China, Egypt, Sweden and France; and one each from Belgium, Finland, Pakistan, the Netherlands, Switzerland, Thailand and Hong Kong). Of the 13 multicentre trials, five trials recruited from two centres (Darai 2001 based in France; Langebrekke 1996 based in Norway; Miskry 2003 based in the UK; Paraiso 2013 based in the USA; Ekanayake 2020 based in Sri Lanka). Four trials recruited from three centres (Summitt 1998 based in the USA; Lumsden 2000 based in the UK; Muzii 2007 based in Italy and Mustea 2019 based in Germany). One trial from Italy recruited from four centres (Marana 1999); one Swedish trial recruited from five centres (Persson 2006); one Korean trial recruited from eight centres (Kim 2015), and a trial based in the UK with additional centres in South Africa (Garry 2004) recruited from 30 centres.

Participants

The 63 studies involved 6811 women.

The reported mean age of participants in the study groups ranged from 38 (Summitt 1992) to 55 years (Agostini 2006).

All included studies recruited women who needed a hysterectomy for benign causes; 10 studies specifically included women who underwent hysterectomy for symptomatic uterine fibroids (Benassi 2002; Ferrari 2000; Hwang 2002; Kim 2015; Long 2002; Mohammed 2017; Ribeiro 2003; Sesti 2008a; Sesti 2014b; Tsai 2003).

Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH)

Five studies specifically compared vaginal to abdominal routes of hysterectomy. Benassi 2002 included women with symptomatic enlarged fibroid uteri. Silva Filho 2006 included women with myoma and a uterine size less than 300 cm³. Parveen 2013 included women with uterus less than 14 weeks size. Chakraborty 2011 and Miskry 2003 included women who needed hysterectomy for a benign condition.

Laparoscopic hysterectomy (LH) versus AH

Fourteen of the 22 studies that compared LH with AH specifically included women who were scheduled for an abdominal hysterectomy or who had contraindications for a vaginal hysterectomy (Ellstrom 1998; Falcone 1999; Ferrari 2000; Harkki‐Siren 2000; Kluivers 2007; Kongwattanakul 2012; Lumsden 2000; Marana 1999; Muzii 2007; Olsson 1996; Seracchioli 2002; Summitt 1998; Tsai 2003; Yuen 1998).

LH (including all forms of LH) versus VH

Twelve studies compared LH to VH. Multiple studies (n = 4) either included women if their uterine size was larger than a certain number (e.g. more than 280 g (Darai 2001; Mohammed 2017; Soriano 2001) or between 300 g and 1500 g (Roy 2012). Studies (n = 5) also excluded women if their uterine size was greater than, for instance, 14 weeks (Ghezzi 2010) or 16 weeks of pregnancy (Richardson 1995; Sesti 2008b; Sesti 2014b; Summitt 1992). One study required that two separate surgeons deem vaginal hysterectomy an appropriate route (Eggemann 2018). Two studies specifically included women with symptomatic or rapidly growing myoma (Sesti 2008b, Sesti 2014b).

VH versus LH and AH versus LH

One publication reported on two parallel randomised trials that included women scheduled for hysterectomy for non‐malignant conditions with uterine size less than 12 weeks (Garry 2004).

LH versus AH versus VH

Seven studies had three arms with comparisons between all three routes (VH, LH, AH) (Allam 2015; Ekanayake 2021; Hwang 2002; Nanavati 2016; Ottosen 2000; Panda 2015; Ribeiro 2003).

Four trials specifically included women with uterine fibroids: e.g. leiomyomas of less than 15 cm (Ottosen 2000), leiomyomas of more than 8 cm and a maximum of three myomas (Hwang 2002), symptomatic myoma (Sesti 2008a), or any fibroid (Ribeiro 2003). Others excluded participants based on uterine size greater than 12 weeks (Nanavati 2016; Zhu 2009), 14 weeks (Ekanayake 2020; Panda 2015), or 16 weeks (Allam 2015).

Robotic‐assisted hysterectomy (RH) versus LH

Three studies compared RH to LH in women with benign indications for hysterectomy. In Sarlos 2012, uterine weight had to be less than 500 g. Deimling 2016 and Paraiso 2013 did not use uterine size as an exclusion criterion.

Single‐port laparoscopic hysterectomy (SP‐LH) versus LH

Seven studies compared single port to traditional laparoscopic hysterectomy for women with an indication for hysterectomy and no evidence of gynaecologic malignancy. Uterine size was used as an exclusion criterion as follows: more than 12 weeks gestation (Jung 2011), more than 18 weeks (Chung 2015; Kim 2015), more than 20 weeks (Song 2013), uterine volume greater than 600 cm³ (Tormena 2017), and uterine size greater than 120 mm x 80 mm x 80 mm (Chen 2011). Mustea 2019 did not use uterine size as an exclusion criterion, and it is unclear if any participants had leiomyoma as this was not listed as an indication for surgery.

LAVH versus total laparoscopic hysterectomy (TLH)

Three studies included the comparison of LAVH to TLH. In Long 2002 women were included if they had contraindications for vaginal hysterectomy (a uterine weight greater than 280 g, previous pelvic surgery, pelvic inflammatory disease, need for adnexectomy, lack of uterine descent and limited vaginal access). Roy 2011 and Sesti 2014b both had three arms (LAVH, TLH, VH) and thus are also described in the LH versus VH section above. Women were included in Roy 2011 if they had benign pathology and uterine weight less than 400 g. Sesti 2014b included women with symptomatic fibroids and a uterine size between 12 and 16 weeks.

LH versus V‐NOTES hysterectomy

Neither Baekelandt 2019 nor Park 2021 used uterine size as an inclusion or exclusion criterion and included only women requiring hysterectomy for benign disease. Park 2021 excluded women with three or more caesareans or other risks for severe adhesive disease.

Interventions

Surgical procedures

VH versus AH

Five trials directly compared VH with AH (Benassi 2002; Chakraborty 2011; Miskry 2003; Parveen 2013; Silva Filho 2006). Hysterectomies were performed by standard technique for each route.

LH versus AH

Nineteen trials compared LH to AH (Ellstrom 1998; Falcone 1999; Ferrari 2000; Harkki‐Siren 2000; Kluivers 2007; Kunz 1996; Langebrekke 1996; Lumsden 2000; Marana 1999; Muzii 2007; Perino 1999; Raju 1994; Seracchioli 2002; Sesti 2008a; Schütz 2002; Summitt 1998; Tsai 2003; Wakhloo 2015; Yuen 1998). Raju 1994 compared LH and bilateral salpingo‐oophorectomy (LH‐BSO) with AH‐BSO. Ellstrom 1998 stratified the two randomised groups (LH and AH) into total and subtotal hysterectomies. Muzii 2007 performed mini‐laparotomy for AH (with a moving surgical field or window using three separate retractors). Sesti 2008a compared LAVH and AH.

LH versus VH

Twelve trials compared laparoscopic hysterectomy (LH) with vaginal hysterectomy (VH) (Agostini 2006; Candiani 2009; Darai 2001; Eggemann 2018; Ghezzi 2010; Mohammed 2017; Richardson 1995; Roy 2012; Sesti 2008b; Sesti 2014b; Soriano 2001; Summitt 1992).

VH versus LH and AH versus LH

One publication was a very large RCT comparing LH (called vLH in the trial) with VH and LH (called aLH in the trial) with AH (Garry 2004); it was essentially two concurrent RCTs as part of the same study.

VH versus AH versus LH

Seven trials had three arms comparing VH, AH and LH (Allam 2015; Ekanayake 2020; Hwang 2002; Nanavati 2016; Ottosen 2000; Panda 2015; Ribeiro 2003). These studies make direct comparisons between each of the arms, therefore they contribute data to the first three comparison groups listed above.

RH versus LH

Deimling 2016, Paraiso 2013 and Sarlos 2012 compared conventional laparoscopic to robotically assisted hysterectomy.

SP‐LH versus LH

Chen 2011 and Mustea 2019 compared SP‐LAVH versus LAVH, whereas Chung 2015, Jung 2011, Song 2013 and Tormena 2017 compared SP‐LH versus TLH. Kim 2015 was conducted across multiple centres where a combination of LAVH and TLH procedures were performed depending on the site.

LAVH versus TLH

Long 2002 directly compared LAVH to TLH. Data from Roy 2011 and Sesti 2014b are included in this comparison as well since these studies both had three arms (LAVH, TLH, VH).

LH versus V‐NOTES hysterectomy

Baekelandt 2019 compared TLH to the V‐NOTES procedure whereas Park 2021 compared SP‐LH to V‐NOTES.

LH subcategories

All the trials that included a laparoscopic hysterectomy comparison used the term 'laparoscopic hysterectomy' in their description of the procedure. However, their definitions varied according to what stages of the hysterectomy were completed laparoscopically and the point at which the operation continued vaginally. As discussed in the background section, we included all trials with hysterectomies that had some laparoscopic component in the overall LH category and created three subclassifications of LH for the meta‐analysis: LAVH, TLH and non‐categorisable LH.

Using the Richardson classification system (Richardson 1995), we were able to further classify 43 of the 51 included studies that involved LH according to the amount of laparoscopic content (see Table 10). According to Richardson staging, one trial involved stage zero LH (Ottosen 2000), five trials were stage two (Agostini 2006; Kunz 1996; Marana 1999; Sesti 2014b), 10 trials were stage three (Chen 2011; Eggemann 2018; Ferrari 2000; Muzii 2007; Roy 2011; Roy 2012; Sesti 2008a; Sesti 2008b; Song 2013; Tsai 2003), 11 trials were stage four, where the uterine artery was transected laparoscopically (Darai 2001; Ellstrom 1998; Mohammed 2017; Olsson 1996; Persson 2006; Schütz 2002; Soriano 2001; Summitt 1992; Summitt 1998; Yuen 1998; Zhu 2009), and 23 trials were stage five (Allam 2015; Baekelandt 2019; Candiani 2009; Chung 2015; Deimling 2016; Ekanayake 2020; Falcone 1999; Ghezzi 2010; Harkki‐Siren 2000; Hwang 2002; Jung 2011; Kluivers 2007; Langebrekke 1996;Mustea 2019;Nanavati 2016; Paraiso 2013; Park 2021; Perino 1999; Ribeiro 2003; Sarlos 2012; Seracchioli 2002; Sesti 2014b; Tormena 2017). Of the 23 trials involving stage V laparoscopic hysterectomies, eight performed a laparoscopic cuff closure (Allam 2015; Baekelandt 2019; Chung 2015; Kluivers 2007; Paraiso 2013; Park 2021; Ribeiro 2003; Sarlos 2012). Three performed a combination of laparoscopic and vaginal closures depending on the individual case (Jung 2011; Perino 1999; Tormena 2017), and five performed only vaginal cuff closure (Deimling 2016; Falcone 1999; Hwang 2002; Langebrekke 1996; Seracchioli 2002). Seven do not describe their cuff closure technique (Candiani 2009; Ekanayake 2020; Ghezzi 2010; Harkki‐Siren 2000; Mustea 2019; Nanavati 2016; Sesti 2014b).

In Nanavati 2016, the authors report performing a 'total laparoscopic hysterectomy' and thus we included it in the TLH category, though no description of the procedure is included. Panda 2015 is included in our LAVH category because authors report doing a 'laparoscopically assisted vaginal hysterectomy' but we were not able to assign a Richardson classification as no further description of the procedure was provided. In total there were six trials where we were unable to sub‐categorise the LH procedures, and we described these as 'non‐categorisable LH' (Chakraborty 2011;Garry 2004; Kim 2015; Kongwattanakul 2012; Lumsden 2000; Richardson 1995; Wakhloo 2015). Richardson 1995 and Kim 2015 had LHs of all stages from 0 to 5, and the other trials did not stipulate the LH methods performed (Chakraborty 2011; Garry 2004; Kongwattanakul 2012; Lumsden 2000; Wakhloo 2015).

Outcomes

With respect to our primary outcomes, 17 studies reported on time needed to return to normal activities (Ekanayake 2021; Harkki‐Siren 2000; Hwang 2002; Langebrekke 1996; Miskry 2003; Olsson 1996; Ottosen 2000; Paraiso 2013; Persson 2006; Raju 1994; Richardson 1995; Roy 2011; Roy 2012; Sarlos 2012; Schütz 2002; Seracchioli 2002; Summitt 1998).

Two studies reported on satisfaction (Benassi 2002; Lumsden 2000), and seven studies reported on quality of life (Garry 2004; Kluivers 2007; Lumsden 2000; Olsson 1996; Persson 2006; Roy 2011; Silva Filho 2006). Four trials included sexual activity or body image in the analysis (Candiani 2009; Garry 2004; Long 2002; Song 2013).

Thirty‐four studies reported on intraoperative visceral injury (Allam 2015; Baekelandt 2019; Benassi 2002; Chakraborty 2011; Darai 2001; Deimling 2016; Eggemann 2018; Ekanayake 2021; Garry 2004; Jung 2011; Kim 2015; Kluivers 2007; Kongwattanakul 2012; Langebrekke 1996; Long 2002; Lumsden 2000; Marana 1999; Mohammed 2017; Nanavati 2016; Olsson 1996; Ottosen 2000; Panda 2015; Parveen 2013; Perino 1999; Persson 2006; Raju 1994; Ribeiro 2003; Richardson 1995; Roy 2011; Sarlos 2012; Summitt 1992; Summitt 1998; Tsai 2003; Wakhloo 2015).

Seven studies reported on major long‐term complications (Ekanayake 2020; Long 2002; Lumsden 2000; Olsson 1996; Ottosen 2000; Perino 1999; Summitt 1992).

Fifty‐nine trials assessed the length of postoperative hospital stay. Eleven studies included an analysis of costs (Benassi 2002; Chung 2015; Ekanayake 2021; Ellstrom 1998; Falcone 1999; Garry 2004; Lumsden 2000; Mohammed 2017; Raju 1994; Summitt 1992; Summitt 1998).

Most of the trials assessed the operation times and intra‐ or postoperative complications. Lumsden 2000 and Garry 2004 split the complications into major and minor. Febrile episodes or unspecified infection were measured in 20 trials. Sixteen trials reported any operations that were converted to abdominal surgery (Allam 2015; Darai 2001; Eggemann 2018; Garry 2004; Kluivers 2007; Marana 1999; Mohammed 2017; Muzii 2007; Ottosen 2000; Persson 2006; Richardson 1995; Seracchioli 2002; Sesti 2014b; Soriano 2001; Summitt 1992; Summitt 1998).

Excluded studies

See Characteristics of excluded studies for an overview of the excluded studies, including the reasons why they were excluded from the review.

Risk of bias in included studies

An overview of the risk of bias is provided in Figure 2 and Figure 3. One study fulfilled all criteria for adequate management of risk of bias (Eggemann 2018). Six studies met none of the criteria for adequate management of risk of bias (Long 2002; Nanavati 2016; Panda 2015; Tormena 2017; Wakhloo 2015; Zhu 2009).

2.

Risk of bias summary: review authors' judgements about each methodological quality item presented as percentages across all included studies.

3.

Allocation

Sequence generation

Twenty‐seven studies randomised using a computer (Agostini 2006; Allam 2015; Baekelandt 2019; Candiani 2009; Chen 2011; Chung 2015; Eggemann 2018; Ekanayake 2020; Ferrari 2000; Garry 2004; Ghezzi 2010; Ghezzi 2011; Hwang 2002; Kim 2015; Miskry 2003; Mohammed 2017; Muzii 2007; Ottosen 2000; Paraiso 2013; Park 2021; Raju 1994; Schütz 2002; Sesti 2008a; Sesti 2008b; Sesti 2014b; Song 2013; Tormena 2017). Langebrekke 1996, Parveen 2013 and Richardson 1995 used a table of random digits for randomisation. Ten trials used a computer‐generated randomisation code (Benassi 2002; Darai 2001; Falcone 1999; Lumsden 2000; Marana 1999; Seracchioli 2002; Soriano 2001; Summitt 1992; Roy 2012; Tsai 2003; Yuen 1998). Seventeen trials did not report the randomisation method (Chakraborty 2011; Ellstrom 1998; Harkki‐Siren 2000; Kluivers 2007Kunz 1996; Long 2002; Mustea 2019; Nanavati 2016; Olsson 1996; Panda 2015; Perino 1999; Ribeiro 2003; Roy 2011; Silva Filho 2006; Tormena 2017; Wakhloo 2015; Zhu 2009). Overall, we considered 45 studies to have low risk of bias and 18 studies to have unclear risk of bias.

Allocation concealment

Twenty‐five studies used sealed, opaque envelopes (Agostini 2006; Baekelandt 2019; Candiani 2009; Chen 2011; Deimling 2016; Ferrari 2000; Ghezzi 2010; Ghezzi 2011; Harkki‐Siren 2000; Hwang 2002; Kim 2015; Kluivers 2007; Langebrekke 1996; Miskry 2003; Mohammed 2017; Muzii 2007; Olsson 1996; Ottosen 2000; Persson 2006; Raju 1994; Sesti 2008a; Sesti 2014b; Sesti 2008b; Song 2013; Summitt 1998). For instance, Persson 2006 numbered the envelopes according to a random list, and Kluivers 2007 sealed the envelopes after which they were shuffled and numbered by a third party. Two trials used a telephone (Garry 2004; Schütz 2002). Thirty trials did not report whether allocation was concealed (Benassi 2002; Darai 2001; Ellstrom 1998; Falcone 1999; Ghezzi 2010; Jung 2011; Kunz 1996; Long 2002; Marana 1999; Mustea 2019; Nanavati 2016; Panda 2015; Paraiso 2013; Park 2021; Parveen 2013; Perino 1999; Ribeiro 2003; Roy 2011; Roy 2012; Sarlos 2012; Seracchioli 2002; Sesti 2014b; Silva Filho 2006; Soriano 2001; Summitt 1992; Tormena 2017; Tsai 2003; Yuen 1998; Wakhloo 2015; Zhu 2009). We identified no studies as having high risk of bias; in 30 studies it was unclear, and 33 studies had low risk of bias.

Blinding

One trial reported non‐therapeutic skin incisions to blind patients and outcome assessors to the intervention performed (Baekelandt 2019). Multiple trials used sham abdominal dressings to attempt to blind patients and personnel (Chung 2015; Eggemann 2018; Miskry 2003; Mustea 2019). Paraiso 2013 reported blinding of patients for the intervention. In Kongwattanakul 2012, Sesti 2008a and Sesti 2014b the researchers were blinded. One trial reported blinding of the interviewer one month after surgery (Silva Filho 2006). All other trials included in this review did not apply any blinding of participants, clinicians or researchers, resulting in high risk of performance and detection bias. Overall, six studies had a low risk of bias, four an unclear risk of bias and 53 studies a high risk of bias.

Incomplete outcome data

We considered attrition bias to be low in 40 trials, unclear in 12 trials and high in 11 trials.

In the Long 2002 trial, women were randomised to treatment groups before a large number (i.e. 66) of the women were excluded. Therefore, the women in each treatment group may not have been a true representation of the original randomised groups.

Dropouts

Thirty‐one trials reported no dropouts. Twenty‐four trials reported dropouts, with the dropout rate ranging from 1.7% to 20%. Table 11 lists the trials that reported dropouts with the dropout circumstances. In eight trials the dropouts were excluded from the data analysis (Chung 2015; Long 2002; Lumsden 2000; Mustea 2019; Persson 2006; Summitt 1998; Tormena 2017; Yuen 1998), whereas the other five either included the data in the analysis where possible (Deimling 2016; Kim 2015; Falcone 1999; Kluivers 2007; Paraiso 2013; Sarlos 2012), or performed a sensitivity analysis for the missing data (Garry 2004). Four trials had women withdraw pre‐operatively: Kim 2015 (5 out of 256), Falcone 1999 (4 out of 48), Garry 2004 (34 out of 1380) and Persson 2006 (1 out of 119). In the Lumsden 2000 study, seven women withdrew pre‐operatively and case records were not available for three more. Two and one women respectively refused their assigned procedure in the Summitt 1998 and Kluivers 2007 studies; in the Yuen 1998 study, four women declined their assigned operation and a further two women refused to participate postoperatively. In the Long 2002 trial, excluded post‐randomisation were: three women undergoing conversion to laparotomy, seven with incomplete records and three with combined procedures. A further 53 were excluded because they did not have indications of uterine fibroids or adenomyosis. In the Persson 2006 trial, five patients allocated to AH and one to LH withdrew after giving informed consent prior to the operation or withdrew in the postoperative period before the five‐week follow‐up. In the Paraiso 2013 trial, six patients dropped out before the intervention was performed, after randomisation. These were analysed in the allocated intervention arm.

4. Studies reporting dropouts.

Trial	No. dropouts	Details
Chen 2011	2	Excluded from analysis postoperatively, because they underwent accessory adnexal surgery
Chung 2015	2 (1 TLH, 1 SP‐TLH)	One person in each of the groups was excluded from the analysis because they did not use the postop PCA for pain control (one due to NV, one due to error)
Deimling 2016	1 (TLH)	One patient assigned to the TLH group had severe adhesions and hysterectomy was aborted
Falcone 1999	4 (1 LH; 3 AH)	Withdrew pre‐operatively
Kim 2015	5 (3 SP‐LH; 2 LH)	Withdrew pre‐operatively
Garry 2004	34 (23 LH (11 aLH; 12 vLH); 6 AH; 5 VH)	Withdrew pre‐operatively
Long 2002	13	3 laparotomy conversions were excluded from analysis; 7 incomplete records; 3 combined procedures that were excluded post‐randomisation
Lumsden 2000	10	10 dropouts were not analysed. 7 women did not attend surgery and 3 records were not available
Kluivers 2007	1	Refused assignment procedure
Lumsden 2000	10	7 withdrew pre‐operatively; 3 case records not available
Mustea 2019	4	Unclear/not reported
Paraiso 2013	6	6 withdrew after randomisation but before the intervention was performed
Persson 2006	6	5 allocated to AH and 1 to LH withdrew after informed consent prior to the operation or withdrew in the postoperative period before the 5‐week follow‐up
Roy 2011	9	5 excluded because they needed adenectomy during surgery and 4 excluded from all analyses because they did not show up for follow‐up after intervention
Roy 2012	1	1 LH patient excluded from analysis due to conversion
Sarlos 2012	5	After randomisation 5 did not complete the study and were excluded from the analysis
Song 2013	1	1 lost to follow‐up because of dissatisfaction with hospital care
Summitt 1998	2	Refused assignment procedure
Tormena 2017	2 (1 SP‐LH, 1 LH)	One was converted to multi‐port laparoscopy for extensive adhesions, another no‐showed their follow‐up appointment. Both were excluded from analysis
Yuen 1998	6	4 declined operation; 2 refused to participate postoperatively

AH: abdominal hysterectomy
aLH: laparoscopic cases in the abdominal arm of the eVALuate trial
LH: laparoscopic hysterectomy
VH: vaginal hysterectomy
vLH: laparoscopic cases in the vaginal arm of the eVALuate trial

Loss to follow‐up

In 12 trials the follow‐up period was not specified (and considered an unclear risk of bias), the number analysed in the follow‐up period was not reported, or the loss to follow‐up was between 5% and 10% of the patient population (Allam 2015; Mohammed 2017; Mustea 2019; Nanavati 2016; Panda 2015; Persson 2006; Sarlos 2012; Summitt 1992; Tsai 2003; Wakhloo 2015; Yuen 1998; Zhu 2009). Seven studies lost more than 10% of their patient population in the follow‐up period (Candiani 2009; Kluivers 2007; Long 2002; Lumsden 2000; Roy 2011; Roy 2012; Schütz 2002).

Intention‐to‐treat

Of the 24 RCTs reporting dropouts, nine reported analysis by intention‐to‐treat (ITT), defined as all randomised women reported upon according to their group of randomised allocation (Deimling 2016; Falcone 1999; Garry 2004; Kim 2015; Kluivers 2007; Paraiso 2013; Persson 2006; Sarlos 2012; Sesti 2008a). The remaining RCTs reporting dropouts did not report ITT analysis of all randomised women. One further trial that had no dropouts did not analyse by ITT but according to the treatment received, which was different to the assigned treatment in two cases: the operation was converted from LH to AH and these women were analysed in the AH group (Tsai 2003). Similarly, in Panda 2015 there were conversions (four in the LAVH group and one in the VH group) to AH, which were considered failed procedures and omitted from the analysis.

Selective reporting

We considered selective reporting bias to be low in 27 studies, unclear in 35 studies and high in one study. Twenty‐eight studies reported pre‐defined outcomes and reported on these outcomes in their study publications. We considered all but one of these studies low risk. Panda 2015 had predefined outcomes but did not specify a primary outcome, and we therefore considered it to have unclear risk of bias. We also considered 34 additional studies to have unclear risk of bias because they provided insufficient information to determine whether primary or secondary outcomes had been predefined. We considered one study to have high risk of bias. Wakhloo 2015 did not report pre‐defined primary or secondary outcomes. In addition, the authors mention that at each visit patients were asked about their recovery towards household functions and sexual activity. However, they do not mention this outcome in the results section, nor in any table or the discussion.

Other potential sources of bias

We judged the risk of potential other bias as follows: low risk of bias in 26 studies, unclear risk of bias in 24 studies and high risk of bias (three or more other potential sources of bias) in 13 studies.

Differences in baseline characteristics

In seven studies, baseline characteristics differed between intervention groups (Allam 2015; Chakraborty 2011; Deimling 2016; Eggemann 2018; Hwang 2002; Panda 2015; Park 2021). In three studies, baseline characteristics were not reported (Nanavati 2016; Kongwattanakul 2012; Parveen 2013). In Kluivers 2007, the AH group had more residents as a first surgeon than the other two groups. In the other studies no other bias could be identified.

Surgeon's experience

The surgeon's experience or level of training was reported in 41 of the trials and was not considered as a potential source of bias. In the remaining 22 studies the surgeon's experience was not reported or specified or varied substantially between groups. The studies by Benassi 2002, Chakraborty 2011, Chen 2011, Ellstrom 1998, Ferrari 2000, Hwang 2002, Kunz 1996, Mohammed 2017, Panda 2015, Parveen 2013, Tsai 2003, Tormena 2017 and Wakhloo 2015 did not report or specify the surgeon's experience for the interventions evaluated. In five trials, surgeons for one intervention were different to those performing the other intervention: Olsson 1996 (LH carried out by two out of five senior registrar grade surgeons trained in LH, AH carried out by two out of 10 senior registrar grade surgeons trained in AH); Langebrekke 1996 (LH performed exclusively by the two authors, AH performed by any skilled gynaecologist in the department); Raju 1994 (LAVH performed by one of the authors, AH by one of the authors or a senior registrar grade surgeon); Kluivers 2007 (LH was performed or supervised (resident 39%) by three out of 10 experienced gynaecologists (at least 100 LHs), AH performed or supervised by all 10 gynaecologists); and Long 2002 (one surgeon performed all LAVH, another performed all TLH). Residents were the first surgeon in 39% of LH and 88% of AH. In Agostini 2006, the five surgeons were experienced in vaginal surgery, but laparoscopic experience was not reported. In Ottosen 2000, 15 gynaecological surgeons with assistants performed the operations; their experience varied and there were cases of residents performing operations under supervision. In Eggemann 2018, 12 different surgeons were involved in the study, and it is noted that they had more experience with VH than LAVH, but this experience is not quantified. In Schütz 2002, 71% of LH were performed by the attending physician and 29% by a resident under supervision, and 40% of AH were performed by the attending physician and 60% by the resident under supervision. One trial used only gynaecological residents to perform all the operations with the assistance of the attending physician (Summitt 1998). It is unlikely that any of the latter four trials used the same group of surgeons for both intervention groups. In three other trials it was unclear if the surgeons performing the operations were different: Darai 2001 (all experienced in laparoscopic and vaginal surgery but no mention of who performed each intervention); Perino 1999 (LH by team of three laparoscopic surgeons with experience of more than 100 LHs, no details provided for AH arm); and Falcone 1999 (one of the senior authors performed all the LH operations with the assistance of a pelvic surgery fellow or resident, but no mention of the AH group).

Source of funding

Four studies received funding from pharmaceutical or surgical instrumentation companies: Falcone 1999 received part of the funding from Ethicon Endosurgery Inc; Harkki‐Siren 2000 received a part of its funding from the Research Foundation of the Orion Corporation; Kim 2015 received a funding contribution from Covidien; Summitt 1998 received all of its funding from US Surgical Corporation, USA.

Other bias

If a trial lacked information, such as a description of one of the interventions or details on the inclusion or exclusion criteria, we considered this a possible source of other bias.

Effects of interventions

See: Table 1; Table 2; Table 3; Table 4; Table 5; Table 6; Table 7

1 Vaginal hysterectomy (VH) versus abdominal hysterectomy (AH)

Primary outcomes

1.1 Return to normal activities

For vaginal versus abdominal hysterectomy, patients probably returned to normal activities sooner after VH (mean difference (MD) ‐10.91 days, 95% confidence interval (CI) ‐17.95 to ‐3.87); 4 randomised controlled trials (RCTs), 274 women; I² = 67%; moderate‐certainty evidence) (Figure 2; Analysis 1.1). This suggests that if the return to normal activities after abdominal hysterectomy is assumed to be 42 days, then after vaginal hysterectomy it would be between 24 and 38 days.

1.1. Analysis.

Comparison 1: VH versus AH, Outcome 1: Return to normal activities (days)

1.2 Satisfaction and quality of life

We are uncertain whether there is a difference in patient satisfaction between vaginal and abdominal hysterectomy, although the point estimate favoured VH (odds ratio (OR) 2.69, 95% CI 0.50 to 14.42; 1 RCT, 119 women; I² = n/a, low‐certainty evidence) (Analysis 1.2). This suggests that in women with a 91% satisfaction rate after abdominal hysterectomy, the satisfaction rate after vaginal hysterectomy would be between 84% and 99%.

1.2. Analysis.

Comparison 1: VH versus AH, Outcome 2: Long‐term outcomes: satisfaction (dichotomous)

Silva Filho 2006 found better quality of life after vaginal hysterectomy, compared to abdominal hysterectomy, in the SF‐36 subscales for functional capacity (means VH versus AH: 95 versus 73), physical aspects (means VH versus AH: 100 versus 38) and pain (means VH versus AH: 84 versus 51). Additionally, a higher rate of patients who underwent vaginal hysterectomy would choose the same treatment again (Analysis 1.8).

1.8. Analysis.

Comparison 1: VH versus AH, Outcome 8: All outcomes, descriptive data

All outcomes, descriptive data
Study	Description	VH	AH	Conclusion
Quality of life (descriptive data)
Silva Filho 2006	Questionnaire SF‐36. Only data from functional capacity, physical aspect and pain are presented. A high score is a better quality of life	n = 30 1 month after surgery, response rate 100%	n = 30 1 month after surgery, response rate 100%	Functional capacity: VH mean = 95, IQ‐range = 75 to 100. AH mean = 72.5, IQR = 55 to 90 Physical aspect: VH mean = 100, IQ‐range = 25 to 100. AH mean = 37.5, IQR = 0 to 100 Pain: VH mean = 84, IQR = 59.2 to 100. AH mean = 51, IQ‐range = 41 to 65. A higher rate of patients in VH would choose the same therapeutic modality (90% versus 65.5%, P value = 0.021)
Operation time (descriptive data)
Ekanayake 2021		n = 49 Median = 50 mins IQR (35 to 65)	n = 49 Median = 45 mins IQR (36.5 to 60)	Not tested separately
Hwang 2002		With 2nd procedure: median = 93 range = 80 to 110 n = 3 Without 2nd procedure: median = 74 range = 40 to 120 n = 27	With 2nd procedure: median = 117 range = 90 to 190 n = 8 Without 2nd procedure: median = 98 range = 85 to 150 n = 22	Not tested separately
Miskry 2003		Mean 68.8 (range 30 to 180) mins n = 18	Mean 68.2 (range 45 to 174) mins n = 18	‐
Nanavati 2016		n = 50 mean 77.5 mins no IQR/SD given	n = 50 mean 75 mins no IQR/SD given	no P value
Ribeiro 2003		Mean 78 mins n = 20	Mean 109 mins n = 20	No measure of spread stated
Length of hospital stay (descriptive data)
Allam 2015		n = 30 median 1.5 IQR (1.5 to 2)	n = 30 median 1.5 days IQR (1 to 2)	Estimated with the Kruskal–Wallis test P < 0.001
Ekanayake 2021		n = 49 median = 3 days IQR (2 to 3)	n = 49 median = 3 days IQR (2 to 3)	Not tested separately
Hwang 2002		n = 30 median = 4.7 days range (3 to 7)	n = 30 median = 5 days range (4 to 8)	Not tested separately
Nanavati 2016		n = 50 4 days no IQR or SD given	n = 50 6 days no IQR or SD given	No P value
Ribeiro 2003		n = 20 All went home on second postoperative day	n = 20 All went home on third postoperative day	—
Urinary and sexual dysfunction (descriptive data)
Ekanayake 2020	Questionnaire ICIQ‐LUTS. Urinary symptoms pre‐operatively, 6 months and 1 year postoperatively. A high score means experiencing more urinary symptoms	Urinary flow symptoms: Pre‐op: n = 49 median = 3 IQR (2 to 5) 6 months postop: n = 48 median = 2 IQR (0 to 4.75) 1 year postop: n = 45 median = 2 IQR (0.5 to 4) Urinary voiding symptoms: Pre‐op: n = 49 median = 0 IQR (0 to 1) 6 months postop: n = 48 median = 0 IQR (0 to 0.75) 1 year postop: n = 45 median = 0 IQR (0 to 1) Urinary incontinence symptoms: Pre‐op: n = 49 median = 0 IQR (0 to 3) 6 months postop: n = 48 median = 1 IQR (0.75 to 3) 1 year postop: n = 45 median = 0 IQR (0 to 3)	Urinary flow symptoms: Pre‐op: n = 49 median = 2 IQR (1 ‐ 4) 6 months postop: n = 49 median = 1 IQR (0 ‐ 3) 1 year postop: n = 47 median = 1 IQR (0 ‐ 3) Urinary voiding symptoms: Pre‐op: n = 49 median = 0 IQR (0 ‐ 0) 6 months postop: n = 49 median = 0 IQR (0 ‐ 0) 1 year postop: n = 47 median = 0 IQR (0 ‐ 0) Urinary incontinence symptoms: Pre‐op: n = 49 median = 0 IQR (0 ‐ 2) 6 months postop: n = 49 median = 0 IQR (0 ‐ 2) 1 year postop: n = 47 median = 0 IQR (0 ‐ 2)	Urinary flow symptoms: NDVH 6 months postoperative score versus pre‐operative score: P < 0.001 NDVH 1 year postoperative score versus pre‐operative score: P < 0.001 TAH 6 months postoperative score versus pre‐operative score: P < 0.001 TAH 1 year postoperative score versus pre‐operative score: P < 0.001 Urinary voiding symptoms: NDVH 6 months postoperative score versus pre‐operative score: P < 0.05 NDVH 1 year postoperative score versus pre‐operative score: P < 0.05 TAH 6 months postoperative score versus pre‐operative score: P = 0.47 TAH 1 year postoperative score versus pre‐operative score: P = 0.20 Urinary incontinence symptoms: NDVH 6 months postoperative score versus pre‐operative score: P = 0.07 NDVH 1 year postoperative score versus pre‐operative score: P < 0.01 TAH 6 months postoperative score versus pre‐operative score: P = 0.06 TAH 1 year postoperative score versus pre‐operative score: P < 0.01
Ekanayake 2020	Questionnaire ICIQ‐VS. Sexual symptoms pre‐operatively, 6 months and 1 year postoperatively. A high score means experiencing more sexual symptoms	Pre‐operatively: n = 49 median = 0 IQR (0 to 0) 6 months postoperatively: n = 29 median = 0 IQR (0 to 0) 1 year postoperatively: n = 28 median = 0 IQR (0 to 0)	Pre‐operatively: n = 49 median = 0 IQR (0 to 11.5) 6 months postoperatively: n = 23 median = 0 IQR (0 to 10) 1 year postoperatively: n = 22 median = 0 IQR (0 to 14)	NDVH group: 6 months postoperative score versus pre‐operative score: P = 0.69 1 year postoperative score versus pre‐operative score: P = 0.46 TAH group: 6 months postoperative score versus pre‐operative score: P < 0.05 1 year postoperative score versus pre‐operative score: P = 0.08
Ekanayake 2020	Questionnaire ICIQ‐VS. Vaginal symptoms pre‐operatively, 6 months and 1 year postoperatively. A high score means experiencing more vaginal symptoms	Pre‐operatively: n = 49 median = 6 IQR (4 to 8.5) 6 months post‐operatively: n = 48 median = 4 IQR (0 to 8) 1 year post‐operatively: n = 45 median = 5 IQR (0 to 8)	Pre‐operatively: n = 49 median = 6 IQR (2 to 8) 6 months postoperatively: n = 49 median = 4 IQR (0 to 8) 1 year postoperatively: n = 47 median = 4 IQR (0 to 8)	For both the TAH and NDVH group vaginal function domain scores at 6 months and 1 year postoperatively were statistically significant compared to the respective pre‐operative scores (P < 0.001)
Cost (descriptive data)
Benassi 2002	Average cost of the procedure, including hospital stay. The currency being reported is unclear, although the study was conducted in Parma, Italy.	58,581	71,882
Ekanayake 2021	Direct cost in US dollars (USD) (mean, 95% CI)	800 (622 to 1116)	59 (632 to 687)

1.3 Intraoperative visceral injury

We are uncertain whether there is a difference in rates of bladder injury after vaginal versus abdominal hysterectomy (OR 1.62, 95% CI 0.52 to 4.99; 7 RCTs, 697 women; I² = 0%; low‐certainty evidence). This suggests that if the rate of bladder injury during abdominal hysterectomy is assumed to be 1%, then during vaginal hysterectomy it would be 1% to 3%. Similarly, we are uncertain whether there is a difference in ureter injury (OR 3.10, 95% CI 0.12 to 79.23; 3 RCTs, 277 women; I² = n/a; very low‐certainty evidence). The pooled outcome of urinary tract injuries after vaginal versus abdominal hysterectomy did not show a clear difference or equivalence between one route and the other (OR 1.73, 95% CI 0.65 to 4.63; 9 RCTs, 901 women; I² = 0%) (Analysis 1.3).

1.3. Analysis.

Comparison 1: VH versus AH, Outcome 3: Intraoperative visceral injury (dichotomous)

Four studies reported no bowel injuries (among 479 women). Among two studies (219 women) one vascular injury was reported in the AH group (OR 0.33, 95% CI 0.01 to 8.21; I² = n/a).

1.4 Major long‐term complications

Based on two studies, we are uncertain whether there is a difference in urinary dysfunction between groups (OR 3.20, 95% CI 0.32 to 31.90; 2 RCTs, 177 women; I² = n/a) (Analysis 1.4).

1.4. Analysis.

Comparison 1: VH versus AH, Outcome 4: Long‐term complications (dichotomous)

Sexual function was reported by Ekanayake 2020 using the International Consultation on Incontinence Questionnaire Vaginal Symptoms (ICIQ-VS) Module. They found improvements in vaginal symptoms at six months and one year following both VH and AH, with no difference in improvement between the two groups (Analysis 1.8).

Fistula formation, pelvic‐abdominal pain, bowel dysfunction and pelvic floor condition (prolapse) were not reported on.

Secondary outcomes

1.5 Operation time

We are uncertain whether there is a difference in operative time between VH and AH, with five trials favouring vaginal and two favouring abdominal hysterectomy (mean difference (MD) ‐19.02 minutes, 95% CI ‐46.80 to 8.75; 7 RCTs, 594 women; I² = 99%) (Analysis 1.5). The heterogeneity for this comparison is very high and could not be fully explained through our sensitivity analysis. Surgeon experience is likely to play a role but is not sufficiently well described in the studies to be fully evaluated.

1.5. Analysis.

Comparison 1: VH versus AH, Outcome 5: Operation time (mins)

Five trials reported descriptive data on operation times for this comparison. Ekanayake 2021 reported a median operation time for VH of 50 minutes (range 35 to 65 minutes) versus 45 minutes for AH (range 36.5 to 60 minutes). The trial Hwang 2002 also reported data as a median and range and found a shorter median operating time for VH (74 minutes, range 40 to 120) versus AH (98 minutes, range 85 to 150). Miskry 2003 reported mean and range (VH 68.8 minutes (30 to 180) versus AH 68.2 minutes (45 to 174)). Nanavati 2016 and Ribeiro 2003 reported means only (VH 77.5, 78 minutes respectively versus AH 75, 109 minutes respectively) (Analysis 1.8).

1.6 (Sequelae of) bleeding

We are uncertain whether there is a difference between the groups in the need for blood transfusion (OR 0.78, 95% CI 0.44 to 1.38; 9 RCTs, 852 women; I² = 15%) and occurrence of pelvic haematoma (OR 1.11, 95% CI 0.45 to 2.78; 7 RCTs, 694 women; I² = 0%) (Analysis 1.6).

1.6. Analysis.

Comparison 1: VH versus AH, Outcome 6: Short‐term outcomes (dichotomous)

1.7 Short‐term outcomes and complications

Hospital stay may be slightly shorter after vaginal hysterectomy compared to abdominal hysterectomy (MD ‐1.57 days, 95% CI ‐2.11 to ‐1.03; 7 RCTs, 570 women; I² = 96%) (Analysis 1.7). Heterogeneity for this comparison was very high and, again, not explained by our sensitivity analysis. Differences between studies are likely explained in part by changes in practice over time (with newer studies favouring earlier discharge) and institutional differences, though the information needed to fully explore this hypothesis was lacking. An additional five studies reported descriptive data on hospital stay that also favoured a shorter hospital stay with VH compared to AH (Analysis 1.8) (Allam 2015; Ekanayake 2021; Hwang 2002; Nanavati 2016; Ribeiro 2003).

1.7. Analysis.

Comparison 1: VH versus AH, Outcome 7: Length of hospital stay (days)

Vaginal cuff infection may be more likely after VH than AH, but the analysis was underpowered and we cannot be certain (OR 3.14, 95% CI 0.48 to 20.55; 3 RCTs, 216 women; I² = 0%; low‐certainty evidence). This suggests that if the rate of vaginal cuff infection following abdominal hysterectomy is assumed to be 1%, then following vaginal hysterectomy it would be 0% to 16%.

Wound/abdominal wall infection was probably less likely after VH compared to AH (OR 0.18, 95% CI 0.06 to 0.53; 6 RCTs, 628 women; I² = 0%; moderate‐certainty evidence) (Analysis 1.6). This suggests that if the rate of wound/abdominal wall infection following abdominal hysterectomy is assumed to be 6%, then following vaginal hysterectomy it would be 0% to 3%.

We are uncertain whether there is a difference in urinary tract infection between the two groups (OR 0.52, 95% CI 0.14 to 1.97; 5 RCTs, 350 women; I² = 0%).

The numbers of women included in studies that reported on chest infection (OR 1.00, 95% CI 0.13 to 7.60; 1 RCT, 60 women; I² = n/a) were too low to make meaningful comparisons.

Febrile episodes or unspecified infections may be reduced by an uncertain amount with VH compared to AH (OR 0.59, 95% CI 0.35 to 1.01; 6 RCTs, 593 women; I² = 6%; moderate‐certainty evidence). This suggests that if the rate of febrile episodes following abdominal hysterectomy is assumed to be 13%, then following vaginal hysterectomy it would be 5% to 13%.

There were no thromboembolisms in either group when reported in two RCTs (219 women) (Analysis 1.6).

1.8 Postoperative ileus

No study in this comparison reported on this outcome.

1.9 Wound dehiscence

There were three cases of wound dehiscence reported, all occurring after abdominal hysterectomy (2 RCTs, 218 women; Benassi 2002; Nanavati 2016).

1.10 Cost

Two studies reported on cost of the procedure (Analysis 1.8). Ekanayake 2021 reported the average cost of VH in US dollars (USD) as USD 800 (95% CI 622 to 1116) and that of AH as USD 659 (95% CI 632 to 687). Benassi 2002 reported an average cost of VH of $58,581 and AH of $71,882. The currency being reported is unclear, although the study is from Parma, Italy. The authors explain the increased AH cost as primarily attributable to increased length of hospital stay.

2 Laparoscopic hysterectomy (LH) versus abdominal hysterectomy (AH)

Primary outcomes

2.1 Return to normal activities

Return to normal activities may be quicker after laparoscopic‐assisted vaginal hysterectomy (LAVH) than after AH (MD ‐12.20 days, 95% CI ‐18.55 to ‐5.86; 3 RCTs, 288 women; I² = 82%) and may be quicker after total laparoscopic hysterectomy (TLH) than after AH (MD ‐14.33 days, 95% CI ‐17.92 to ‐10.75; 4 RCTs, 330 women; I² = 39%). Similarly, when different routes of laparoscopic hysterectomy were combined, the return to normal activities was likely faster than after AH (MD ‐13.01 days, 95% CI ‐16.47 to ‐9.56; 7 RCTs, 618 women; I² = 68%; low‐certainty evidence) (Analysis 2.1). This suggests that if the return to normal activities after abdominal hysterectomy is assumed to be 37 days, then after laparoscopic hysterectomy it would be between 22 and 25 days. One study reported only the mean days (Schütz 2002). For three additional RCTs the data could not be pooled. Median duration of return to normal activities was shorter for LH in these three trials (Langebrekke 1996; Persson 2006; Raju 1994).

2.1. Analysis.

Comparison 2: LH versus AH, Outcome 1: Return to normal activities (days)

2.2 Satisfaction and quality of life

We are uncertain whether there is a difference in patient satisfaction between LH and AH (OR 0.65, 95% CI 0.32 to 1.30; 1 RCT, 166 women; I² = n/a; very low‐certainty evidence) (Lumsden 2000) (Analysis 2.2). This suggests that in women with a 78% satisfaction rate after abdominal hysterectomy, the satisfaction rate after laparoscopic hysterectomy would be between 53% and 82%.

2.2. Analysis.

Comparison 2: LH versus AH, Outcome 2: Satisfaction

For LH versus AH, Garry 2004 demonstrated that quality of life (measured by the SF12 scoring system) was better for LH at six weeks; body image was improved for LH versus AH at six weeks, but not at four and 12 months; and sexual frequency was higher at six weeks following LH. Kluivers 2007 found a treatment effect favouring LH in the RAND‐36 scale for vitality in the first 12 weeks postoperatively. In the long‐term follow‐up (four years) of Kluivers 2007, Nieboer 2012 found that the total RAND‐36 score favoured LH, as well as the RAND‐36 sub‐scale scores for vitality, physical functioning and social functioning. Lumsden 2000 used the EuroQol 5D thermometer, and there was no evidence of a difference at one month, six months or one year after surgery. Olsson 1996 asked the patients six to eight weeks after surgery whether the duration of postoperative hospital stay had been adequate and 9% (LH) versus 17% (AH) of patients reported that the stay had been too short. Persson 2006 applied four psychometric tests, but there was no evidence of a difference between the interventions in the first six months after surgery (Analysis 2.23).

2.23. Analysis.

Comparison 2: LH versus AH, Outcome 23: Long‐term outcomes: quality of life (descriptive data)

Long‐term outcomes: quality of life (descriptive data)
Study	Description	LH	AH	Comments
Garry 2004	Questionnaire assessment of sexual activity, body image (BIS) and health status (SF‐12) before and after surgery (6 weeks, 4 months and 1 year) SF‐12 scores: difference at each time point (high score = better quality of life) Body Image Scale: difference at each time point (low score = a better body image)	SF scores PHYSICAL COMPONENT SUMMARY (PCS‐12) Baseline (n = 447) Mean = 44.9, SD = 11.7 6 weeks (n = 301) Mean = 46.8, SD = 10.1 4 months (n = 304) Mean = 52.6, SD = 8.6 1 year (n = 330) Mean = 53.6, SD = 8.4 MENTAL COMPONENT SUMMARY (MCS‐12) Baseline (n = 447 Mean = 45.8, SD = 11.7 6 weeks (n = 301) Mean = 50, SD = 11.4 4 months (n = 304) Mean = 50.9, SD = 10.5 1 year (n = 330) Mean = 50.7, SD = 10.7 Body Image Scale Baseline (n = 540) Mean = 8.8, SD = 8.1 6 weeks (n = 357) Mean = 3.7, SD = 4.9 4 months (n = 346) Mean = 3.3, SD = 4.9 1 year (n = 387) Mean = 3.4, SD = 5.2	SF scores PHYSICAL COMPONENT SUMMARY (PCS‐12) Baseline (n = 221) Mean = 45.6, SD = 11.5 6 weeks (n = 148) Mean = 41.7, SD = 9.7 4 months (n = 134) Mean = 51.6, SD = 8.6 1 year (n = 148) Mean = 52.7, SD = 9.3 MENTAL COMPONENT SUMMARY (MCS‐12) Baseline (n = 221) Mean = 45.3, SD = 11.3 6 weeks (n = 148) Mean = 51.9, SD = 10.8 4 months (n = 134) Mean = 51.8, SD = 9.5 1 year (n = 148) Mean = 51.9, SD = 10.2 Body Image Scale Baseline (n = 270) Mean = 9, SD = 7.9 6 weeks (n = 172) Mean = 5.2, SD = 5.9 4 months (n = 159) Mean = 4.4, SD = 6.3 1 year (n = 168) Mean = 4.1, SD = 5.7	SF scores PCS‐12 Baseline: difference (CI) = 0.6 (‐1.2 to 2.5) 6 weeks: difference (CI) = ‐5.1 (‐7.1 to ‐3.2); P value < 0.0001 4 months: difference (CI) = ‐1.0 (‐2.8 to 0.7); P value = 0.25 1 year = difference in (CI) = ‐0.9 (‐2.5 to 0.8); P value = 0.32 MCS‐12 Baseline: difference (CI) = ‐0.5 (‐2.4 to 1.4) 6 weeks: difference (CI) = 1.8 (‐0.4 to 4); P value = 0.11 4 months: difference (CI) = 0.8 (‐1.3 to 2.9); P value = 0.44 1 year: difference (CI) = 1.1 (‐0.9 to 3.2); P value = 0.27 Body Image Scale Baseline: difference (CI) = 0.2 (‐0.9 to 1.4) 6 weeks: difference (CI) = 1.5 (0.5 to 2.4); P value = 0.005 4 months: difference (CI) = 1.1 (0.06 to 2.1); P value = 0.06 1 year: difference (CI) = 0.7 (‐0.2 to 1.7); P value = 0.13 Both LH and AH groups had improvements in the Physical and Mental components of the SF‐12 and Body Image Scale (BIS). These were maintained and improved at 12 months. Significant difference in PCS‐12 at 6 weeks between LH and AH and highly significant difference in BIS at 6 weeks, but this difference did not persist at 4 and 12 months.
Kluivers 2007	Questionnaire RAND‐36. A high score is a better quality of life. Statistical analysis with use of linear mixed model to evaluate the differences between 2 and 12 weeks while accounting for baseline value In Nieboer 2012, the same patients were evaluated with use of the same questionnaire 4 years after surgery	n = 27 at baseline n = 27, 26, 26, 25 and 22 at 1, 2, 4, 6 and 12 weeks respectively n = 23 at 4 years	n = 32 at baseline n = 32, 32, 32, 31, 30 and 30 at 1, 2, 4, 6 and 12 weeks respectively n = 26 at 4 years	Difference (95% CI) in favour of LH (the score range on subscales is 100; the score range on total RAND‐36 scales is 800) over the first 12 weeks: Physical functioning 7.8 (‐0.3 to 15.9) Social functioning 7.0 (‐1.8 to 15.7) Role physical 1.7 (‐7.7 to 11.1) Role emotional 1.5 (‐13.4 to 16.5) Mental health 3.6 (‐2.8 to 9.9) Vitality 12.0 (4.7 to 19.3) Bodily pain 8.4 (‐0.1 to 17.4) General health 0.0 (‐8.1 to 8.1) Total RAND‐36 49.6 (‐5.1 to 104.2) Only the difference in the subscale vitality was statistically significant Analysis over 4 years follow‐up after surgery: total RAND‐36 scores overall mean difference 50.4 points (95% CI 1.0 to 99.7) in favour of LH. Statistically significant higher scores were also found on the domains physical role functioning, social role functioning and vitality
Lumsden 2000	EuroQol Health Questionnaire used to measure women's evaluation of their health state post surgery (1, 6 and 12 months after surgery). Use of a visual analogue thermometer (0 is worst imaginable health state and 100 is best imaginable health state).	1 month (post‐op minus pre‐op): n = 74. Mean = 7, SD = 24.1. Median = 10, range (‐50 to 50) 6 months: n = 62. Mean = 11.3, SD = 23.9. Median = 15, range (‐50 to 60) 1 year: n = 43. Mean = 12.6, SD = 25. Median = 14, range (‐40 to 73)	1 month: n = 76. Mean = 6.8, SD = 19.2. Median = 8, range (‐50 to 60). 6 months: n = 61. Mean = 14.9, SD = 16.7 Median = 15, range (‐20 to 60) 1 year: n = 47. Mean = 15.9, SD = 21. Median = 15, range (‐40 to 60)	Mean difference: 1 month: ‐1.6 (‐7.2 to 6.9) 6 months: 3.7 (‐3.7 to 11) 1 year: 4.9 (‐6.7 to 12.8) No evidence of a significant difference at 1 month, 6 months or 1 year after surgery
Olsson 1996	6 to 8 weeks after surgery participants were asked in an anonymous questionnaire if they considered the duration of their postoperative stay adequate	9% of women in the LAVH group considered their time in hospital following surgery to be too short	17% of women in the AH group considered their time in hospital following surgery to be too short	—
Persson 2006	Questionnaires: Psychological General Wellbeing (PGWI), Women Health Questionnaire (WHQ), Spielberger Trait Anxiety Inventory (STAI) and Beck's Depression Inventory (BDI) A higher score in the PGWB shows a higher degree of wellbeing, whereas in the WHQ, STAI and BDI a higher score shows the more undesirable outcomes. Assessment at baseline, and 5 weeks and 6 months postoperatively. Statistical analysis with the use of ANOVA for repeated measurements Persson 2008 analysed wellbeing on a 0 to 100 VAS and stress coping ability	n = 63 PGWB: Baseline: mean = 96.7, SD = 17.9. 5 weeks: mean = 100.4, SD = 16.7. 6 months: mean = 104.7, SD = 18.5 WHQ: Baseline: mean = 64.9, SD = 13.9. 5 weeks: mean = 54.6, SD = 12.8. 6 months: mean = 55.0, SD = 14.4. STAI: Baseline: mean = 35.6, SD = 9.1. 5 weeks: mean = 32.7, SD = 8.7. 6 months: mean = 33.6, SD = 10.2. BDI: Baseline: mean = 6.6, SD = 5.8. 5 weeks: mean = 4.6, SD = 5.5. 6 months: mean = 5.3, SD = 6.8	n = 56 PGWB: Baseline: mean = 96.5, SD = 16.5. 5 weeks: mean = 102.1, SD = 16.4. 6 months: mean = 106.1, SD = 16.0 WHQ: Baseline: mean = 63.9, SD = 18.2. 5 weeks: mean = 54.3, SD = 17.1. 6 months: mean = 54.2, SD = 17.2 STAI: Baseline: mean = 34.7, SD = 10.1. 5 weeks: mean = 31.7, SD = 10.6. 6 months: mean = 31.7, SD = 9.2 BDI: Baseline: mean = 6.9, SD = 6.1. 5 weeks: mean = 5.0, SD = 6.5. 6 months: mean = 4.0, SD = 5.2	Main effect between groups: PGWB P value = 0.719, WHQ P value = 0.800, STAI P value = 0.418, BDI P value = 0.788. Main effect over time: PGWB P value < 0.0001, WHQ P value < 0.0001, STAI P value = 0.0002, BDI P value = 0.0002 Interaction: PGWB P value = 0.772, WHQ P value = 0.953, STAI P value = 0.762, BDI P value = 0.223 In Persson 2008: no significant difference was found in the day‐by‐day recovery of general wellbeing between the operating methods. Stress coping ability did significantly influence the day‐by‐day recovery of general wellbeing

2.3 Intraoperative visceral injury

We are uncertain whether there is a difference in the risk of bladder injury between LAVH and AH (OR 1.70, 95% CI 0.49 to 5.88; 6 RCTs, 723 women; I² = 0%) or TLH and AH (OR 0.54, 95% CI 0.13 to 2.19; 5 RCTs, 359 women; I² = 0%). When studies involving non‐categorisable LH were compared to AH, bladder injury was probably more likely in the LH group (OR 2.87, 95% CI 1.02 to 8.07; 4 RCTs, 1216 women; I² = 0%). When all LH types are pooled and compared to AH, we are uncertain whether there is a difference (OR 1.68, 95% CI 0.88 to 3.22; 15 RCTs, 2298 women; I² = 0%; low‐certainty evidence) (Analysis 2.3). This suggests that if the rate of bladder injury during abdominal hysterectomy is assumed to be 1%, then during laparoscopic hysterectomy it would be 1% to 3%.

2.3. Analysis.

Comparison 2: LH versus AH, Outcome 3: Bladder injury

When LH groups were pooled and compared to AH, rates of ureteral injury were probably higher in the LH group (OR 3.62, 95% CI 1.18 to 11.11; 10 RCTs, 1675 women; I² = 0%; moderate‐certainty evidence) (Analysis 2.4) (Figure 4). This suggests that if the rate of ureter injury during abdominal hysterectomy is assumed to be 0%, then during laparoscopic hysterectomy it would be 0% to 2%.

2.4. Analysis.

Comparison 2: LH versus AH, Outcome 4: Ureter injury

4.

Similarly, when we pooled bladder and ureter injuries together as 'urinary tract injury', these were probably more likely with LH than AH (OR 2.16, 95% CI 1.19 to 3.93; 18 RCTs, 2594 women; I² = 0%) (Analysis 2.5).

2.5. Analysis.

Comparison 2: LH versus AH, Outcome 5: Urinary tract (bladder or ureter) injury

We are uncertain whether there is a difference in bowel injury rates between LH and AH (OR 0.23, 95% CI 0.05 to 1.14; 7 RCTs, 1431 women; I² = 0%) (Analysis 2.6).

2.6. Analysis.

Comparison 2: LH versus AH, Outcome 6: Bowel injury

We are uncertain whether there is a difference in vascular injury rates between LH and AH (OR 1.40, 95% CI 0.48 to 4.09; 3 RCTs, 1056 women; I² = 0%) (Analysis 2.7).

2.7. Analysis.

Comparison 2: LH versus AH, Outcome 7: Vascular injury

2.4 Major long‐term complications

Comparisons of long‐term complications were underpowered to be certain of a difference (fistula formation (OR 3.07, 95% CI 0.32 to 29.96; 2 RCTs, 245 women; I² = 0%) (Analysis 2.8) and urinary dysfunction (OR 0.94, 95% CI 0.49 to 1.82; 3 RCTs, 343 women; I² = 0%) (Analysis 2.9)).

2.8. Analysis.

Comparison 2: LH versus AH, Outcome 8: Fistula

2.9. Analysis.

Comparison 2: LH versus AH, Outcome 9: Urinary dysfunction

Ekanayake 2020 evaluated urinary and sexual function before and after surgery using the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) Modules and ICIQ‐VS questionnaires. They found improvements in vaginal symptoms, urinary flow symptoms, urinary voiding symptoms and urinary incontinence symptoms at six months and one year following both VH and AH with no difference in improvement between the two groups (Analysis 2.27).

2.27. Analysis.

Comparison 2: LH versus AH, Outcome 27: Urinary and sexual dysfunction (descriptive data)

Urinary and sexual dysfunction (descriptive data)
Study	Description	LH	AH	Conclusion
Ekanayake 2020	Questionnaire ICIQ‐VS. Vaginal symptoms pre‐operatively, 6 months and 1 year postoperatively. A high score means experiencing more vaginal symptoms	Pre‐operatively: n = 49 median = 4 IQR (2 to 10.5) 6 months postoperatively: n = 48 median = 3 IQR (0 to 6) 1 year postoperatively: n = 47 median = 4 IQR (0 to 10)	Pre‐operatively: n = 49 median = 6 IQR (2 to 8) 6 months postoperatively: n = 49 median = 4 IQR (0 to 8) 1 year postoperatively: n = 47 median = 4 IQR (0 to 8)	For both the TAH and TLH group vaginal function domain scores at 6 months and 1 year postoperatively were statistically significant compared to the respective pre‐operative scores (P < 0.001)
Ekanayake 2020	Questionnaire ICIQ‐LUTS. Urinary symptoms pre‐operatively, 6 months and 1 year post‐operatively. A high score means experiencing more urinary symptoms	Urinary flow symptoms: Pre‐op: n = 49 median = 1 IQR (1 to 4) 6 months postop: n = 48 median = 1 IQR (0 to 3) 1 year postop: n = 47 median = 1 IQR (0 to 3) Urinary voiding symptoms: Pre‐op: n = 49 median = 0 IQR (0 to 0) 6 months postop: n = 48 median = 0 IQR (0 to 0) 1 year postop: n = 47 median = 0 IQR (0 to 0) Urinary incontinence symptoms: Pre‐op: n = 49 median = 0 IQR (0 to 3) 6 months postop: n = 48 median = 0 IQR (0 to 1.75) 1 year postop: n = 47 median = 0 IQR (0 to 2)	Urinary flow symptoms: Pre‐op: n = 49 median = 2 IQR (1 to 4) 6 months postop: n = 49 median = 1 IQR (0 to 3) 1 year postop: n = 47 median = 1 IQR (0 to 3) Urinary voiding symptoms: Pre‐op: n = 49 median = 0 IQR (0 to 0) 6 months postop: n = 49 median = 0 IQR (0 to 0) 1 year postop: n = 47 median = 0 IQR (0 to 0) Urinary incontinence symptoms: Pre‐op: n = 49 median = 0 IQR (0 to 2) 6 months postop: n = 49 median = 0 IQR (0 to 2) 1 year postop: n = 47 median = 0 IQR (0 to 2)	Urinary flow symptoms: TLH 6 months postoperative score versus pre‐operative score: P < 0.01 TLH 1 year postoperative score versus pre‐operative score: P < 0.05 TAH 6 months postoperative score versus pre‐operative score: P < 0.001 TAH 1 year postoperative score versus pre‐operative score: P < 0.001 Urinary voiding symptoms: TLH 6 months postoperative score versus pre‐operative score: P = 0.47 TLH 1 year postoperative score versus pre‐operative score: P < 0.05 TAH 6 months postoperative score versus pre‐operative score: P = 0.47 TAH 1 year postoperative score versus pre‐operative score: P = 0.20 Urinary incontinence symptoms: TLH 6 months postoperative score versus pre‐operative score: P = 0.21 TLH 1 year postoperative score versus pre‐operative score: P < 0.05 TAH 6 months postoperative score versus pre‐operative score: P = 0.06 TAH 1 year postoperative score versus pre‐operative score: P < 0.01
Ekanayake 2020	Questionnaire ICIQ‐VS. Sexual symptoms pre‐operatively, 6 months and 1 year postoperatively. A high score means experiencing more sexual symptoms	Pre‐operatively: n = 49 median = 0 IQR (0 to 0) 6 months postoperatively: n = 23 median = 0 IQR (0 to 0) 1 year postoperatively: n = 22 median = 0 IQR (0 to 4.2)	Pre‐operatively: n = 49 median = 0 IQR (0 to 11.5) 6 months postoperatively: n = 23 median = 0 IQR (0 to 10) 1 year postoperatively: n = 22 median = 0 IQR (0 to 14)	TLH group: 6 months postoperative score versus pre‐operative score: P = 0.06 1 year postoperative score versus pre‐operative score: P < 0.05 TAH group: 6 months postoperative score versus pre‐operative score: P < 0.05 1 year postoperative score versus pre‐operative score: P = 0.08

Pelvic‐abdominal pain, bowel dysfunction and pelvic floor condition were not reported on for this comparison.

Secondary outcomes

2.5 Operation time

We are uncertain whether there is a difference in operation time between LAVH versus AH (MD 23.16 minutes, 95% CI ‐4.04 to 50.35; 9 RCTs, 910 women; I² = 99%) (Analysis 2.10). Other subcategories of laparoscopic hysterectomy (non‐categorisable LH and total laparoscopic hysterectomy (TLH)) probably took slightly longer than abdominal hysterectomies (non‐categorisable LH versus AH: MD 14.80 minutes, 95% CI 7.36 to 22.24; 1 RCT, 100 women; I² = n/a ; TLH versus AH: MD 19.75, 95% CI 7.94 to 31.55; 5 RCTs, 393 women; I² = 81%) (Analysis 2.10). Heterogeneity for these comparisons was overall high and largely isolated to the LAVH versus AH comparison. This could not be explained by our sensitivity analysis and perhaps relates to variation in technique and surgeon experience within the LAVH sub‐category.

2.10. Analysis.

Comparison 2: LH versus AH, Outcome 10: Operation time (mins)

Thirteen additional trials could not be pooled because of the descriptive format in which the data were presented. Except for Yuen 1998, in all of these trials abdominal hysterectomy was associated with a shorter median operation time (Ekanayake 2021; Falcone 1999; Ferrari 2000; Garry 2004, Hwang 2002; Langebrekke 1996; Muzii 2007; Nanavati 2016; Persson 2006; Raju 1994, Ribeiro 2003; Schütz 2002) (Analysis 2.24).

2.24. Analysis.

Comparison 2: LH versus AH, Outcome 24: Operation time (descriptive data)

Operation time (descriptive data)
Study	LH	AH	Comments
Ekanayake 2021	n = 49 median = 93 mins IQR (80 to 111)	n = 49 median = 45 mins IQR (36.5 to 60)	TLH vs TAH Not tested separately
Falcone 1999	n = 23 median = 180 mins range (139 to 225)	n = 21 median = 130 mins range (97 to 155)	TLH vs AH Wilcoxon rank‐sum test P value < 0.001
Ferrari 2000	n = 31 median = 135 mins range (115 to 173)	n = 31 median = 120 mins range (98 to 123)	LAVH vs AH P value = 0.001 Calculated from the first incision to closure of all wounds
Garry 2004	n = 584 median = 84 mins range(10 to 325)	n = 292 median = 50 mins range (19 to 155)	non‐categorisable LH vs AH Calculated from first incision to last suture
Hwang 2002	With 2nd procedure n = 13 median = 119 range (80 to 165) Without 2nd procedure n = 17 median = 109 mins range (85 to 175)	With 2nd procedure n = 8 median = 117 mins range (90 to 190) Without 2nd procedure n = 22 median = 98 range (85 to 150)	TLH vs AH Not tested separately
Langebrekke 1996	n = 46 median = 100 mins range (50 to 153)	n = 54 median = 60.5 mins range (22 to 105)	TLH vs AH
Muzii 2007	n = 40 median = 86 mins range (60 to 120)	n = 41 median = 58 mins range (45 to 75)	LAVH vs minilaparotomy AH
Nanavati 2016	n =50 mean 108 mins no IQR/SD given	n = 50 mean 75 mins no IQR/SD given	No IQR/SD given, no P value
Persson 2006	n = 63 median = 99 mins range (50 to 190)	n = 56 median = 64 mins range (35 to 150)	LAVH vs AH P value < 0.0001 (students t test)
Raju 1994	n = 40 median = 100 mins range (61 to 180)	n = 40 median = 57 mins range (25 to 151)	LAVH vs AH P value < 0.0001 Mann‐Whitney U test Calculated from first incision to time all wounds were closed, dressed and urinary catheter inserted
Ribeiro 2003	n = 20 Mean 119 mins (no measure of spread reported)	n = 20 Mean 109 mins (no measure of spread reported)	TLH vs AH
Schütz 2002	n = 28 median = 133 mins range (120 to 160)	n = 20 median = 132 mins range (121 to 145)	LAVH vs AH
Yuen 1998	n = 20 median = 95 mins range (79 to 143)	n = 24 median = 105 mins range (86 to 120)	LAVH vs AH Calculated from first surgical incision to time of last suture

2.6 (Sequelae of) bleeding

We are uncertain whether there is a difference in the number of women with substantial bleeding between laparoscopic and abdominal hysterectomy (OR 0.46, 95% CI 0.19 to 1.10; 6 RCTs, 1366 women; I² = 0%) (Analysis 2.11).

2.11. Analysis.

Comparison 2: LH versus AH, Outcome 11: Bleeding

Overall, laparoscopic hysterectomy was probably associated with a lower likelihood of blood transfusion (OR 0.58, 95% CI 0.34 to 0.99; 23 RCTs, 2911 women; I² = 27%) (Analysis 2.12).

2.12. Analysis.

Comparison 2: LH versus AH, Outcome 12: Transfusion

We are uncertain whether there is a difference in rates of pelvic haematoma following laparoscopic versus abdominal hysterectomy (OR 0.69, 95% CI 0.36 to 1.33; 10 RCTs, 938 women; I² = 0%) (Analysis 2.13).

2.13. Analysis.

Comparison 2: LH versus AH, Outcome 13: Pelvic haematoma

2.7 Short‐term outcomes and complications

Hospital stay may be shorter in all LH subcategories compared to AH (LAVH versus AH (MD ‐2.39 days, 95% CI ‐3.20 to ‐1.59; 8 RCTs, 870 women; I² = 97%), TLH versus AH (MD ‐2.07 days, 95% CI ‐3.29 to ‐0.84; 4 RCTs, 333 women; I² = 96%)) (Analysis 2.14). There was high heterogeneity for these comparisons, which was not explained by subcategory of LH or sensitivity analysis. We suspect that variation in practice over time and regional differences in practice play a role, but we did not have enough information to fully evaluate these relationships. Additionally, the funnel plot for this outcome did suggest possible small study bias (Figure 5).

2.14. Analysis.

Comparison 2: LH versus AH, Outcome 14: Length of hospital stay (days)

5.

Funnel plot for length of hospital stay for laparoscopic hysterectomy versus abdominal hysterectomy comparision.

Data from 14 trials on hospital stay could not be included in the meta‐analysis, because of the presentation of median numbers instead of means. In all of these trials, median duration of hospital stay was shorter for the LH versus AH group. There was evidence of a difference in seven trials (Allam 2015; Falcone 1999; Ferrari 2000; Langebrekke 1996; Persson 2006; Raju 1994; Yuen 1998), whereas in one study there was unclear evidence of a difference (Muzii 2007). In the other six trials no statistical testing was applied (Analysis 2.25).

2.25. Analysis.

Comparison 2: LH versus AH, Outcome 25: Length of hospital stay (descriptive data)

Length of hospital stay (descriptive data)
Study	LH	AH	Comments
Allam 2015	n = 30 median 0.75 days IQR (0.5 to1.5)	n = 30 median 1.5 days IQR (1 to 2)	P value < 0.001 Kruskal–Wallis test
Ekanayake 2021	n = 49 median = 2 days IQR (1 to 3)	n = 49 median = 3 days IQR (2 to 3)	TLH vs TAH Not tested separately
Falcone 1999	n = 23 median = 1.5 days range (1.0 to 2.3)	n = 21 median = 2.5 days range (1.5 to 2.5)	P value = 0.038 Wilcoxon rank‐sum test
Ferrari 2000	n = 31 median = 3.8 days range (3.8 to 4.0)	n = 31 median = 5.8 days range (5.3 to 6.3)	P value < 0.001
Garry 2004	n = 584 median = 3 days range (1 to 36)	n = 292 median = 4 days range (1 to 36)	—
Hwang 2002	n = 30 median = 4.7 days range (3 to 7)	n = 30 median = 5 days range (4 to 8)	Not tested separately
Langebrekke 1996	n = 46 median = 2 days range (0 to 5)	n = 54 median = 5 days range (3 to 12)	P value < 0.001 Wilcoxon rank‐sum test
Muzii 2007	n = 40 median = 2 days range (1 to 3)	n = 41 median = 3 days range = (1 to 5)	P value = 0.53
Nanavati 2016	n = 50 mean 4.5 no IQR/SD given	n = 50 mean 6 no IQR/SD given	No IQR/SD given no P value
Persson 2006	n = 63 median = 2 days range (1 to 11)	n = 56 median = 3 days range (2 to 7)	P value = 0.0006 In the same population (described in Persson 2008), duration of sick leave was associated with the occurrence of postoperative complications but not with stress‐coping ability
Raju 1994	n = 40 median = 3.5 days range (1 to 6)	n = 40 median = 6 days range (3 to 13)	P value < 0.0001 Mann‐Whitney U test
Ribeiro 2003	n = 20 all home on day 2	n = 20 all home on day 3	—
Schütz 2002	n = 28 median = 6.5 days range (5 to 7)	n = 20 median = 10 days range (8.25 to 11)	—
Yuen 1998	n = 20 median = 4 days range (4 to 5)	n = 24 median = 6 days range (5 to 9)	P value < 0.001 Mann‐Whitney U test

We are uncertain whether there is a difference in the occurrence of vaginal cuff infection (OR 1.43, 95% CI 0.67 to 3.04; 9 RCTs, 852 women; I² = 0%; low‐certainty evidence) (Analysis 2.15). This suggests that if the rate of vaginal cuff infection following abdominal hysterectomy is assumed to be 2%, then following laparoscopic hysterectomy it would be 2% to 7%.

2.15. Analysis.

Comparison 2: LH versus AH, Outcome 15: Vaginal cuff infection

There were probably fewer wound or abdominal wall infections in laparoscopic hysterectomy (OR 0.21, 95% CI 0.10 to 0.45; 9 RCTs, 824 women; I² = 1%; moderate‐certainty evidence) (Analysis 2.16). This suggests that if the rate of wound/abdominal wall infection following abdominal hysterectomy is assumed to be 8%, then following laparoscopic hysterectomy it would be 1% to 4%.

2.16. Analysis.

Comparison 2: LH versus AH, Outcome 16: Wound/abdominal wall infection

We are uncertain whether there is a difference in urinary tract infections (OR 1.15, 95% CI 0.61 to 2.16; 9 RCTs, 757 women; I² = 0%) (Analysis 2.17).

2.17. Analysis.

Comparison 2: LH versus AH, Outcome 17: Urinary tract infection

There were probably fewer febrile episodes or unspecified infections (OR 0.65, 95% CI 0.49 to 0.85; 18 RCTs, 2386 women; I² = 26%; moderate‐certainty evidence) (Analysis 2.19). This suggests that if the rate of febrile episodes following abdominal hysterectomy is assumed to be 12%, then following laparoscopic hysterectomy it would be 7% to 11%. The difference was driven by the TLH versus AH and LAVH versus AH comparisons, which showed even lower ORs (than that of the combined outcome), whereas the non‐categorisable LH studies showed an unclear difference (OR 0.88, 95% CI 0.61 to 1.27; 4 RCTs, 1216 women; I² = 0%).

2.19. Analysis.

Comparison 2: LH versus AH, Outcome 19: Febrile episodes or unspecified infection

We are uncertain of a difference in chest infection (OR 0.31, 95% CI 0.07 to 1.35; 3 RCTs, 294 women; I² = 17%) (Analysis 2.18), and thromboembolic events (OR 1.10, 95% CI 0.33 to 3.71; 4 RCTs, 1225 women; I² = 0%) (Analysis 2.20).

2.18. Analysis.

Comparison 2: LH versus AH, Outcome 18: Chest infection

2.20. Analysis.

Comparison 2: LH versus AH, Outcome 20: Thromboembolism

2.8 Postoperative ileus

No study in this comparison reported on this outcome.

2.9 Wound dehiscence

Two studies reported on the occurrence of wound dehiscence (Muzii 2007; Nanavati 2016), and there was unclear evidence of a difference (OR 0.33, 95% CI 0.07 to 1.63; 2 RCTs, 181 women; I² = 65%) (Analysis 2.21).

2.21. Analysis.

Comparison 2: LH versus AH, Outcome 21: Wound dehiscence

2.10 Costs

Seven RCTs examined comparative cost in any detail (Ekanayake 2021; Ellstrom 1998; Garry 2004 (as published in Sculpher 2004); Falcone 1999; Lumsden 2000; Raju 1994; Summitt 1998). Ekanayake 2021 included in their analysis pre‐operative and operative costs, hospital stay and costs up to six months after surgery. They calculated a lower cost of TAH compared to TLH (mean difference 93 USD) (Analysis 2.26). In the other studies, the operation costs of LH were higher (Lumsden 2000 identifies disposable equipment as the source of this) and essentially offset by the increased hospital stay associated with AH, such that there was no overall difference in costs between the two routes of surgery (Analysis 2.26).

2.26. Analysis.

Comparison 2: LH versus AH, Outcome 26: Cost (descriptive data)

Cost (descriptive data)
Study	Description	LH	AH	Comments
Ekanayake 2021	Direct costs, which includes preoperative costs, operative costs, cost of hospital stay and costs up to 6 months after surgery Units of currency = US dollars (USD)	n = 49 Mean = 752 USD 95% CI (719 to 795)	n = 49 Mean = 659 USD 95% CI (632 to 687)	TLH vs TAH The direct cost of TAH was significantly lower compared to TLH
Ellstrom 1998	Analysis of cost over a period of 12 weeks, starting on the day the participant entered the hospital. Direct costs (hospital costs) and indirect costs (loss of production value) were analysed separately. Units of currency = Swedish crowns (SEK)	n = 38 Direct costs (average) = SEK 23,169 Indirect costs (average) = SEK 10,314	n = 38 Direct costs (average) = SEK 22,780. Indirect costs (average) = SEK 20,743.	The change in costs between LH and AH are negligible as approximately 50% of hospital costs are fixed costs
Falcone 1999	Hospital costs (amount a provider must pay for goods and services) were assessed through the hospital accounting system. The direct and indirect costs were calculated for each patient from 3 different components: operating room costs, anaesthesia costs and ward costs	n = 24 Difference in medians (LH‐AH): total hospital costs = USD 277 (CI ‐163 to 1097), P value = 0.21	n = 24 (see LH)	Total hospital costs were not significantly higher in the LH group than the AH group
Lumsden 2000	Single set of unit costs applied to each unit of resource to provide a NHS cost for each woman. 1997/98 prices	n = 95 Total cost (operation, inpatient stay and readmissions): median = GBP 2112, mean = GBP 2479 Cost excluding disposables: median = GBP 1740, mean = GBP 2173	n = 95 Total cost: median = GBP 1667, mean = GBP 1832. Cost excluding disposables: median = GBP 1667, mean = GBP 1832	AH had significantly lower total costs than LH, resulting principally from the difference in operation costs. When the cost of disposable equipment was removed, the difference was non‐significant
Raju 1994	Cost analysis of each type of procedure on the major points of difference between either operation: cost of disposable consumables and the comparative costs of postoperative lengths of stay in hospital	n = 40 Cost of operation (average) = GBP 225 Cost of mean length of stay including operation time and cost of disposable instruments = GBP 1260	n = 40 Cost of operation (average) = GBP 30 Cost of mean length of stay including operation time and cost of disposable instruments = GBP 1750	—
Summitt 1998	Hospital charges for both groups	n = 34 Mean = USD 8161, SD = 3600, range (3061 to 23,591). P value > 0.05	n = 31 Mean = USD 6974, SD = 2843, range (3183 to 16,086). P value > 0.05	Lack of a statistical difference in total hospital charges

3 Laparoscopic hysterectomy (LH) versus vaginal hysterectomy (VH)

Primary outcomes

3.1 Return to normal activities

Only three studies contributed data to the meta‐analysis on return to normal activities following LH versus VH (Ekanayake 2021; Hwang 2002; Ottosen 2000). There was unclear evidence of a difference (MD ‐1.06 days, 95% CI ‐4.18 to 2.05; 3 RCTs, 238 women; I² = 0%; low‐certainty evidence) (Figure 2; Analysis 3.1). This suggests that if the return to normal activities after vaginal hysterectomy is assumed to be 31 days, then after laparoscopic hysterectomy it would be between 27 and 33 days.

3.1. Analysis.

Comparison 3: LH versus VH, Outcome 1: Return to normal activities (days)

Data from three RCTs could not be included in the meta‐analysis because of their descriptive nature (Richardson 1995; Roy 2011; Roy 2012). These three trials did not clearly show either equivalence or a difference in return to normal activities between LH and VH (Analysis 3.21).

3.21. Analysis.

Comparison 3: LH versus VH, Outcome 21: Return to normal activities (descriptive data)

Return to normal activities (descriptive data)
Study	LH	VH	Comments
Ekanayake 2020	n= 49 median = 30 range = 25.5 to 45	n = 49 median = 32 range = 24.5 to 60
Richardson 1995	n = 22 mean = 23.1 days range (7 to 56)	n = 23 mean = 22.2 range (7 to 56)
Roy 2011	TLH: n = 30 median = 15 days min‐max = 7 to 30 days LAVH: n = 30 median = 20 days min‐max = 8 to 40 days	n = 30 median = 14 days min‐max = 7 to 25 days	P value = 0.7
Roy 2012	n = 10 median = 20 days min‐max = 10 to 30 days	n = 10 median = 16 days min‐max = 12 to 24 days	P value = 0.05

3.2 Satisfaction and quality of life

Roy 2011 showed that six months after surgery, patients were more satisfied after total laparoscopic hysterectomy and vaginal hysterectomy than those who underwent laparoscopic‐assisted vaginal hysterectomy (P value = 0.003). The satisfaction rate was similar between patients undergoing total laparoscopic hysterectomy and non‐descent vaginal hysterectomy (Analysis 3.22). The descriptive character of these data means that they could not be included in the meta‐analysis.

3.22. Analysis.

Comparison 3: LH versus VH, Outcome 22: Long‐term outcomes: quality of life (descriptive data)

Long‐term outcomes: quality of life (descriptive data)
Study	Description	LH	VH	Comment
Roy 2011	Patient satisfaction was evaluated using HRQOL (health‐related quality of life) questionnaire and SF‐12 (12‐item Short Form health survey) and follow‐up visits in outpatient clinic were done at 1, 3 and 6 months	TLH: n = 30 LAVH: n = 30	n = 30	After 6 months of surgery, there was significantly higher satisfaction rate among patients who underwent TLH and NDVH (non‐descent vaginal hysterectomy) than those who underwent LAVH (P value = 0.003). The satisfaction was similar between the TLH and NDVH group.

3.3 Intraoperative visceral injury

We are uncertain whether there is a difference in bladder injury (OR 0.93, 95% CI 0.37 to 2.33; 10 RCTs, 1237 women; I² = 0%; low‐certainty evidence) (Analysis 3.3). This suggests that if the rate of bladder injury during vaginal hysterectomy is assumed to be 1%, then during laparoscopic hysterectomy it would be 1% to 3%. We are also uncertain whether there is a difference in rates of ureter injury (OR 0.69, 95% CI 0.09 to 5.43; 4 RCTs, 846 women; I² = 0%; low‐certainty evidence) (Analysis 3.2). This suggests that if the rate of ureter injury during vaginal hysterectomy is assumed to be 0%, then during laparoscopic hysterectomy it would be 0% to 2%. When these two groups were combined into urinary tract injuries, we remained uncertain of a difference (OR 0.92, 95% CI 0.40 to 2.09; 13 RCTs, 1536 women; I² = 0%) (Analysis 3.4).

3.3. Analysis.

Comparison 3: LH versus VH, Outcome 3: Bladder injury

3.2. Analysis.

Comparison 3: LH versus VH, Outcome 2: Ureter injury

3.4. Analysis.

Comparison 3: LH versus VH, Outcome 4: Urinary tract (bladder or ureter) injury

We are uncertain whether there is a difference in bowel injury (OR 3.26, 95% CI 0.13 to 82.16; 5 RCTs, 986 women, I² = NA)(Analysis 3.5) or vascular injury (OR 1.58, 95% CI 0.48 to 5.27; 5 RCTs, 785 women; I² = 0%) (Analysis 3.6). Overall the power to detect a difference is low due to the low numbers of women and low event rates in either group.

3.5. Analysis.

Comparison 3: LH versus VH, Outcome 5: Bowel injury

3.6. Analysis.

Comparison 3: LH versus VH, Outcome 6: Vascular injury

3.4 Major long‐term complications

We are uncertain whether there is a difference in the following long‐term complications: fistula formation (OR 0.30, 95% CI 0.01 to 7.67; 1 RCT, 56 women; I² = n/a) (Analysis 3.7), and urinary dysfunction (OR 1.0, 95% CI 0.25 to 4.07; 3 RCTs, 248 women; I² = 0%) (Analysis 3.8).

3.7. Analysis.

Comparison 3: LH versus VH, Outcome 7: Fistula

3.8. Analysis.

Comparison 3: LH versus VH, Outcome 8: Urinary dysfunction

Ekanayake 2020 evaluated urinary and sexual function before and after surgery using the ICIQ‐FLUTS and ICIQ‐VS questionnaires. They found improvements in vaginal symptoms, urinary flow symptoms, urinary voiding symptoms and urinary incontinence symptoms at six months and one year following both VH and LH, with no clear superiority or equivalence between the two groups (Analysis 3.26).

3.26. Analysis.

Comparison 3: LH versus VH, Outcome 26: Urinary and sexual dysfunction (descriptive data)

Urinary and sexual dysfunction (descriptive data)
Study	Description	LH	VH	Conclusion
Ekanayake 2020	Questionnaire ICIQ‐VS. Sexual symptoms pre‐operatively, 6 months and 1 year postoperatively. A high score means experiencing more sexual symptoms	Pre‐operatively: n = 49 median = 0 IQR (0 to 0) 6 months postoperatively: n = 23 median = 0 IQR (0 to 0) 1 year postoperatively: n = 22 median = 0 IQR (0 to 4.2)	Pre‐operatively: n = 49 median = 0 IQR (0 to 0) 6 months postoperatively: n = 29 median = 0 IQR (0 to 0) 1 year postoperatively: n = 28 median = 0 IQR (0 to 0)	TLH group: 6 months postoperative score versus pre‐operative score: P = 0.06 1 year postoperative score versus pre‐operative score: P < 0.05 NDVH group: 6 months postoperative score versus preoperative score: P = 0.69 1 year postoperative score versus pre‐operative score: P = 0.46
Ekanayake 2020	Questionnaire ICIQ‐VS. Vaginal symptoms pre‐operatively, 6 months and 1 year postoperatively. A high score means experiencing more vaginal symptoms	Pre‐operatively: n = 49 median = 4 IQR (2 to 10.5) 6 months postoperatively: n = 48 median = 3 IQR (0 to 6) 1 year postoperatively: n = 47 median = 4 IQR (0 to 10)	Pre‐operatively: n = 49 median = 6 IQR (4 to 8.5) 6 months postoperatively: n = 48 median = 4 IQR (0 to 8) 1 year postoperatively: n = 45 median = 5 IQR (0 to 8)	For both the NDVH and TLH group vaginal function domain scores at 6 months and 1 year postoperatively were statistically significant compared to the respective pre‐operative scores (P < 0.001)
Ekanayake 2020	Questionnaire ICIQ‐LUTS. Urinary symptoms pre‐operatively, 6 months and 1 year post‐operatively. A high score means experiencing more urinary symptoms	Urinary flow symptoms: Pre‐op: n = 49 median = 1 IQR (1 to 4) 6 months postop: n = 48 median = 1 IQR (0 to 3) 1 year postop: n = 47 median = 1 IQR (0 to 3) Urinary voiding symptoms: Pre‐op: n = 49 median = 0 IQR (0 to 0) 6 months postop: n = 48 median = 0 IQR (0 to 0) 1 year postop: n = 47 median = 0 IQR (0 to 0) Urinary incontinence symptoms: Pre‐op: n = 49 median = 0 IQR (0 to 3) 6 months postop: n = 48 median = 0 IQR (0 to 1.75) 1 year postop: n = 47 median = 0 IQR (0 to 2)	Urinary flow symptoms: Pre‐op: n = 49 median = 3 IQR (2 to 5) 6 months postop: n = 48 median = 2 IQR (0 to 4.75) 1 year postop: n = 45 median = 2 IQR (0.5 to 4) Urinary voiding symptoms: Pre‐op: n = 49 median = 0 IQR (0 to 1) 6 months postop: n = 48 median = 0 IQR (0 to 0.75) 1 year postop: n = 45 median = 0 IQR (0 to 1) Urinary incontinence symptoms: Pre‐op: n = 49 median = 0 IQR (0 to 3) 6 months postop: n = 48 median = 1 IQR (0.75 to 3) 1 year postop: n = 45 median = 0 IQR (0 to 3)	Urinary flow symptoms: TLH 6 months postoperative score versus pre‐operative score: P < 0.01 TLH 1 year postoperative score versus pre‐operative score: P < 0.05 NDVH 6 months postoperative score versus pre‐operative score: P < 0.001 NDVH 1 year postoperative score versus pre‐operative score: P < 0.001 Urinary voiding symptoms: TLH 6 months postoperative score versus pre‐operative score: P = 0.47 TLH 1 year postoperative score versus pre‐operative score: P < 0.05 NDVH 6 months postoperative score versus pre‐operative score: P < 0.05 NDVH 1 year postoperative score versus pre‐operative score: P < 0.05 Urinary incontinence symptoms: TLH 6 months postoperative score versus pre‐operative score: P = 0.21 TLH 1 year postoperative score versus pre‐operative score: P < 0.05 NDVH 6 months postoperative score versus pre‐operative score: P = 0.07 NDVH 1 year postoperative score versus pre‐operative score: P < 0.01

Pelvic‐abdominal pain, bowel dysfunction and pelvic floor condition were not reported for this comparison.

Secondary outcomes

3.5 Operation time

LAVH probably required a longer operation time than vaginal hysterectomy (MD 41.32 minutes, 95% CI 32.70 to 49.94; 12 RCTs, 905 women; I² = 96%). We are uncertain whether there is a difference in operative time between the three studies comparing TLH to VH (Allam 2015; Candiani 2009; Sesti 2014b), although the point estimate favoured VH (MD 41.89 minutes, 95% CI ‐5.52 to 89.31; 3 RCTs, 192 women; I² = 98%) (Analysis 3.9) (Figure 6). Heterogeneity was high for these comparisons, despite analysing the subcategory of LH separately, and was not explained by sensitivity analysis. Here, we felt surgeon experience likely to play a role in the heterogeneity, but there was insufficient information to fully evaluate this relationship.

3.9. Analysis.

Comparison 3: LH versus VH, Outcome 9: Operation time (mins)

6.

Six additional studies reported on operation time but could not be included in the meta‐analysis because of the descriptive format of the presented data (Ekanayake 2021; Hwang 2002; Nanavati 2016; Ribeiro 2003; Richardson 1995; Roy 2012). These studies all found longer operation times in laparoscopic hysterectomy, however only two reported a statistical test result. Hwang 2002 showed evidence of a difference and Roy 2012 did not (Analysis 3.23).

3.23. Analysis.

Comparison 3: LH versus VH, Outcome 23: Operation time (descriptive data)

Operation time (descriptive data)
Study	LH	VH	Comments
Ekanayake 2021	n = 49 Median = 93 mins IQR (80 to 111)	n = 49 Median = 50 mins IQR (35 to 65)	TLH vs NDVH Not tested separately
Hwang 2002	With 2nd proc: n = 13 Median = 119 Range (80 to 165) Without 2nd proc: n = 17 Median = 109 Range (85 to 175)	With 2nd proc: n = 3 Median = 93 Range (80 to 110) Without 2nd proc: n = 27 Median = 74 Range (40 to 120)	Kruskal Wallis test: P value = 0.12 P value < 0.001
Nanavati 2016	n = 50 mean 108 mins no IQR/SD given	n = 50 mean 77.5 mins no IQR/SD given	No IQR/SD given, no P value
Ribeiro 2003	n = 20 mean 119 mins (no measure of spread)	n = 20 mean 78 mins (no measure of spread)	—
Richardson 1995	n = 22 mean = 131.4 mins range (76 to 180)	n = 23 mean = 76.7 mins range (35 to 150)	Some of these cases include oophorectomies. Oophorectomy (mean): LH 129.7 mins, VH 95.3 mins; no oophorectomy (mean): LH 132.7 mins, VH 64.7 mins
Roy 2012	n = 10 median = 90 mins min‐max = 60 to 165 mins	n = 10 median = 75 min‐max = 40 to 105	Not statistically significant

3.6 (Sequelae of) bleeding

We are uncertain whether there is a difference in sequelae of bleeding complications between laparoscopic and vaginal hysterectomy: substantial bleeding (OR 1.37, 95% CI 0.29 to 6.39; 4 RCTs, 806 women; I² = 0%) (Analysis 3.10), the number of transfusions (OR 1.25, 95% CI 0.76 to 2.06; 14 RCTs, 1586 women; I² = 0%) (Analysis 3.11) and pelvic haematoma (OR 0.86, 95% CI 0.30 to 2.51; 6 RCTs, 463 women; I² = 0%) (Analysis 3.12).

3.10. Analysis.

Comparison 3: LH versus VH, Outcome 10: Bleeding

3.11. Analysis.

Comparison 3: LH versus VH, Outcome 11: Transfusion

3.12. Analysis.

Comparison 3: LH versus VH, Outcome 12: Pelvic haematoma

3.7 Unintended laparotomy

We are uncertain of a difference in unintended laparotomies between laparoscopic and vaginal hysterectomy (OR 1.40, 95% CI 0.72 to 2.71; 13 RCTs, 1414 women; I² = 0%) (Analysis 3.13).

3.13. Analysis.

Comparison 3: LH versus VH, Outcome 13: Unintended laparotomy

3.8 Short‐term outcomes and complications

Hospital stay was probably shorter after vaginal hysterectomy compared to laparoscopic hysterectomy when LH types were combined (MD 0.65 days, 95% CI 0.45 to 0.85; 11 RCTs, 912 women; I² = 82%) (Analysis 3.20). However, we are uncertain whether there is a difference in hospital stay when evaluating the two studies comparing TLH to VH (Candiani 2009; Sesti 2014b) (MD 0.58 days, 95% CI ‐0.90 to 2.06; 2 RCTs, 132 women; I² = 61%).

3.20. Analysis.

Comparison 3: LH versus VH, Outcome 20: Length of hospital stay (days)

Seven additional studies reported on differences in hospital stay, but could not be pooled in the meta‐analysis because of the descriptive format of the presented data (Allam 2015; Ekanayake 2021; Hwang 2002; Nanavati 2016; Richardson 1995; Roy 2011; Roy 2012). Three studies performed statistical testing. Allam 2015 found the median hospital stay following LH to be 0.75 days shorter than after VH. Roy 2011 and Roy 2012 did not show either a clear difference or equivalence.

There was no clear difference (or equivalence) in rates of vaginal cuff infection (OR 0.98, 95% CI 0.22 to 4.39; 4 RCTs, 276 women; I² = 0%, low‐certainty evidence) (Analysis 3.14). This suggests that if the rate of vaginal cuff infection following vaginal hysterectomy is assumed to be 2%, then following laparoscopic hysterectomy it would be 1% to 9%. We are also uncertain whether there is a difference in wound/abdominal wall infection between the two groups (OR 1.41, 95% CI 0.28 to 7.03; 4 RCTs, 363 women; I² = 0%, very low‐certainty evidence) (Analysis 3.15). This suggests that if the rate of wound/abdominal wall infection following vaginal hysterectomy is assumed to be 1%, then following laparoscopic hysterectomy it would be 0% to 14%. Similarly, there was unclear evidence of a difference in urinary tract infection (OR 2.12, 95% CI 0.60 to 7.50; 4 RCTs, 328 women; I² = 0%) (Analysis 3.16), chest infection (OR 0.19, 95% CI 0.01 to 4.06; 1 RCT, 60 women) (Analysis 3.17), febrile episodes or unspecified infection (OR 0.81, 95% CI 0.53 to 1.24; 12 RCTs, 1508 women; I² = 0%; low‐certainty evidence) (Analysis 3.18) and thromboembolic events (OR 1.38, 95% CI 0.28 to 6.88; 3 RCTs, 664 women; I² = 0%) (Analysis 3.19). Confidence intervals were wide and the certainty of the evidence was low due to low numbers of women and low rates of adverse events.

3.14. Analysis.

Comparison 3: LH versus VH, Outcome 14: Vaginal cuff infection

3.15. Analysis.

Comparison 3: LH versus VH, Outcome 15: Wound/abdominal wall infection

3.16. Analysis.

Comparison 3: LH versus VH, Outcome 16: Urinary tract infection

3.17. Analysis.

Comparison 3: LH versus VH, Outcome 17: Chest infection

3.18. Analysis.

Comparison 3: LH versus VH, Outcome 18: Febrile episodes or unspecified infection

3.19. Analysis.

Comparison 3: LH versus VH, Outcome 19: Thromboembolism

3.9 Postoperative ileus

No study in this comparison reported on this outcome.

3.10 Wound dehiscence

No study in this comparison reported on this outcome.

3.11 Costs

Four studies reported on operation costs. Garry 2004 (as published in Sculpher 2004) found that laparoscopic hysterectomy costs an average of GBP 401 (British pounds) more than vaginal hysterectomy (95% CI GBP 271 to 542). Additionally, in Summitt 1992 the mean total hospital cost was higher for LH than for VH. Ekanayake 2021 and Mohammed 2017 provide descriptive data, summarised in Analysis 3.25.

3.25. Analysis.

Comparison 3: LH versus VH, Outcome 25: Cost (descriptive data)

Cost (descriptive data)
Study	Description	LH	VH
Ekanayake 2021	Direct costs, which includes preoperative costs, operative costs, cost of hospital stay and costs up to 6 months after surgery Units of currency = US dollars (USD)	TLH n = 49 Median = 752 USD 95% CI (719 to 795)	NDVH n = 49 Median = 800 USD 95% CI (622 to 1116)
Mohammed 2017	The hospital costs were calculated and included: the admission cost, which included the ward fee, pre‐ and postoperative management costs and extra charges for any postoperative complications, the anaesthesia costs which included the drugs and the disposable instruments used by the anaesthesiologist, and the operation cost which included the operative material fee.	LAVH n = 25 Described as mean (SD) 1560.5 USD (220.5 USD)	n = 25 Described as mean (SD) 1060.86 USD (180.09 USD) P > 0.001
Summitt 1992	Mean total hospital charge when surgery was performed on an outpatient basis. Charges consisted of: operating room fee, operating room time, anaesthesia time, charges for disposable staples, scissors, graspers and a charge for recovery in the ambulatory surgery unit, including laboratory fees	n = 29 Mean = 7905 USD, SD = 501 USD, range (7197 to 8289) P value = 0.035	n = 27 Mean = 4891 USD, SD = 355 USD, range (4311 to 5247) P value = 0.035

4 Robotic‐assisted hysterectomy (RH) versus laparoscopic hysterectomy (LH)

Primary outcomes

4.1 Return to normal activities

Based on one small RCT evaluating return to normal activities between robotic‐assisted and laparoscopic hysterectomy (Sarlos 2012), we are uncertain whether there is a difference (MD 2.4 days, 95% CI ‐8.5 to 3.7 days; 1 RCT, 100 women; I² = n/a; very low‐certainty evidence) (Figure 2; Analysis 4.1). This suggests that if the return to normal activities after laparoscopic hysterectomy is assumed to be 31 days, then after robotic hysterectomy it would be between 22 and 35 days.

4.1. Analysis.

Comparison 4: RH versus LH, Outcome 1: Return to normal activities (days)

Data on return to normal baseline activities from the Paraiso 2013 study could not be pooled in the meta‐analysis, and did not demonstrate either a clear difference or equivalence between robotic‐assisted and laparoscopic hysterectomy (Analysis 4.10).

4.10. Analysis.

Comparison 4: RH versus LH, Outcome 10: Return to normal activities (descriptive data)

Return to normal activities (descriptive data)
Study	Description	RH	LH	Comment
Paraiso 2013	Percentage to return to normal baseline activities At 1, 2, 3, 4, 5 and 6 weeks postoperatively	1 week (n = 17): 22% 2 weeks (n = 17): 46% 3 weeks (n = 17): 54% 4 weeks (n = 17): 60% 5 weeks (n = 17): 66% 6 weeks (n = 16): 72%	1 week (n = 19): 29% 2 weeks (n = 19): 46% 3 weeks (n = 18): 58% 4 weeks (n = 18): 64% 5 weeks (n = 17): 73% 6 weeks (n = 17): 82%	P value (overall) = 0.25

4.2 Satisfaction and quality of life

These outcomes were not reported in studies comparing robotic‐assisted and laparoscopic hysterectomy.

4.3 Intraoperative visceral injury

Based on one RCT (Sarlos 2012), we are uncertain whether there is a difference in ureter injury (OR 0.33, 95% CI 0.01 to 8.21; 1 RCT, 100 women; very low‐certainty evidence) (Analysis 4.2). This suggests that if the rate of ureter injury during laparoscopic hysterectomy is assumed to be 2%, then during robotic hysterectomy it would be 0% to 14%. We are also uncertain whether there is a difference in vascular injury (OR 1.00, 95% CI 0.06 to 16.44; 1 RCT, 100 women; I² = n/a) (Analysis 4.2).

4.2. Analysis.

Comparison 4: RH versus LH, Outcome 2: Intraoperative visceral injury (dichotomous)

No study in this comparison reported on bladder injury or bowel injury.

4.4 Major long‐term complications

Fistula formation, pelvic‐abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition (prolapse) and sexual dysfunction were not reported in studies comparing robotic‐assisted and laparoscopic hysterectomy.

Secondary outcomes

4.5 Operation time

Based on two small RCTs (Paraiso 2013; Sarlos 2012), robotic‐assisted hysterectomy probably takes longer than laparoscopic hysterectomy (MD 44.09 minutes, 95% CI 5.31 to 82.88; 2 RCTs, 152 women; I² = 58%) (Analysis 4.3). Data from Deimling 2016 could not be included in the meta‐analysis (Analysis 4.9).

4.3. Analysis.

Comparison 4: RH versus LH, Outcome 3: Operation time

4.9. Analysis.

Comparison 4: RH versus LH, Outcome 9: Operation time (descriptive data)

Operation time (descriptive data)
Study	RH	LH	comment
Deimling 2016	Mean operation time 73.9 minutes Median 67.0 minutes (IQR 59.0 to 83.0 minutes)	Mean operation time 74.9 minutes Median 65.5 minutes (IQR 57.0 to 90.5 minutes)	The nonparametric, one‐sided, bootstrapped bias‐corrected and accelerated 95% CI of the difference in mean operative time was 6.6 minutes (P < 0.001) The upper bound of this 95% CI was smaller than the specified non‐inferiority margin of 15 minutes, indicating non‐inferiority

4.6 (Sequelae of) bleeding

We are uncertain whether there is a difference between robotic‐assisted and laparoscopic hysterectomy regarding substantial bleeding (OR 0.08, 95% CI 0.00 to 1.56; 1 RCT, 144 women; I² = n/a) (Analysis 4.4) or the need for transfusion (OR 2.08, 95% CI 0.18 to 24.51; 1 RCT, 52 women; I² = n/a) (Analysis 4.6). Pelvic haematoma was not reported for this comparison.

4.4. Analysis.

Comparison 4: RH versus LH, Outcome 4: Bleeding

4.6. Analysis.

Comparison 4: RH versus LH, Outcome 6: Transfusion

4.7 Unintended laparotomy

Rates of unintended laparotomy were not reported for this comparison.

4.8 Short‐term outcomes and complications

We are uncertain of a difference between robotic‐assisted and laparoscopic hysterectomy for wound/abdominal wall infection (OR 0.60, 95% CI 0.08 to 4.57; 2 RCTs, 244 women; I² = 0%; low‐certainty evidence) (Analysis 4.7). This suggests that if the rate of wound/abdominal wall infection following laparoscopic hysterectomy is assumed to be 2%, then during robotic hysterectomy it would be 0% to 7%.

4.7. Analysis.

Comparison 4: RH versus LH, Outcome 7: Wound/abdominal wall infection

We are uncertain of a difference between robotic‐assisted and laparoscopic hysterectomy in unspecified infection (OR 1.00, 95% CI 0.06 to 16.30; 1 RCT, 144 women; I² = n/a) (Analysis 4.8).

4.8. Analysis.

Comparison 4: RH versus LH, Outcome 8: Febrile episodes or unspecified infections

Length of hospital stay, other infections (vaginal cuff, urinary tract infection, chest infection, febrile episodes) and thromboembolism were not reported for this comparison.

4.9 Postoperative Ileus

No study in this comparison reported on this outcome.

4.10 Wound dehiscence

We are uncertain of a difference in wound dehiscence between robotic‐assisted and laparoscopic hysterectomy (OR 1.00, 95% CI 0.17 to 5.86; 2 RCTs, 244 women; I² = 0%; low‐certainty evidence) (Analysis 4.5)

4.5. Analysis.

Comparison 4: RH versus LH, Outcome 5: Wound dehiscence

4.11 Costs

No study in this comparison reported on this outcome.

5. Single‐port laparoscopic hysterectomy subcategory (SP‐LH) versus laparoscopic hysterectomy (LH) subcategories

Primary outcomes

5.1 Return to normal activities

No study in this comparison reported on this outcome.

5.2 Satisfaction and quality of life

No study in this comparison reported on this outcome.

5.3 Intraoperative visceral injury

We are uncertain of a difference between single‐port total laparoscopic hysterectomy and laparoscopic hysterectomy for bladder injury (OR 3.51, 95% CI 0.14 to 89.42; 1 RCT, 64 women; very low‐certainty evidence) (Analysis 5.1). This suggests that if the rate of bladder injury during laparoscopic hysterectomy is assumed to be 0%, then during single‐port laparoscopic hysterectomy it would also be 0%. Similarly, we are uncertain of a difference for ureteral injury (OR 0.33, 95% CI 0.01 to 8.26; 1 RCT, 251 women; very low‐certainty evidence) (Analysis 5.2). This suggests that if the rate of ureter injury during laparoscopic hysterectomy is assumed to be 1%, then during single‐port laparoscopic hysterectomy it would be 0% to 6%.

5.1. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 1: Bladder injury

5.2. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 2: Ureter injury

Bowel and vascular injury were not reported in studies comparing SP‐LH and LH.

5.4 Major long‐term complications

No studies in this comparison reported on fistula, pelvic‐abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition or sexual dysfunction.

Secondary outcomes

5.5 Operation time

Single‐port laparoscopic hysterectomy may take slightly longer than laparoscopic hysterectomy (MD 14.95 minutes, 95% CI 7.53 to 22.38; 4 RCTs, 262 women; I² = 90%) (Analysis 5.10).

5.10. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 10: Operation time (mins)

Data from Song 2013 on operation time could not be pooled. It did not show clear difference or equivalence (LAVH median = 92 minutes; SP‐LAVH median = 95 minutes, P value = 0.47). Data from Kim 2015 were descriptive in nature and median SP‐LH time was 80 minutes compared to 69.5 minutes in the LH group (Analysis 5.12).

5.12. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 12: Operation time (descriptive data)

Operation time (descriptive data)
Study	SP‐LH	Conventional LH	Comments
Kim 2015	n = 125 Sp‐LHa Median operative time, min Range 80 (30 to 250)	n = 126 Median operative time 69.5 Range (25 to 240)	P = 0.22
Song 2013	n = 20 SP‐LAVH Mean = 92 min Range 57 to 220 min	n = 19 LAVH Mean = 95 min Range 70 to 154 min	P = 0.47

5.6 (Sequelae of) bleeding

We are uncertain whether there is a difference between the groups for the following outcomes: transfusion (OR 0.78, 95% CI 0.34 to 1.77; 6 RCTs, 552 women; I² = 0%) (Analysis 5.4) and pelvic haematoma (OR 3.06, 95% CI 0.12 to 76.95; 1 RCT, 100 women; I² = n/a) (Analysis 5.5).

5.4. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 4: Transfusion

5.5. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 5: Pelvic haematoma

5.7 Unintended laparotomy

We are uncertain whether there is a difference in rates of conversion to laparotomy (OR 5.21, 95% CI 0.60 to 45.23; 1 RCT, 251 women; I² = n/a; low‐certainty evidence) (Analysis 5.3).

5.3. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 3: Conversion or aditional port placement

5.8 Short‐term outcomes and complications

Chen 2011 found no clear difference or equivalence in hospital stay between LAVH and SP‐LAVH (MD ‐0.20 days, 95% CI ‐0.49 to 0.09; 1 RCT, 100 women; I² = n/a) (Analysis 5.11).

5.11. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 11: Length of hospital stay (days)

Further data on hospital stay from three RCTs could not be pooled (Song 2013: median TLH 3 days versus median SP‐TLH 3 days, P value = 0.95; Jung 2011: TLH median 3 days versus SP‐TLH 3.4 days, P value = 0.075; Kim 2015: SP‐non‐categorisable LH median 3 days versus multi‐port non‐categorisable LH median 3 days, P value = 0.45) (Analysis 5.13).

5.13. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 13: Length of hospital stay (descriptive data)

Length of hospital stay (descriptive data)
Study	SP‐LH	LH	Comments
Jung 2011	n = 30 SP‐TLH Median postoperative hospital stay = 3.4 days Range 3.0 to 4.3 days	n = 34 TLH Median postoperative hospital stay = 3.0 days Range 3.0 to 3.0 days	P value = 0.075
Kim 2015	n = 125 SP‐NC LH Median postoperative hospital stay 3 days Range (2 to 7)	n = 125 NC LH Median postoperative hospital stay 3 days Range (2 to 13)	P value = 0.45
Song 2013	n = 20 SP‐LAVH Mean = 3 days Range 2 to 4 days	n = 19 LAVH Mean = 3 days Range 2 to 4 days	P value = 0.95

We are uncertain whether there is a difference for wound/abdominal wall infection between LH and SP‐LH (OR 1.03, 95% CI 0.20 to 5.15; 3 RCTs, 411 women; I² = 0%; low‐certainty evidence) (Analysis 5.6). This suggests that if the rate of wound/abdominal wall infection following laparoscopic hysterectomy is assumed to be 1%, then following single‐port laparoscopic hysterectomy it would be 0% to 5%.

5.6. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 6: Wound/abdominal wall infection

We are uncertain whether there is a difference in febrile episodes or unspecified infections between the SP‐LH group and LH group (OR 2.56, 95% CI 0.70 to 9.44; 2 RCTs, 315 women; I² = 53%; very low‐certainty evidence) (Analysis 5.7). This suggests that if the rate of febrile episodes or unspecified infection following laparoscopic hysterectomy is assumed to be 2%, then following single‐port laparoscopic hysterectomy it would be 1% to 15%.

5.7. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 7: Febrile episodes or unspecified infection

Other infections (vaginal cuff, urinary tract or chest infection) and thromboembolism were not reported in the studies included in this comparison.

5.9 Postoperative ileus

We are uncertain whether there is a difference in postoperative ileus occurrence between SP‐LH and LH (OR 2.36, 95% CI 0.20 to 27.39; 1 RCT, 64 women; I² = n/a) (Analysis 5.9).

5.9. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 9: Postoperative ileus

5.10 Wound dehiscence

Based on one study (Chung 2015), we are uncertain of a difference in vaginal cuff dehiscence between the SP‐LH and LH groups (OR 3.11, 95% CI 0.12 to 79.43; 1 RCT, 58 women; I² = n/a) (Analysis 5.8).

5.8. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 8: Vaginal cuff dehiscence

5.11 Cost

One study reported similar costs of laparoscopic instruments for SP‐LH and LH (Chung 2015).

6. Total laparoscopic hysterectomy (TLH) versus laparoscopic‐assisted vaginal hysterectomy (LAVH)

Primary outcomes

6.1 Return to normal activities

No study in this comparison reported on this outcome.

6.2 Satisfaction and quality of life

No study in this comparison reported on this outcome.

6.3 Intraoperative visceral injury

We are uncertain whether there is a difference in bladder injury (OR 0.72, 95% CI 0.06 to 8.27; 2 RCTs, 161 women; I² = n/a; low‐certainty evidence) (Analysis 6.1). This suggests that if the rate of bladder injury during laparoscopic‐assisted vaginal hysterectomy is assumed to be 2%, then during total laparoscopic hysterectomy it would be 0% to 16%.

6.1. Analysis.

Comparison 6: TLH versus LAVH, Outcome 1: Intraoperative visceral injury (dichotomous)

We are also uncertain whether there is a difference in ureter injury rates for this comparison (OR 3.03, 95% CI 0.27 to 34.52; 2 RCTs, 161 women; I² = n/a; low‐certainty evidence) (Analysis 6.1), or urinary tract (bladder or ureter) injury (OR 1.50, 95% CI 0.29 to 7.83; 3 RCTs, 233 women; I² = n/a) (Analysis 6.1). This suggests that if the rate of ureter injury during laparoscopic‐assisted vaginal hysterectomy is assumed to be 1%, then during total laparoscopic hysterectomy it would be 0% to 28%.

In the two studies in which it was reported, no bowel injuries occurred in either group.

We are also uncertain whether there is a difference in rates of vascular injury for the comparison TLH versus LAVH (OR 1.48, 95% CI 0.09 to 24.27; 1 RCT, 101 women) (Analysis 6.1).

6.4 Major long‐term complications

One study reported on sexual dysfunction following TLH versus LAVH. We are uncertain whether there is a difference in dyspareunia (OR 2.64, 95% CI 0.59 to 11.72; 1 RCT, 101 women) (Analysis 6.2) or failure to orgasm (OR 0.84, 95% CI 0.38 to 1.86; 1 RCT, 101 women) (Analysis 6.2).

6.2. Analysis.

Comparison 6: TLH versus LAVH, Outcome 2: Long‐term complications (dichotomous)

Studies for this comparison did not report on the other major long‐term complications (fistula formation, pelvic‐abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition).

Secondary outcomes

6.5 Operation time

LAVH may have a shorter operation time than TLH (MD ‐23.36 minutes, 95% CI ‐34.22 to ‐12.50; 3 RCTs, 173 women; I² = 0%) (Analysis 6.3).

6.3. Analysis.

Comparison 6: TLH versus LAVH, Outcome 3: Operation time (mins)

6.6 (Sequelae of) bleeding

We are uncertain whether there is a difference between TLH and LAVH in the number of patients requiring blood transfusion (OR 0.72, 95% CI 0.18 to 2.83; 3 RCTs, 233 women; I² = 0%) (Analysis 6.5).

6.5. Analysis.

Comparison 6: TLH versus LAVH, Outcome 5: Short‐term outcomes (dichotomous)

Studies in this comparison did not report on substantial bleeding or pelvic haematoma.

6.7 Unintended laparotomy

We are uncertain whether there is a difference in the number of unintended laparotomies between LAVH and TLH (OR 1.28, 95% CI 0.21 to 7.85; 3 RCTs, 236 women; I² = 0%; low‐certainty evidence) (Analysis 6.4).

6.4. Analysis.

Comparison 6: TLH versus LAVH, Outcome 4: Unintended laparotomy

6.8 Short‐term outcomes and complications

We are uncertain whether there is a difference in hospital stay for TLH versus LAVH (MD 0.01 days, 95% CI ‐0.35 to 0.37; 2 RCTs, 173 women; I² = 0%) (Analysis 6.6). We are uncertain whether there is a difference between TLH and LAVH for vaginal cuff infection (OR 0.28, 95% CI 0.03 to 2.45; 1 RCT, 101 women; very low‐certainty evidence) (Analysis 6.5). This suggests that if the rate of vaginal cuff infection following laparoscopic‐assisted vaginal hysterectomy is assumed to be 8%, then following total laparoscopic hysterectomy it would be 0% to 18%. We are similarly uncertain whether there is a difference in abdominal wall/wound infection (OR 0.19, 95% CI 0.01 to 4.06; 1 RCT, 60 women; very low‐certainty evidence) (Analysis 6.5). This suggests that if the rate of abdominal wall/wound infection following laparoscopic‐assisted vaginal hysterectomy is assumed to be 7%, then following total laparoscopic hysterectomy it would be 0% to 23%. We are uncertain whether there is a difference between TLH and LAVH in rates of urinary tract infection (OR 1.00, 95% CI 0.13 to 7.60; 1 RCT, 60 women) (Analysis 6.5). We are uncertain of a difference in febrile episodes (OR 0.61, 95% CI 0.15 to 2.45; 3 RCTs, 233 women; I² = 35%; low‐certainty evidence) (Analysis 6.5). This suggests that if the rate of febrile episodes or unspecified infection following laparoscopic‐assisted vaginal hysterectomy is assumed to be 5%, then following total laparoscopic hysterectomy it would be 2% to 29%.

6.6. Analysis.

Comparison 6: TLH versus LAVH, Outcome 6: Length of hospital stay (days)

Studies in this comparison did not report on chest infection or thromboembolism.

6.9 Postoperative ileus

No study in this comparison reported on this outcome.

6.10 Wound dehiscence

No study in this comparison reported on this outcome.

6.11 Costs

No study in this comparison reported on this outcome.

7. V‐NOTES versus laparoscopic hysterectomy (LH)

Primary outcomes

7.1 Return to normal activities

No study in this comparison reported on this outcome.

7.2 Satisfaction and quality of life

No study in this comparison reported on this outcome.

7.3 Intraoperative visceral injury

We are uncertain whether there is a difference in the incidence of bladder injury for V‐NOTES versus LH (OR 3.09, 95% CI 0.12 to 78.41; 2 RCTs, 96 women; I² = n/a; low‐certainty evidence) (Analysis 7.3). This suggests that if the rate of bladder injury during V‐NOTES hysterectomy is assumed to be 0%, then during laparoscopic hysterectomy it would also be 0%.

7.3. Analysis.

Comparison 7: V‐NOTES versus LH, Outcome 3: Bladder injury

No study in this comparison reported on ureteral, bowel or vascular injury.

7.4 Major long‐term complications

Studies comparing V‐NOTES hysterectomy and laparoscopic hysterectomy did not report on major long‐term complications (fistula formation, pelvic‐abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition, sexual dysfunction).

Secondary outcomes

7.5 Operation time

Baekelandt 2019 reported on operative time and found that V‐NOTES was 34 minutes faster on average than TLH (95% CI ‐45.54 to ‐22.46; 1 RCT, 70 women) (Baekelandt 2019). A second study found that the median operative time for V‐NOTES was 55 minutes compared to 75 minutes for single‐port LH (Analysis 7.8) (Park 2021).

7.8. Analysis.

Comparison 7: V‐NOTES versus LH, Outcome 8: Operation time (descriptive data)

Operation time (descriptive data)
Study	vNOTES	LH	Comments
Park 2021	n = 13 Median = 55 mins Range (25 to 105)	n = 13 Median = 75 mins Range (50 to 110)	LH group regards laparo‐endoscopic single site surgery (LESS)

7.6 (Sequelae of) bleeding

We are uncertain whether there is a difference in significant bleeding events between V‐NOTES and laparoscopic hysterectomy (OR 1.00, 95% CI 0.06 to 17.90; 1 RCT, 26 women) (Analysis 7.6).

7.6. Analysis.

Comparison 7: V‐NOTES versus LH, Outcome 6: Substantial bleeding

No study in this comparison reported on transfusion or pelvic haematoma.

7.7 Unintended laparotomy

No conversions to laparotomy occurred in either the V‐NOTES or laparoscopic hysterectomy arms in the two studies in which this outcome was reported (Baekelandt 2019; Park 2021; 96 women; Analysis 7.1).

7.1. Analysis.

Comparison 7: V‐NOTES versus LH, Outcome 1: Conversion or additional port placement

7.8 Short‐term outcomes and complications

In Baekelandt 2019, women undergoing V‐NOTES hysterectomy had a shorter hospital stay by half a day compared to those who underwent laparoscopic hysterectomy (MD ‐0.50, 95% CI ‐0.97 to ‐0.03; 1 RCT, 70 women) (Analysis 7.5).

7.5. Analysis.

Comparison 7: V‐NOTES versus LH, Outcome 5: Length of hospital stay (days)

We are uncertain whether there is a difference in abdominal wall/wound infection (OR 3.24, 95% CI 0.12 to 87.13; 1 RCT, 26 women; very low‐certainty evidence) (Analysis 7.7). This suggests that if the rate of abdominal wall/wound infection following V‐NOTES hysterectomy is assumed to be 0%, then following laparoscopic hysterectomy it would also be 0%.

7.7. Analysis.

Comparison 7: V‐NOTES versus LH, Outcome 7: Wound/abdominal wall infection

Similarly, we are uncertain whether there is a difference between V‐NOTES and laparoscopic hysterectomy in rates of febrile episodes or unspecified infection (OR 1.00, 95% CI 0.17 to 6.01; 2 RCTs, 96 women; I² = 0%; low‐certainty evidence) (Analysis 7.4). This suggests that if the rate of febrile episodes or unspecified infection following V‐NOTES hysterectomy is assumed to be 4%, then following laparoscopic hysterectomy it would be 1% to 20%.

7.4. Analysis.

Comparison 7: V‐NOTES versus LH, Outcome 4: Febrile episodes or unspecified infection

No studies for this comparison reported on other infections (vaginal cuff, urinary tract or chest infections) or thromboembolism.

7.9 Postoperative ileus

No study in this comparison reported on this outcome.

7.10 Wound dehiscence

No study in this comparison reported on this outcome.

7.11 Costs

No study in this comparison reported on this outcome.

Sensitivity analyses

Exclusion of trials susceptible to inadequate sequence generation during the randomisation process

We excluded from the analyses 13 trials with unclear or detrimental sequence generation (Ellstrom 1998; Kunz 1996; Long 2002; Olsson 1996; Perino 1999; Ribeiro 2003; Silva Filho 2006; Mustea 2019; Nanavati 2016; Panda 2015; Parveen 2013; Tormena 2017; Wakhloo 2015). This altered the results as follows: wound and abdominal wall infection in VH versus AH was no longer significantly different. Ureter injury and transfusion in LH versus AH were no longer significantly different. Wound and abdominal wall infection in LAVH versus AH and LH method unspecified versus AH were no longer significantly different.

Exclusion of trials susceptible to 'surgeon effect'

Exclusion of the four trials in which the surgeons for one intervention were unequivocally different to those performing the other intervention did not alter the statistical significance of any meta‐analysis results (Kluivers 2007; Langebrekke 1996; Olsson 1996; Raju 1994).

Discussion

Summary of main results

Consistent with prior versions of this review, vaginal hysterectomy offers advantages over the other routes of hysterectomy. Based on our meta‐analysis it is possibly associated with faster return to normal activities, fewer wound/abdominal wall infections and shorter hospital stay than abdominal hysterectomy. When compared to laparoscopic hysterectomy, we are uncertain whether there is a difference in time to return to normal activities, but vaginal hysterectomy is probably associated with shorter operative time and shorter hospital stay. Intraoperative visceral injury was rare with both procedures and despite the number of studies in this review our meta‐analysis was likely underpowered to detect differences in these outcomes. Laparoscopic hysterectomy probably offers a number of advantages over abdominal hysterectomy. Among these are faster return to normal activities, shorter hospital stay, decreased risk of wound/abdominal wall infection, febrile episodes or unspecified infection, and transfusion. These advantages must be balanced against the likely increased risk of ureteric injury and longer operative time associated with laparoscopic compared to abdominal hysterectomy.

Notably, in this update to the review we found a probable increased risk of ureteral injury after laparoscopic hysterectomy when compared to abdominal hysterectomy (the prior review had to pool ureteral and bladder injury to power a difference from abdominal hysterectomy). This review also had the power to detect a probable lower risk of blood transfusion in the laparoscopic compared to the abdominal hysterectomy group.

We remain uncertain of any advantage or disadvantage to robotic‐assisted hysterectomy compared to laparoscopic hysterectomy. This update added only one new RCT comparing robotic hysterectomy to laparoscopic hysterectomy, and operation time remained longer in the robotic hysterectomy group. Similarly, we are uncertain of any advantage or disadvantage to single‐port hysterectomy over conventional laparoscopic hysterectomy, other than better cosmetic outcomes. In this update, multiple single‐port to conventional laparoscopic hysterectomy comparison studies were added, showing a longer operative time associated with the single‐port laparoscopic hysterectomy group. Comparisons of vaginal natural orifice surgery (V‐NOTES) to total laparoscopic hysterectomy were new and, in one small study, V‐NOTES performed by an experienced surgeon was associated with shorter operative time and shorter hospital stay than total laparoscopic hysterectomy.

In conclusion, it seems that whenever vaginal hysterectomy can safely achieve all outcomes of relevance to the patient, it should be the preferred route to other approaches. Comparisons between procedures on surgical safety are limited due to the low number of adverse events in this review. Cost and long‐term outcome comparisons are hindered by lack of reporting and consistency of reporting methods.

Overall completeness and applicability of evidence

When evaluating the overall completeness and applicability of the evidence included in this review, the findings must be considered in the context of four main limitations: 1) the small sample size of the studies does not lend itself to the detection of differences in rare complication rates; 2) surgical skills and learning curve likely contribute to heterogeneity in our results and are poorly reported in the studies; 3) the varied inclusion criteria of the studies may limit generalisability; and 4) there is need for greater consistency of outcome reporting with prioritisation of long‐term, patient‐centred outcomes.

Most of the RCTs included in this review had relatively small sample sizes and were not designed with the power to assess complication rates. Sometimes large cohort studies are better equipped to detect differences in rare complications. There are three recent large cohort studies assessing complications after several types of hysterectomy with which to compare our findings (Kreuninger 2018, n = 3981; Lonky 2017, n = 3490; Luchristt 2021). Kreuninger 2018 compared AH, LH, RH and VH with each other and Lonky 2017 compared LAVH, LSH, SAH, TAH, TLH and VH with each other. Both studies found that mostly (pelvic) abscess formation caused significant readmission after laparoscopic and abdominal hysterectomies. Additionally, Lonky 2017 found that vaginal cuff complications most frequently occurred after laparoscopic hysterectomy. Within the vaginal hysterectomy groups there were no statistically significant results, but the main complication was urinary tract infection. Luchristt 2021, with 161,626 women undergoing VH, TLH or LAVH, found that VH resulted in significantly more urinary tract infections, and more blood transfusions and deep surgical site infections compared to TLH and LAVH. However, they reported that TLH and LAVH were significantly associated with greater rates of wound dehiscence, superficial surgical site infections and venous thromboembolisms. Even though there were associations with different complications within each group, no minimally invasive route proved superior to the other (Kreuninger 2018; Lonky 2017; Luchristt 2021).

Unfortunately, the description of surgical skills in the included studies was not specific enough to assess learning curve effects for the different routes of hysterectomy in a sensitivity analysis. Mäkinen 2001 conducted a prospective study on the learning curve in 10,110 hysterectomies for benign indications, of which 5875 were AH, 1801 were VH and 2434 were LH. The surgeons' experience correlated inversely with the occurrence of urinary tract injuries in LH and the occurrence of bowel injuries in vaginal hysterectomy. In a follow‐up study, the overall complication rates fell significantly in LH and markedly in VH over the course of 10 years (Mäkinen 2013). Differences in surgical skills likely explain some statistical heterogeneity of the trials included in this review, and we anticipate that the effect of a particular surgeon’s skill with a given procedure might vary greatly for newer techniques. Remarkably, none of the studies included in the current update of this review reported on learning curves.

When assessing the overall applicability of the evidence, it must also be noted that most studies in this review had specific and varied inclusion criteria. For example, studies including an AH arm as the control often excluded women who were not eligible for the less invasive approach to hysterectomy of their intervention arm. This results in an AH patient population that is likely not representative of the entire abdominal hysterectomy population in our clinical practice, given that AH is often reserved for those patients in whom a minimally invasive approach is not feasible. In general, the variations in inclusion and exclusion criteria across studies might make it difficult to extrapolate the findings to everyday practice, where one is confronted with patients that have more than one problem, a higher body mass index or a surgical history that surpasses that of most included patients in the studies in this review.

Finally, we found widespread variation in reporting of outcomes, and many studies did not report on the primary outcomes of our review. This makes it difficult to perform a meta‐analysis or draw clinically relevant conclusions. The CoRe Outcomes in Women’s and Newborn health (CROWN) initiative is working to address this issue by creating standardised outcome sets (Khan 2014). We support this effort and feel that it would be worthwhile to develop a core set of outcomes for the evaluation of hysterectomy.

Quality of the evidence

We included 63 randomised controlled trials involving 6811 participants in this review. The certainty of the evidence for the comparisons is mainly graded as low or moderate, resulting in uncertainty regarding the effects on primary and secondary outcomes between the different approaches to hysterectomy (Table 1; Table 2; Table 3; Table 4; Table 5; Table 6; Table 7).

Reasons for downgrading the evidence most often stemmed from the risk of bias in the individual studies included in the comparison, inconsistency and imprecision of results.

Risk of bias in the studies was most often due to inadequate reporting of randomisation and allocation concealment procedures, lack of blinding, and lack of reporting on predefined outcomes and surgeon experience. While it is obviously difficult to blind to route of procedure, a few studies did use sham dressings to blind participants. This is particularly beneficial for obtaining unbiased patient‐reported outcomes, such as satisfaction or quality of life. However, none of the trials using sham dressings reported on the effectiveness of their blinding method. Trials studying short‐term outcomes in short follow‐up periods had minimal missing data. However, importantly, some trials evaluating long‐term outcomes, such as quality of life (e.g. Garry 2004), had significant numbers lost to follow‐up. Therefore, the outcomes of these studies must be interpreted with caution.

We downgraded the certainty of evidence due to inconsistency for several comparisons. In the analysis of vaginal hysterectomy compared to abdominal hysterectomy, studies consistently demonstrated faster return to normal activities for vaginal hysterectomy, making this one of our most well‐supported findings. In contrast, we found great heterogeneity in outcomes such as operative time for the various routes (for example, Analysis 3.9). Sometimes heterogeneity could be explained by sensitivity analysis (the specific subtype of laparoscopic hysterectomy, or exclusion of poorer‐quality trials). At other times, it could not be fully explained and, as discussed in Overall completeness and applicability of evidence, this may be due to surgeon skill or learning curve effects.

A third reason for downgrading the certainty of evidence was imprecision of results. This was mostly due to the low number of adverse events (intraoperative and major long‐term complications) per study, particularly among the minimally invasive routes. This must be considered when interpreting the safety of each type of hysterectomy.

In conclusion, further research is at least likely to have an important impact on our confidence in the estimates of effect for many comparisons and is likely to change the estimates for comparisons of complication rates.

Potential biases in the review process

We used a rigorous process to identify all relevant studies, but we excluded grey literature. Attempts to contact authors of studies lacking sufficient data to include them in this review were overall not successful.

Eight multi‐arm trials have been included in the review, where data have been used twice in different comparisons (Allam 2015; Ekanayake 2021; Hwang 2002; Nanavati 2016; Ottosen 2000; Panda 2015; Ribeiro 2003; Sesti 2008a). There is not an agreed approach to this problem. Since no large effects of correlation and non‐independence of data are expected on the resulting conclusions, we took no special measures in the review to address this issue. Similar correlation between the two trials and inter‐dependence of data might be present in the study Garry 2004, where the surgeon, and not the randomisation process, decided in which trial a patient was included.

We followed procedures to reduce other potential bias in the review process.

Agreements and disagreements with other studies or reviews

Several other reviews and studies have evaluated different approaches to hysterectomy. Kovac 2014 reported that, in general, vaginal hysterectomy is associated with better outcomes and has fewer complications than laparoscopic or abdominal hysterectomy. Similarly, in the systematic review Sandberg 2017, when VH was compared to laparoscopic hysterectomy it was associated with shorter operative times, lower risk of conversion and lower risk of vaginal cuff dehiscence. The Committee on Gynecologic Practice of the American College of Obstetrics & Gynecology also concludes that VH is the preferred route whenever feasible (ACOG 2009). Furthermore, it is mentioned that LH is an alternative to AH for those women for whom a VH is not indicated or feasible.

Pynnä 2014 performed a systematic review of studies that have investigated the cost‐effectiveness of hysterectomy for benign gynaecological disease. They concluded that the cost‐effectiveness of hysterectomy has been surprisingly poorly studied and that conclusions are difficult to draw due to the different study designs, indications, follow‐up times and quality of life instruments used. We also found this to be true.

Smorgick 2014 studied the benefits and challenges of robotic‐assisted hysterectomy. Conforming with our review, they found that recent studies comparing robotic and laparoscopic hysterectomy for benign indications have not demonstrated a clear advantage for either approach in terms of complications, blood loss and hospital stay. The higher cost of robotic hysterectomy remains a significant disadvantage of this approach, although definitive evidence is lacking.

Authors' conclusions

Implications for practice.

Among women undergoing hysterectomy for benign disease, vaginal hysterectomy appears superior to abdominal hysterectomy, as it is probably associated with a speedier return to normal activities. When technically feasible, vaginal hysterectomy should be performed in preference to abdominal hysterectomy because of a probable more rapid recovery and fewer abdominal wall infections postoperatively. Where vaginal hysterectomy is not possible, laparoscopic hysterectomy likely has multiple advantages over abdominal hysterectomy (including probable lower operative blood loss, more rapid recovery, fewer febrile episodes, fewer wound or abdominal wall infections, and fewer blood transfusions). These benefits are offset by a probable longer operating time and increased risk of ureteral injury. No advantages of laparoscopic over vaginal hysterectomy could be found; laparoscopic hysterectomy has a probable longer operation time and higher cost. Single‐port laparoscopic and robotic‐assisted hysterectomy should be either abandoned or further evaluated since there is a lack of evidence of any patient benefit over conventional laparoscopic hysterectomy. The V‐NOTES procedure also requires further study but shows some promise amongst expert surgeons in terms of operative time and length of hospital stay compared to conventional laparoscopy.

The surgical approach to hysterectomy should be decided by the woman in discussion with her surgeon, considering the relative benefits and hazards. Surgical expertise is likely to influence this decision and was often inadequately reported in the studies in this review. Finally, adverse event rates were low for all routes of hysterectomy, resulting in low power to detect differences in these outcomes.

Implications for research.

The concept of evidence‐based gynaecological surgery has been challenged by the many pitfalls encountered when performing randomised controlled trials (RCTs) to assess surgical interventions (Johnson 2009). However, our extensive systematic review shows the concept of evidence‐based gynaecological surgery to be alive and well. When the quality of RCTs of surgical interventions is sufficiently good, this yields information unrivalled in its quality compared to studies of other designs that assess surgical interventions.

The enhanced evidence on short‐term outcomes and adverse events generated by this meta‐analysis would benefit from large study populations, with surgeons well beyond their learning curve. Prior versions of this review were criticised for containing data from studies done when laparoscopy was first introduced. This update includes RCTs up to and including the year 2021. Since laparoscopic hysterectomy (LH) was introduced over 20 years ago, one would assume that the more recent studies would involve more experienced laparoscopists, but we did not find that to be the case.

This review did not include direct comparisons of the varied surgical techniques used to perform each route of surgery, only the routes of surgery themselves. Therefore, it is not designed to answer questions regarding the superiority of specific surgical instruments or techniques (for example, whether use of a uterine manipulator decreases the risk of ureteral injury at the time of LH), though surgical technique varied across studies and is likely to affect outcomes (van den Haak 2015). Further research is needed in these areas.

There is an absence of data for long‐term outcomes in RCTs comparing surgical approaches to hysterectomy. RCTs should aim to report long‐term outcomes, including urinary, bowel and sexual function, along with occurrence of fistulae.

The choice of the preferred route of hysterectomy should always be decided together with the patient based on the best available evidence but also on what matters most to the individual. It is therefore important to understand the impact of the different procedures on patient‐reported outcomes measures (PROMs), such as the quality of life domains of physical or sexual functioning. Because they reflect patients' values and circumstances, PROMs can assist in shared decision‐making (Dawson 2010). Only a few studies in the meta‐analysis have used quality of life as an outcome measure. The findings indicate that the laparoscopic and vaginal procedures performed better or equally compared with abdominal hysterectomy in the first weeks after the procedure, and laparoscopic hysterectomy performed better after four years. However, quality of life data do not lend themselves easily to meta‐analysis (due to the use of diverse tools, time frames and statistical analysis). Future studies should include PROMs as an outcome measure, preferably using well‐validated instruments applied in a standardised manner.

Finally, reporting of the costs of the different routes is particularly important, including consideration of societal and environmental impact and costs. Measures to reduce the carbon footprint from laparoscopic procedures are increasingly reported (Thiel 2015). Life cycle assessment results for the different hysterectomy routes showed that currently the vaginal hysterectomy is the least polluting option (Thiel 2018). Future studies should consider the environmental impact among their outcomes.

What's new

Date	Event	Description
29 August 2023	New citation required and conclusions have changed	With the addition of results from 17 new publications (16 studies), some of the conclusions have changed (Allam 2015; Baekelandt 2019; Chung 2015; Deimling 2016; Eggemann 2018; Ekanayake 2020; Ekanayake 2021; Kim 2015; Mohammed 2017; Mustea 2019; Nanavati 2016; Panda 2015; Park 2021; Parveen 2013; Sesti 2014b; Tormena 2017; Wakhloo 2015). The prior review found urinary tract injury occurred more often in LH compared to AH. In this review we were able to determine that was due to risk of ureteral injury (versus bladder injury). We also found that LH was associated with lower risk of blood transfusion than AH. We found operative time for SP‐LH may be longer than for laparoscopic hysterectomy. Finally, V‐NOTES may be faster and associated with slightly shorter hospital stay than LH.
29 August 2023	New search has been performed	New authors: Charlotte Pickett, Dachel Seeratan, Tijmen Bonestroo. We have included one new type of intervention in the review; this emerged as a new approach to hysterectomy in randomised controlled trials, i.e. V‐NOTES hysterectomy. We have excluded subtypes of interventions, as we did not consider these as different from AH or LH, i.e. mini‐LH, mini‐laparotomy. We have reduced the number of subcategories for LH (i.e LH(a)). In this review we re‐define TLH (the complete procedure performed laparoscopically with closure of the vaginal cuff either vaginally or laparoscopically) and distinguish it from LAVH (where any part of the procedure other than vaginal cuff closure is performed vaginally).

History

Protocol first published: Issue 2, 2002
Review first published: Issue 1, 2005

Date	Event	Description
20 October 2014	New search has been performed	The addition of new studies has led to a change in the conclusions of this review.
20 October 2014	New citation required and conclusions have changed	This review has been updated. We have included 17 new studies (Candiani 2009; Chakraborty 2011; Chen 2011; Ghezzi 2010; Ghezzi 2011; Jung 2011; Kongwattanakul 2012; Paraiso 2013; Roy 2011; Roy 2012; Sarlos 2012; Sesti 2008a; Sesti 2008b; Song 2013; Nieboer 2012; Persson 2006; Zhu 2009). Some of the conclusions have changed. We have included three new types of intervention in the review; these have emerged as new approaches to hysterectomy in randomised controlled trials, i.e. robot‐assisted hysterectomy, mini laparoscopic hysterectomy and single‐port laparoscopic hysterectomy. We have excluded Drahonovsky 2006 and Morelli 2007 in this update of the review.
12 February 2009	New citation required and conclusions have changed	New authors: Theodoor E Nieboer, Sabine van Voorst, Ben Willem J Mol, Kirsten B Kluivers. Seven new studies were included. The following comparisons became statistically significant in the update: a shorter operation time in LAVH compared to TLH; more substantial bleeding in LH compared to VH; more febrile episodes or unspecified infections in TLH compared to LAVH; higher score on subscale vitality after LH compared to AH; higher satisfaction in VH compared to AH. New comparison: TLH versus LAVH.
9 June 2008	Amended	Converted to new review format.
5 February 2008	New citation required and conclusions have changed	Substantive amendment.

Appendices

Appendix 1. Cochrane Gynaecology and Fertility (CGF) Group specialised register search strategy

ProCite platform

Searched 1 December 2022

Keywords CONTAINS "Hysterectomy" or "Hysterectomy, abdominal" or "Hysterectomy, Vaginal" or "hysterectomy ‐laparoscopic" or "hysterectomy, laparoscopically assisted vaginal" or "Hysterectomy, subtotal" or "hysterectomy techniques" or "laparoscopic assisted vaginal hysterectomy" or "laparoscopic hysterectomy" or "LAVH" or "TVH" or "TLH" or "vaginal hysterectomy" or "abdominal hysterectomy" or "abdominal myomectomy" or "laparoscopic" or "laparoscopic procedure" or "laparoscopic surgical treatment" or "laparoscopically assisted hysterectomy" or "laparoscopically assisted vaginal hysterectomy" or "laparoscopy" or "laparotomy" or "mini‐laparoscopy" or "mini‐laparotomy" or "abdominal hysterectomy" or "robotic control" or "robotic hysterectomy" or Title CONTAINS "Hysterectomy" or "Hysterectomy, abdominal" or "Hysterectomy, Vaginal" or "hysterectomy ‐laparoscopic" or "hysterectomy, laparoscopically assisted vaginal" or "Hysterectomy, subtotal" or "hysterectomy techniques"

(2723 records )

Appendix 2. CENTRAL search strategy

Web Platform via Cochrane Register of Studies online (CRSO)

Searched 1 December 2022

#1 MESH DESCRIPTOR Hysterectomy EXPLODE ALL TREES 1865
#2 hysterectom*:TI,AB,KY 6853
#3 (excis* adj3 uterus):TI,AB,KY 1
#4 #1 OR #2 OR #3 6854
#5 abdomin*:TI,AB,KY 44571
#6 vagina*:TI,AB,KY 20178
#7 LAVH:TI,AB,KY 92
#8 LVH:TI,AB,KY 606
#9 (AH or VH or LH or LHa):TI,AB,KY 5784
#10 TLH:TI,AB,KY 201
#11 MESH DESCRIPTOR Laparoscopy EXPLODE ALL TREES 6323
#12 Laparoscop*:TI,AB,KY 22504
#13 minilaparoscop*:TI,AB,KY 60
#14 Robot*:TI,AB,KY 5866
#15 (four port ):TI,AB,KY 90
#16 (multiport or multi‐port):TI,AB,KY 173
#17 (single port):TI,AB,KY 374
#18 route*:TI,AB,KY 26507
#19 technique*:TI,AB,KY 99186
#20 MESH DESCRIPTOR Laparotomy EXPLODE ALL TREES 757
#21 laparotom*:TI,AB,KY 3627
#22 minilaparotom*:TI,AB,KY 136
#23 #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 204770
#24 #4 AND #23 4636

Appendix 3. MEDLINE search strategy

Ovid platform

Searched from 1946 to 1 December 2022

1 exp HYSTERECTOMY/ (33353)
2 hysterectom$.tw. (40533)
3 (excis$ adj3 uterus).tw. (111)
4 or/1‐3 (53210)
5 abdomin$.tw. (351751)
6 vaginal$.tw. (111725)
7 LAVH.tw. (414)
8 LVH.tw. (5764)
9 (AH or VH or LH or LHa).tw. (85634)
10 TLH.tw. (715)
11 exp Laparoscopy/ (114104)
12 minilaparoscop$.tw. (235)
13 Robot$.tw. (63487)
14 Laparoscop$.tw. (145837)
15 four port.tw. (395)
16 (multiport or multi‐port).tw. (1290)
17 single port.tw. (2884)
18 route$.tw. (213678)
19 technique$.tw. (1722384)
20 exp Laparotomy/ (20091)
21 laparotom$.tw. (53541)
22 minilaparotom$.tw. (1085)
23 or/5‐22 (2581564)
24 4 and 23 (24254)
25 randomized controlled trial.pt. (581680)
26 controlled clinical trial.pt. (95114)
27 randomized.ab. (583929)
28 placebo.tw. (239926)
29 clinical trials as topic.sh. (200614)
30 randomly.ab. (396455)
31 trial.ti. (274657)
32 (crossover or cross‐over or cross over).tw. (95846)
33 or/25‐32 (1523298)
34 exp animals/ not humans.sh. (5069761)
35 33 not 34 (1400184)
36 24 and 35 (2475)

Appendix 4. Embase search strategy

Ovid platform

Searched from 1980 to 1 December 2022

1 abdomin$.tw. (498520)
2 vaginal$.tw. (154629)
3 LAVH.tw. (765)
4 LVH.tw. (10822)
5 (Ah or Vh or Lh).tw. (97724)
6 TLH.tw. (1562)
7 exp Laparoscopy/ (186198)
8 Laparoscop$.tw. (233601)
9 minilaparoscop$.tw. (386)
10 technique$.tw. (2047560)
11 route$.tw. (252529)
12 Robot$.tw. (93486)
13 (multiport or multi‐port).tw. (2156)
14 single port.tw. (5444)
15 four port.tw. (573)
16 technique$.tw. (2047560)
17 exp Laparotomy/ (90343)
18 laparotom$.tw. (72017)
19 minilaparotom$.tw. (1387)
20 or/1‐19 (3210979)
21 exp HYSTERECTOMY/ or exp ABDOMINAL HYSTERECTOMY/ or exp VAGINAL HYSTERECTOMY/ (81474)
22 hysterectom$.tw. (62577)
23 (excis$ adj3 uterus).tw. (145)
24 or/21‐23 (91580)
25 20 and 24 (48207)
26 Clinical Trial/ (1038836)
27 Randomized Controlled Trial/ (733674)
28 exp randomization/ (95758)
29 Single Blind Procedure/ (48290)
30 Double Blind Procedure/ (197915)
31 Crossover Procedure/ (72033)
32 Placebo/ (374268)
33 Randomi?ed controlled trial$.tw. (300410)
34 Rct.tw. (49454)
35 random allocation.tw. (2395)
36 randomly allocated.tw. (42696)
37 allocated randomly.tw. (2826)
38 (allocated adj2 random).tw. (854)
39 Single blind$.tw. (29581)
40 Double blind$.tw. (228493)
41 ((treble or triple) adj blind$).tw. (1678)
42 placebo$.tw. (345713)
43 prospective study/ (809698)
44 or/26‐43 (2604102)
45 case study/ (89726)
46 case report.tw. (495103)
47 abstract report/ or letter/ (1212164)
48 or/45‐47 (1783130)
49 44 not 48 (2542091)
50 25 and 49 (6230)

Appendix 5. PsycINFO search strategy

Ovid platform

Searched from 1806 to 1 December 2022

1 exp Hysterectomy/ (473)
2 hysterectom$.tw. (868)
3 or/1‐2 (892)
4 abdom$.tw. (7322)
5 vaginal$.tw. (5612)
6 (lap$ adj assist$).tw. (14)
7 (lap$ adj5 vaginal$).tw. (17)
8 LAVH.tw. (2)
9 LVH.tw. (37)
10 Laparoscop$.tw. (574)
11 route$.tw. (17810)
12 technique$.tw. (210009)
13 approach$.tw. (621165)
14 or/4‐13 (812182)
15 3 and 14 (209)
16 random.tw. (67022)
17 control.tw. (494517)
18 double‐blind.tw. (24599)
19 clinical trials/ (12125)
20 placebo/ (6368)
21 exp Treatment/ (1167856)
22 or/16‐21 (1606524)
23 15 and 22 (176)

Appendix 6. CINAHL search strategy

Ebsco platform

Searched from 1961 to 8 January 2020

#	Query	Results
S37	S22 AND S36	1,131
S36	S23 OR S24 or S25 or S26 OR S27 OR S28 OR S29 OR S30 OR S31 OR S32 OR S33 OR S34 OR S35	1,372,403
S35	TX allocat* random*	11,308
S34	(MH "Quantitative Studies")	24,115
S33	(MH "Placebos")	11,559
S32	TX placebo*	60,526
S31	TX random* allocat*	11,308
S30	(MH "Random Assignment")	56,787
S29	TX randomi* control* trial*	180,912
S28	TX ( (singl* n1 blind*) or (singl* n1 mask*) ) or TX ( (doubl* n1 blind*) or (doubl* n1 mask*) ) or TX ( (tripl* n1 blind*) or (tripl* n1 mask*) ) or TX ( (trebl* n1 blind*) or (trebl* n1 mask*) )	1,044,734
S27	TX ( (trebl* n1 blind*) or (trebl* n1 mask*) )	249
S26	TX ( (trebl* n1 blind*) or (trebl* n1 mask*) )	249
S25	TX clinic* n1 trial*	256,178
S24	PT Clinical trial	86,321
S23	(MH "Clinical Trials+")	271,788
S22	S3 AND S21	5,655
S21	S4 OR S5 OR S6 OR S7 OR S8 OR S9 OR S10 OR S11 OR S12 OR S13 OR S14 OR S15 OR S16 OR S17 OR S18 OR S19 OR S20	711,667
S20	TX minilaparotom*	125
S19	TX laparotom*	7,302
S18	(MM "Laparotomy")	1,184
S17	TX approach*	339,150
S16	TX technique*	280,878
S15	TX route*	18,849
S14	TX Laparoscop*	32,919
S13	(MM "Laparoscopy")	12,052
S12	TX TLH	180
S11	TX (Ah or Vh or Lh)	24,311
S10	TX LVH	934
S9	TX LAVH	58
S8	TX (lap* N2 vagina*)	489
S7	TX (lap* N2 assist*)	2,518
S6	TX vagina*	26,792
S5	(MM "Hysterectomy, Vaginal")	361
S4	TX abdomin*	63,218
S3	S1 OR S2	10,593
S2	TX Hysterectom*	10,593
S1	(MH "Hysterectomy+")	6,714

Appendix 7. Biological abstracts search strategy

Biological Abstracts (1969 to August 2008, not included in searches beyond 2008)

1 exp HYSTERECTOMY/ (0)
2 hysterectom$.tw. (10663)
3 1 or 2 (10663)
4 abdom$.tw. (149794)
5 vaginal$.tw. (31662)
6 (lap$ adj assist$).tw. (691)
7 (lap$ adj5 vaginal$).tw. (540)
8 LAVH.tw. (71)
9 LVH.tw. (1654)
10 Laparoscop$.tw. (16487)
11 route$.tw. (373620)
12 technique$.tw. (3259392)
13 approach$.tw. (354093)
14 laparo$.tw. (29111)
15 or/4‐14 (3796162)
16 3 and 15 (7312)
17 limit 16 to yr="2007 ‐ 2008" (529)
18 from 17 keep 1‐529 (529)

Appendix 8. Clinical Trials Register; clinicaltrials.gov search strategy

Web platform

Searched from inception to 1 December 2022

1. Hysterectomy
2. Abdominal
3. Vaginal
4. Laparoscopic assisted
5. Laparo‐vaginal
6. Laparoscopic
7. 1 and 2 or 3 or 4 or 5 or 6

Appendix 9. Data extraction

• Trial characteristics

  • Method of randomisation, in order of preference, as follows:

    • third party randomisation, for example by pharmacy, computer or telephone;

    • true randomisation by carer, for example by opaque numbered envelope or register;

    • not stated.

  • Study design:

    • blinding;

    • duration of follow‐up;

    • type of follow‐up.

  • Size of study:

    • number of women recruited;

    • number of women randomised;

    • number of women excluded;

    • number of women withdrawn and lost to follow‐up;

    • number of women analysed.

  • Study setting:

    • single‐centre or multicentre;

    • location;

    • timing and duration;

    • source of funding stated or not.

  • Analyses:

    • whether a power calculation was performed and adhered to;

    • whether 'intention‐to‐treat' analysis was performed by authors, was possible from the data but not performed by authors, not possible or uncertain.

  • Criteria for hysterectomy:

    • indications specified;

    • data broken down by indications for hysterectomy.

• Characteristics of the study participants

  • Baseline characteristics:

    • age;

    • parity;

    • indication for hysterectomy;

    • investigative work up, for example pelvic ultrasound scan, endometrial sampling;

    • previous treatments;

    • exclusion criteria.

  • Treatment characteristics:

    • pre‐operative preparation, for example pre‐operative medical treatment;

    • level of training of surgeons.

• Interventions

  • Approach to hysterectomy, percentage of patients having subtotal hysterectomy

  • Subcategory in case of LH (i.e. LAVH, LH(a) and TLH)

  • Use of technique to support the vaginal vault

  • Proportion undergoing bilateral elective oophorectomy versus ovarian conservation

  • Other strategies to reduce the likelihood of complications

  • Absence of co‐interventions in treatment and control groups

  • If the trial compared a surgical approach performed by one (group of) surgeon(s) with another surgical approach performed by a second (group of) surgeon(s)

• Outcomes

  • Primary outcomes:

  • 1. Return to normal activities

  • 2. Satisfaction and quality of life

  • 3. Intra‐operative visceral injury: bladder injury, ureter injury, urinary tract (bladder or ureter) injury, bowel injury, vascular injury

  • 4. Major long‐term complications: fistula, pelvic‐abdominal pain, urinary dysfunction, bowel dysfunction, pelvic floor condition (prolapse), sexual dysfunction

  • Secondary outcomes:

  • 5. Operation time

  • 6. Other intra‐operative complication: estimated blood loss, (sequelae of) bleeding, including substantial bleeding, haemoglobin or haematocrit drop, transfusion, pelvic haematoma, unintended laparotomy for approaches not involving routine laparotomy

  • 7. Short‐term outcomes and complications: length of hospital stay, infections: vaginal cuff, abdominal wall or wound, urinary tract infection, chest infection, febrile episodes or unspecified infections, thromboembolism, perioperative mortality, postoperative ileus, wound dehiscence, pain scales and pain relief

  • 8. Costs

Data and analyses

Comparison 1. VH versus AH.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Return to normal activities (days)	4	274	Mean Difference (IV, Random, 95% CI)	‐10.91 [‐17.95, ‐3.87]
1.2 Long‐term outcomes: satisfaction (dichotomous)	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.3 Intraoperative visceral injury (dichotomous)	9		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.3.1 Bladder injury	7	697	Odds Ratio (M‐H, Fixed, 95% CI)	1.62 [0.52, 4.99]
1.3.2 Ureter injury	3	277	Odds Ratio (M‐H, Fixed, 95% CI)	3.10 [0.12, 79.23]
1.3.3 Urinary tract (bladder or ureter) injury	9	901	Odds Ratio (M‐H, Fixed, 95% CI)	1.73 [0.65, 4.63]
1.3.4 Bowel injury	4	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
1.3.5 Vascular injury	2	219	Odds Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.21]
1.4 Long‐term complications (dichotomous)	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.4.1 Urinary dysfunction	2	177	Odds Ratio (M‐H, Fixed, 95% CI)	3.20 [0.32, 31.90]
1.5 Operation time (mins)	7		Mean Difference (IV, Random, 95% CI)	Subtotals only
1.5.1 VH versus AH	7	594	Mean Difference (IV, Random, 95% CI)	‐19.02 [‐46.80, 8.75]
1.6 Short‐term outcomes (dichotomous)	11		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.6.1 Transfusion	9	852	Odds Ratio (M‐H, Fixed, 95% CI)	0.78 [0.44, 1.38]
1.6.2 Pelvic haematoma	7	694	Odds Ratio (M‐H, Fixed, 95% CI)	1.11 [0.45, 2.78]
1.6.3 Vaginal cuff infection	3	216	Odds Ratio (M‐H, Fixed, 95% CI)	3.14 [0.48, 20.55]
1.6.4 Wound/abdominal wall infection	6	628	Odds Ratio (M‐H, Fixed, 95% CI)	0.18 [0.06, 0.53]
1.6.5 UTI	5	350	Odds Ratio (M‐H, Fixed, 95% CI)	0.52 [0.14, 1.97]
1.6.6 Chest infection	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.13, 7.60]
1.6.7 Febrile episodes or unspecified infection	6	593	Odds Ratio (M‐H, Fixed, 95% CI)	0.59 [0.35, 1.01]
1.6.8 Thromboembolism	2	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
1.7 Length of hospital stay (days)	7	570	Mean Difference (IV, Random, 95% CI)	‐1.57 [‐2.11, ‐1.03]
1.8 All outcomes, descriptive data	9		Other data	No numeric data
1.8.1 Quality of life (descriptive data)	1		Other data	No numeric data
1.8.2 Operation time (descriptive data)	5		Other data	No numeric data
1.8.3 Length of hospital stay (descriptive data)	5		Other data	No numeric data
1.8.4 Urinary and sexual dysfunction (descriptive data)	1		Other data	No numeric data
1.8.5 Cost (descriptive data)	2		Other data	No numeric data

Comparison 2. LH versus AH.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Return to normal activities (days)	7	618	Mean Difference (IV, Random, 95% CI)	‐13.01 [‐16.47, ‐9.56]
2.1.1 LAVH vs AH	3	288	Mean Difference (IV, Random, 95% CI)	‐12.20 [‐18.55, ‐5.86]
2.1.2 TLH vs AH	4	330	Mean Difference (IV, Random, 95% CI)	‐14.33 [‐17.92, ‐10.75]
2.2 Satisfaction	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.2.1 LH (method unspecified) versus AH	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2.3 Bladder injury	15	2298	Odds Ratio (M‐H, Fixed, 95% CI)	1.68 [0.88, 3.22]
2.3.1 LAVH versus AH	6	723	Odds Ratio (M‐H, Fixed, 95% CI)	1.70 [0.49, 5.88]
2.3.2 TLH versus AH	5	359	Odds Ratio (M‐H, Fixed, 95% CI)	0.54 [0.13, 2.19]
2.3.3 LH (method unspecified) versus AH	4	1216	Odds Ratio (M‐H, Fixed, 95% CI)	2.87 [1.02, 8.07]
2.4 Ureter injury	10	1675	Odds Ratio (M‐H, Fixed, 95% CI)	3.62 [1.18, 11.11]
2.4.1 TLH versus AH	6	459	Odds Ratio (M‐H, Fixed, 95% CI)	3.93 [0.81, 19.15]
2.4.2 LH (method unspecified) versus AH	4	1216	Odds Ratio (M‐H, Fixed, 95% CI)	3.36 [0.69, 16.31]
2.5 Urinary tract (bladder or ureter) injury	18	2594	Odds Ratio (M‐H, Fixed, 95% CI)	2.16 [1.19, 3.93]
2.5.1 LAVH versus AH	7	819	Odds Ratio (M‐H, Fixed, 95% CI)	1.34 [0.44, 4.10]
2.5.2 TLH versus AH	7	559	Odds Ratio (M‐H, Fixed, 95% CI)	1.73 [0.58, 5.15]
2.5.3 LH (method unspecified) versus AH	4	1216	Odds Ratio (M‐H, Fixed, 95% CI)	3.30 [1.24, 8.77]
2.6 Bowel injury	7	1431	Odds Ratio (M‐H, Fixed, 95% CI)	0.23 [0.05, 1.14]
2.6.1 LAVH versus AH	1	96	Odds Ratio (M‐H, Fixed, 95% CI)	0.30 [0.01, 7.56]
2.6.2 TLH versus AH	3	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
2.6.3 LH (method unspecified) versus AH	3	1116	Odds Ratio (M‐H, Fixed, 95% CI)	0.21 [0.03, 1.33]
2.7 Vascular injury	3	1056	Odds Ratio (M‐H, Fixed, 95% CI)	1.40 [0.48, 4.09]
2.7.1 LAVH versus AH	1	80	Odds Ratio (M‐H, Fixed, 95% CI)	5.26 [0.24, 113.11]
2.7.2 LH (method unspecified) versus AH	2	976	Odds Ratio (M‐H, Fixed, 95% CI)	1.06 [0.33, 3.44]
2.8 Fistula	2	245	Odds Ratio (M‐H, Fixed, 95% CI)	3.07 [0.32, 29.96]
2.8.1 LAVH versus AH	1	143	Odds Ratio (M‐H, Fixed, 95% CI)	3.09 [0.12, 77.01]
2.8.2 TLH versus AH	1	102	Odds Ratio (M‐H, Fixed, 95% CI)	3.06 [0.12, 76.88]
2.9 Urinary dysfunction	3	343	Odds Ratio (M‐H, Fixed, 95% CI)	0.94 [0.49, 1.82]
2.9.1 LAVH versus AH	1	80	Odds Ratio (M‐H, Fixed, 95% CI)	3.08 [0.12, 77.80]
2.9.2 LH (method unspecified) versus AH	1	166	Odds Ratio (M‐H, Fixed, 95% CI)	0.88 [0.44, 1.76]
2.9.3 TLH versus AH	1	97	Odds Ratio (M‐H, Fixed, 95% CI)	1.02 [0.06, 16.81]
2.10 Operation time (mins)	15		Mean Difference (IV, Random, 95% CI)	Subtotals only
2.10.1 LAVH versus AH	9	910	Mean Difference (IV, Random, 95% CI)	23.16 [‐4.04, 50.35]
2.10.2 TLH versus AH	5	393	Mean Difference (IV, Random, 95% CI)	19.75 [7.94, 31.55]
2.10.3 LH (method unspecified) versus AH	1	100	Mean Difference (IV, Random, 95% CI)	14.80 [7.36, 22.24]
2.11 Bleeding	6	1366	Odds Ratio (M‐H, Fixed, 95% CI)	0.46 [0.19, 1.10]
2.11.1 LAVH versus AH	3	340	Odds Ratio (M‐H, Fixed, 95% CI)	0.33 [0.07, 1.66]
2.11.2 TLH versus AH	1	50	Odds Ratio (M‐H, Fixed, 95% CI)	0.18 [0.01, 4.04]
2.11.3 LH (method unspecified) versus AH	2	976	Odds Ratio (M‐H, Fixed, 95% CI)	0.67 [0.21, 2.12]
2.12 Transfusion	23	2911	Odds Ratio (M‐H, Random, 95% CI)	0.58 [0.34, 0.99]
2.12.1 LAVH versus AH	13	1194	Odds Ratio (M‐H, Random, 95% CI)	0.41 [0.22, 0.77]
2.12.2 TLH versus AH	7	601	Odds Ratio (M‐H, Random, 95% CI)	0.61 [0.24, 1.53]
2.12.3 LH (method unspecified) versus AH	3	1116	Odds Ratio (M‐H, Random, 95% CI)	0.91 [0.08, 9.85]
2.13 Pelvic haematoma	10	938	Odds Ratio (M‐H, Fixed, 95% CI)	0.69 [0.36, 1.33]
2.13.1 LAVH versus AH	8	778	Odds Ratio (M‐H, Fixed, 95% CI)	0.73 [0.36, 1.52]
2.13.2 TLH versus AH	2	160	Odds Ratio (M‐H, Fixed, 95% CI)	0.56 [0.13, 2.37]
2.14 Length of hospital stay (days)	13		Mean Difference (IV, Random, 95% CI)	Subtotals only
2.14.1 LAVH versus AH	8	870	Mean Difference (IV, Random, 95% CI)	‐2.39 [‐3.20, ‐1.59]
2.14.2 TLH versus AH	4	333	Mean Difference (IV, Random, 95% CI)	‐2.07 [‐3.29, ‐0.84]
2.14.3 LH (method unspecified) versus AH	1	100	Mean Difference (IV, Random, 95% CI)	‐43.04 [‐44.39, ‐41.69]
2.15 Vaginal cuff infection	9	852	Odds Ratio (M‐H, Fixed, 95% CI)	1.43 [0.67, 3.04]
2.15.1 LAVH versus AH	6	698	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.42, 2.38]
2.15.2 TLH versus AH	3	154	Odds Ratio (M‐H, Fixed, 95% CI)	4.81 [0.77, 29.89]
2.16 Wound/abdominal wall infection	9	824	Odds Ratio (M‐H, Fixed, 95% CI)	0.21 [0.10, 0.45]
2.16.1 LAVH versus AH	4	286	Odds Ratio (M‐H, Fixed, 95% CI)	0.20 [0.06, 0.65]
2.16.2 TLH versus AH	3	248	Odds Ratio (M‐H, Fixed, 95% CI)	0.39 [0.09, 1.68]
2.16.3 LH (method unspecified) versus AH	2	290	Odds Ratio (M‐H, Fixed, 95% CI)	0.13 [0.03, 0.57]
2.17 Urinary tract infection	9	757	Odds Ratio (M‐H, Fixed, 95% CI)	1.15 [0.61, 2.16]
2.17.1 LAVH versus AH	4	315	Odds Ratio (M‐H, Fixed, 95% CI)	0.98 [0.39, 2.50]
2.17.2 TLH versus AH	3	202	Odds Ratio (M‐H, Fixed, 95% CI)	2.36 [0.58, 9.58]
2.17.3 LH (method unspecified) versus AH	2	240	Odds Ratio (M‐H, Fixed, 95% CI)	0.84 [0.26, 2.69]
2.18 Chest infection	3	294	Odds Ratio (M‐H, Fixed, 95% CI)	0.31 [0.07, 1.35]
2.18.1 TLH versus AH	2	104	Odds Ratio (M‐H, Fixed, 95% CI)	0.63 [0.10, 3.93]
2.18.2 LH (method not specified) versus AH	1	190	Odds Ratio (M‐H, Fixed, 95% CI)	0.11 [0.01, 2.01]
2.19 Febrile episodes or unspecified infection	18	2386	Odds Ratio (M‐H, Fixed, 95% CI)	0.65 [0.49, 0.85]
2.19.1 LAVH versus AH	8	685	Odds Ratio (M‐H, Fixed, 95% CI)	0.49 [0.28, 0.86]
2.19.2 TLH versus AH	6	485	Odds Ratio (M‐H, Fixed, 95% CI)	0.39 [0.21, 0.72]
2.19.3 LH (method unspecified) versus AH	4	1216	Odds Ratio (M‐H, Fixed, 95% CI)	0.88 [0.61, 1.27]
2.20 Thromboembolism	4	1225	Odds Ratio (M‐H, Fixed, 95% CI)	1.10 [0.33, 3.71]
2.20.1 TLH versus AH	2	159	Odds Ratio (M‐H, Fixed, 95% CI)	1.09 [0.15, 8.06]
2.20.2 LH (method unspecified) versus AH	2	1066	Odds Ratio (M‐H, Fixed, 95% CI)	1.11 [0.24, 5.13]
2.21 Wound dehiscence	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.21.1 LAVH versus AH	2	181	Odds Ratio (M‐H, Fixed, 95% CI)	0.33 [0.07, 1.63]
2.22 Return to normal activities (descriptive data)	0		Other data	No numeric data
2.23 Long‐term outcomes: quality of life (descriptive data)	0		Other data	No numeric data
2.24 Operation time (descriptive data)	0		Other data	No numeric data
2.25 Length of hospital stay (descriptive data)	0		Other data	No numeric data
2.26 Cost (descriptive data)	0		Other data	No numeric data
2.27 Urinary and sexual dysfunction (descriptive data)	0		Other data	No numeric data

2.22. Analysis.

Comparison 2: LH versus AH, Outcome 22: Return to normal activities (descriptive data)

Return to normal activities (descriptive data)
Study	LH	AH	Comments
Langebrekke 1996	n = 46 median = 19.5 days range (0 to 140)	n = 54 median = 36.5 days range (23 to 259)	P value < 0.001 Wilcoxon rank‐sum test
Persson 2006	n = 63 median = 26 days range (3 to 86)	n = 56 median = 33.5 days range (14 to 61)	P value = 0.0081
Raju 1994	n = 40 median = 21 days range = (7 to 35)	n = 40 median = 42 days range (21 to 67)	P value < 0.0001 Mann‐Whitney U test
Schütz 2002	n = 28 median = 42 days	n = 20 median = 42 days	—

Comparison 3. LH versus VH.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Return to normal activities (days)	3	238	Mean Difference (IV, Fixed, 95% CI)	‐1.06 [‐4.18, 2.05]
3.1.1 LAVH versus VH	1	80	Mean Difference (IV, Fixed, 95% CI)	‐1.60 [‐5.11, 1.91]
3.1.2 TLH versus VH	2	158	Mean Difference (IV, Fixed, 95% CI)	0.88 [‐5.82, 7.59]
3.2 Ureter injury	4	846	Odds Ratio (M‐H, Fixed, 95% CI)	0.69 [0.09, 5.43]
3.2.1 LAVH versus VH	2	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
3.2.2 TLH versus VH	2	105	Odds Ratio (M‐H, Fixed, 95% CI)	0.32 [0.01, 8.24]
3.2.3 LH (method unspecified) versus VH	1	504	Odds Ratio (M‐H, Fixed, 95% CI)	1.51 [0.06, 37.18]
3.3 Bladder injury	10	1237	Odds Ratio (M‐H, Fixed, 95% CI)	0.93 [0.37, 2.33]
3.3.1 LAVH versus VH	6	503	Odds Ratio (M‐H, Fixed, 95% CI)	1.22 [0.34, 4.30]
3.3.2 TLH versus VH	3	185	Odds Ratio (M‐H, Fixed, 95% CI)	0.32 [0.01, 8.26]
3.3.3 LH (method unspecified) versus VH	2	549	Odds Ratio (M‐H, Fixed, 95% CI)	0.83 [0.18, 3.79]
3.4 Urinary tract (bladder or ureter) injury	13	1536	Odds Ratio (M‐H, Fixed, 95% CI)	0.92 [0.40, 2.09]
3.4.1 LAVH versus VH	8	670	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.32, 3.16]
3.4.2 TLH versus VH	5	317	Odds Ratio (M‐H, Fixed, 95% CI)	0.59 [0.08, 4.61]
3.4.3 LH (method unspecified) versus VH	2	549	Odds Ratio (M‐H, Fixed, 95% CI)	1.01 [0.23, 4.38]
3.5 Bowel injury	5	986	Odds Ratio (M‐H, Fixed, 95% CI)	3.26 [0.13, 82.16]
3.5.1 LAVH versus VH	3	332	Odds Ratio (M‐H, Fixed, 95% CI)	3.26 [0.13, 82.16]
3.5.2 TLH versus VH	2	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
3.5.3 LH (method unspecified) versus VH	1	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
3.6 Vascular injury	5	785	Odds Ratio (M‐H, Fixed, 95% CI)	1.58 [0.48, 5.27]
3.6.1 LAVH versus VH	2	136	Odds Ratio (M‐H, Fixed, 95% CI)	2.89 [0.11, 74.15]
3.6.2 TLH versus VH	1	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
3.6.3 LH (method unspecified) versus VH	2	549	Odds Ratio (M‐H, Fixed, 95% CI)	1.42 [0.39, 5.22]
3.7 Fistula	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.7.1 LAVH versus VH	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.8 Urinary dysfunction	3	248	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.25, 4.07]
3.8.1 LAVH versus VH	1	80	Odds Ratio (M‐H, Fixed, 95% CI)	3.08 [0.12, 77.80]
3.8.2 TLH versus VH	2	168	Odds Ratio (M‐H, Fixed, 95% CI)	0.71 [0.14, 3.66]
3.9 Operation time (mins)	14		Mean Difference (IV, Random, 95% CI)	Subtotals only
3.9.1 LAVH versus VH	12	905	Mean Difference (IV, Random, 95% CI)	41.32 [32.70, 49.94]
3.9.2 TLH versus VH	3	192	Mean Difference (IV, Random, 95% CI)	41.89 [‐5.52, 89.31]
3.10 Bleeding	4	806	Odds Ratio (M‐H, Fixed, 95% CI)	1.37 [0.29, 6.39]
3.10.1 LAVH versus VH	3	257	Odds Ratio (M‐H, Fixed, 95% CI)	1.24 [0.15, 10.03]
3.10.2 TLH versus VH	1	45	Odds Ratio (M‐H, Fixed, 95% CI)	1.58 [0.06, 41.03]
3.10.3 LH (method unspecified) versus VH	1	504	Odds Ratio (M‐H, Fixed, 95% CI)	1.51 [0.06, 37.18]
3.11 Transfusion	14	1586	Odds Ratio (M‐H, Fixed, 95% CI)	1.25 [0.76, 2.06]
3.11.1 LAVH versus VH	9	647	Odds Ratio (M‐H, Fixed, 95% CI)	1.50 [0.63, 3.58]
3.11.2 TLH versus VH	6	435	Odds Ratio (M‐H, Fixed, 95% CI)	0.88 [0.41, 1.91]
3.11.3 LH (method unspecified) versus VH	1	504	Odds Ratio (M‐H, Fixed, 95% CI)	1.74 [0.63, 4.79]
3.12 Pelvic haematoma	6	463	Odds Ratio (M‐H, Fixed, 95% CI)	0.86 [0.30, 2.51]
3.12.1 LAVH versus VH	5	403	Odds Ratio (M‐H, Fixed, 95% CI)	1.21 [0.36, 4.03]
3.12.2 TLH versus VH	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	0.19 [0.01, 4.06]
3.13 Unintended laparotomy	13	1414	Odds Ratio (M‐H, Fixed, 95% CI)	1.40 [0.72, 2.71]
3.13.1 LAVH versus VH	10	688	Odds Ratio (M‐H, Fixed, 95% CI)	4.11 [1.25, 13.52]
3.13.2 TLH versus VH	3	177	Odds Ratio (M‐H, Fixed, 95% CI)	0.70 [0.09, 5.58]
3.13.3 LH (method unspecified) versus VH	2	549	Odds Ratio (M‐H, Fixed, 95% CI)	0.67 [0.26, 1.74]
3.14 Vaginal cuff infection	4	276	Odds Ratio (M‐H, Fixed, 95% CI)	0.98 [0.22, 4.39]
3.14.1 LAVH versus VH	3	216	Odds Ratio (M‐H, Fixed, 95% CI)	0.98 [0.22, 4.39]
3.14.2 TLH versus VH	1	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
3.15 Wound/abdominal wall infection	4	363	Odds Ratio (M‐H, Fixed, 95% CI)	1.41 [0.28, 7.03]
3.15.1 LAVH versus VH	3	220	Odds Ratio (M‐H, Fixed, 95% CI)	2.88 [0.31, 27.06]
3.15.2 TLH versus VH	2	143	Odds Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.22]
3.16 Urinary tract infection	4	328	Odds Ratio (M‐H, Fixed, 95% CI)	2.12 [0.60, 7.50]
3.16.1 LAVH versus VH	2	125	Odds Ratio (M‐H, Fixed, 95% CI)	1.02 [0.15, 6.89]
3.16.2 TLH versus VH	3	203	Odds Ratio (M‐H, Fixed, 95% CI)	3.60 [0.59, 21.83]
3.17 Chest infection	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.17.1 TLH versus VH	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.18 Febrile episodes or unspecified infection	12	1508	Odds Ratio (M‐H, Fixed, 95% CI)	0.81 [0.53, 1.24]
3.18.1 LAVH versus VH	8	653	Odds Ratio (M‐H, Fixed, 95% CI)	1.50 [0.65, 3.47]
3.18.2 TLH versus VH	5	351	Odds Ratio (M‐H, Fixed, 95% CI)	0.36 [0.10, 1.29]
3.18.3 LH (method unspecified) versus VH	1	504	Odds Ratio (M‐H, Fixed, 95% CI)	0.72 [0.41, 1.25]
3.19 Thromboembolism	3	664	Odds Ratio (M‐H, Fixed, 95% CI)	1.38 [0.28, 6.88]
3.19.1 TLH versus VH	2	160	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.14, 7.24]
3.19.2 LH (method unspecified) versus VH	1	504	Odds Ratio (M‐H, Fixed, 95% CI)	2.52 [0.12, 52.76]
3.20 Length of hospital stay (days)	11	912	Mean Difference (IV, Random, 95% CI)	0.65 [0.45, 0.85]
3.20.1 LAVH versus VH	10	780	Mean Difference (IV, Random, 95% CI)	0.62 [0.40, 0.83]
3.20.2 TLH versus VH	2	132	Mean Difference (IV, Random, 95% CI)	0.58 [‐0.90, 2.06]
3.21 Return to normal activities (descriptive data)	0		Other data	No numeric data
3.22 Long‐term outcomes: quality of life (descriptive data)	0		Other data	No numeric data
3.23 Operation time (descriptive data)	0		Other data	No numeric data
3.24 Length of hospital stay (descriptive data)	0		Other data	No numeric data
3.25 Cost (descriptive data)	0		Other data	No numeric data
3.26 Urinary and sexual dysfunction (descriptive data)	0		Other data	No numeric data

3.24. Analysis.

Comparison 3: LH versus VH, Outcome 24: Length of hospital stay (descriptive data)

Length of hospital stay (descriptive data)
Study	LH	VH	Comments
Allam 2015	n = 30 median 0.75 days IQR 0.5 to 1.5 days	n = 30 median 1.5 IQR 1.5 to 2 days	Estimated with the Kruskal–Wallis test P < 0.001
Ekanayake 2021	n = 49 Median = 2 days IQR (1 to 3)	n = 49 Median = 3 days IQR (2 to 3)	TLH vs NDVH Not tested separately
Hwang 2002	n = 30 median = 4.7 days range (3 to 7)	n = 30 median = 4.7 days range (3 to 7)	Not tested separately
Nanavati 2016	n = 50 mean 4.5 days no IQR/SD given	n = 50 mean 4 days no IQR/SD given	No IQR/SD given no P value
Richardson 1995	n = 22 mean = 3.2 days range (2 to 7)	n = 23 mean = 3.3 days range (1 to 18)	—
Roy 2011	TLH: n = 30 median = 2 days min‐max = 2 to 12 days LAVH: n = 30 median = 3 days min‐max = 4 days	VH: n = 30 median = 2 days min‐max = 1 to 4 days	P value = 0.15
Roy 2012	n = 10 median = 3 days min‐max = 2 to 4 days	n = 10 median = 2 days min‐max = 2 to 4 days	Not statistically significant

Comparison 4. RH versus LH.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Return to normal activities (days)	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
4.2 Intraoperative visceral injury (dichotomous)	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.2.1 Ureter injury	1	100	Odds Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.21]
4.2.2 Vascular injury	1	100	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.06, 16.44]
4.3 Operation time	2	152	Mean Difference (IV, Random, 95% CI)	44.09 [5.31, 82.88]
4.4 Bleeding	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.4.1 Bleeding	1	144	Odds Ratio (M‐H, Fixed, 95% CI)	0.08 [0.00, 1.56]
4.5 Wound dehiscence	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.5.1 Wound dehiscence	2	244	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.17, 5.86]
4.6 Transfusion	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.7 Wound/abdominal wall infection	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.7.1 Wound/abdominal wall infection	2	244	Odds Ratio (M‐H, Fixed, 95% CI)	0.60 [0.08, 4.57]
4.8 Febrile episodes or unspecified infections	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
4.9 Operation time (descriptive data)	0		Other data	No numeric data
4.10 Return to normal activities (descriptive data)	0		Other data	No numeric data

Comparison 5. SP‐LH versus LH.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Bladder injury	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
5.1.1 SP‐TLH versus TLH	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
5.2 Ureter injury	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
5.3 Conversion or aditional port placement	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
5.4 Transfusion	6	552	Odds Ratio (M‐H, Fixed, 95% CI)	0.78 [0.34, 1.77]
5.4.1 SP‐LAVH versus LAVH	3	390	Odds Ratio (M‐H, Fixed, 95% CI)	0.58 [0.23, 1.47]
5.4.2 SP‐TLH versus TLH	3	162	Odds Ratio (M‐H, Fixed, 95% CI)	3.30 [0.33, 32.63]
5.5 Pelvic haematoma	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
5.5.1 SP‐LAVH versus LAVH	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
5.6 Wound/abdominal wall infection	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
5.6.1 SP‐LAVH versus LAVH	3	411	Odds Ratio (M‐H, Fixed, 95% CI)	1.03 [0.20, 5.15]
5.7 Febrile episodes or unspecified infection	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
5.7.1 SP‐LH versus LH	2	315	Odds Ratio (M‐H, Fixed, 95% CI)	2.56 [0.70, 9.44]
5.8 Vaginal cuff dehiscence	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
5.9 Postoperative ileus	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
5.9.1 SP‐TLH versus TLH	1	64	Odds Ratio (M‐H, Fixed, 95% CI)	2.36 [0.20, 27.39]
5.10 Operation time (mins)	4	262	Mean Difference (IV, Fixed, 95% CI)	14.95 [7.53, 22.38]
5.10.1 SP‐LAVH versus LAVH	1	100	Mean Difference (IV, Fixed, 95% CI)	‐5.00 [‐17.65, 7.65]
5.10.2 SP‐TLH versus TLH	3	162	Mean Difference (IV, Fixed, 95% CI)	25.43 [16.26, 34.59]
5.11 Length of hospital stay (days)	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
5.11.1 SP‐LAVH versus LAVH	1	100	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.49, 0.09]
5.12 Operation time (descriptive data)	0		Other data	No numeric data
5.13 Length of hospital stay (descriptive data)	0		Other data	No numeric data
5.14 Cost (descriptive data)	0		Other data	No numeric data

5.14. Analysis.

Comparison 5: SP‐LH versus LH, Outcome 14: Cost (descriptive data)

Cost (descriptive data)
Study	Description	SP‐LH	MP‐LH
Chung 2015	Cost of trocars used for SP‐LH and MP‐LH. No description of reported measure (mean or median). Units of currency = US dollars (USD)	n = 29 257 USD	n = 29 265 USD

Comparison 6. TLH versus LAVH.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 Intraoperative visceral injury (dichotomous)	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
6.1.1 Bladder injury	2	161	Odds Ratio (M‐H, Fixed, 95% CI)	0.72 [0.06, 8.27]
6.1.2 Ureter injury	2	161	Odds Ratio (M‐H, Fixed, 95% CI)	3.03 [0.27, 34.52]
6.1.3 Urinary tract (bladder or ureter) injury	3	233	Odds Ratio (M‐H, Fixed, 95% CI)	1.50 [0.29, 7.83]
6.1.4 Bowel injury	2	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
6.1.5 Vascular injury	1	101	Odds Ratio (M‐H, Fixed, 95% CI)	1.48 [0.09, 24.27]
6.2 Long‐term complications (dichotomous)	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
6.2.1 Dyspareunia	1	101	Odds Ratio (M‐H, Fixed, 95% CI)	2.64 [0.59, 11.72]
6.2.2 Orgasm (< 1 of 3)	1	101	Odds Ratio (M‐H, Fixed, 95% CI)	0.84 [0.38, 1.86]
6.3 Operation time (mins)	2	173	Mean Difference (IV, Fixed, 95% CI)	23.36 [12.50, 34.22]
6.4 Unintended laparotomy	3		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
6.4.1 Conversion to laparotomy	3	236	Odds Ratio (M‐H, Fixed, 95% CI)	1.28 [0.21, 7.85]
6.5 Short‐term outcomes (dichotomous)	3	687	Odds Ratio (M‐H, Random, 95% CI)	0.58 [0.28, 1.18]
6.5.1 Transfusion	3	233	Odds Ratio (M‐H, Random, 95% CI)	0.72 [0.18, 2.83]
6.5.2 Vaginal cuff infection	1	101	Odds Ratio (M‐H, Random, 95% CI)	0.28 [0.03, 2.45]
6.5.3 Abdominal wall/wound infection	1	60	Odds Ratio (M‐H, Random, 95% CI)	0.19 [0.01, 4.06]
6.5.4 UTI	1	60	Odds Ratio (M‐H, Random, 95% CI)	1.00 [0.13, 7.60]
6.5.5 Febrile episodes or unspecified infection	3	233	Odds Ratio (M‐H, Random, 95% CI)	0.61 [0.15, 2.45]
6.6 Length of hospital stay (days)	2	173	Mean Difference (IV, Fixed, 95% CI)	0.01 [‐0.35, 0.37]

Comparison 7. V‐NOTES versus LH.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
7.1 Conversion or additional port placement	2	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
7.1.1 V‐NOTES vs TLH	1	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
7.1.2 V‐NOTES vs SP‐LH	1	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
7.2 Operation time	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
7.3 Bladder injury	2	96	Odds Ratio (M‐H, Fixed, 95% CI)	3.09 [0.12, 78.41]
7.3.1 V‐NOTES vs TLH	1	70	Odds Ratio (M‐H, Fixed, 95% CI)	3.09 [0.12, 78.41]
7.3.2 V‐NOTES vs SP‐LH	1	0	Odds Ratio (M‐H, Fixed, 95% CI)	Not estimable
7.4 Febrile episodes or unspecified infection	2	96	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.17, 6.01]
7.4.1 V‐NOTES vs TLH	1	70	Odds Ratio (M‐H, Fixed, 95% CI)	0.49 [0.04, 5.61]
7.4.2 V‐NOTES vs SP‐LH	1	26	Odds Ratio (M‐H, Fixed, 95% CI)	3.24 [0.12, 87.13]
7.5 Length of hospital stay (days)	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
7.6 Substantial bleeding	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
7.7 Wound/abdominal wall infection	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
7.8 Operation time (descriptive data)	0		Other data	No numeric data
7.9 Length of hospital stay (descriptive data)	0		Other data	No numeric data

7.2. Analysis.

Comparison 7: V‐NOTES versus LH, Outcome 2: Operation time

7.9. Analysis.

Comparison 7: V‐NOTES versus LH, Outcome 9: Length of hospital stay (descriptive data)

Length of hospital stay (descriptive data)
Study	vNOTES	LH	Comments
Park 2021	n = 13 Median = 4 days Range (4 to 4)	n = 13 Median = 4 days Range (4 to 5)	P value = 0.762

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Agostini 2006.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: April 2002 to February 2004 (1 year, 10 months) Randomisation: computer‐generated allocation list Allocation concealment: numbered, sealed, opaque envelopes Blinding: no Number of women: 48 women Dropouts: there were no dropouts or conversions Follow‐up: women were followed up until 1 month after surgery; no loss to follow‐up Power calculationfor sample size: yes; 24 patients per group were necessary to detect a difference in complications between the 2 groups of 35% or more (25% versus 60% in VH(O) and LAVH(O) respectively) with 80% power and a significance level of 0.05 Analysis by intention‐to‐treat: yes (no conversions)
Participants	Mean age of 55 years in the VH(O) group and 53 years in the LAVH(O) group Inclusion criteria: women with benign disease, older than 45 years, uterine size below halfway pubis and umbilicus Exclusion criteria: virgin patient, contraindication pneumoperitoneum, adnexal mass
Interventions	VHO versus LAVHO VHO: standard VH technique with removal of ovaries and tubes as described by Ballard, or an endo loop if indicated LAVHO: laparoscopic dissection of suspensory ligaments and round ligaments, remainder of case done vaginally LAVH AAGL classification: type IB Both groups received prophylactic antibiotic treatment (cefoxitin IV) GA for both VHO and LAVHO Surgeons: 5 different surgeons experienced in vaginal surgery carried out both procedures
Outcomes	Primary outcome: complications (blood loss more than 500 mL, blood transfusion, haematoma, postoperative fever) Secondary outcomes: operative time; hospital stay
Notes	France University Hospital of Marseille Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated allocation list
Allocation concealment (selection bias)	Low risk	Numbered, sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no losses to follow‐up
Selective reporting (reporting bias)	Unclear risk	No clear primary outcome was defined
Other bias	Unclear risk	Surgeons' experience with laparoscopic procedures not reported

Allam 2015.

Study characteristics
Methods	Single‐centre, prospective, randomised controlled clinical trial Duration: May 2010 to February 2012 (22 months) Randomisation: randomisation was done using a computer‐generated system. Patients were randomised according to type of hysterectomy done into 3 groups: group 1 VH; group 2 TAH and group 3 TLH. Three staff member surgeons were also randomised to operate on the patients. Allocation concealment: sealed envelopes, which were opened 24 hours before surgery Blinding: not described Number of women: 90 patients were enrolled Follow‐up: 1 and 6 weeks after operation Power calculation for sample size: no
Participants	Mean age of participants was 54 in the VH group, 49.5 in the AH group and 54 in the TLH group Inclusion criteria: patients admitted from the gynaecologic outpatient clinic to undergo hysterectomy were enrolled Exclusion criteria: age < 40 years, large uterine size (16 weeks), malignant uterine pathology and contraindication for TLH (e.g. severe cardiac disease)
Interventions	AH versus VH versus TLH AH: performed using an electrosurgical bipolar vessel sealing (EBVS) device VH: performed using an EBVS device and the coring and bisection technique for larger uteri TLH: the procedure was performed with a McCartney tube in the vagina during culdotomy TLH cuff closure: the suture was introduced vaginally and the vagina closed laparoscopically. The suture was then dropped in the McCarney tube and the knot tied vaginally. All patients received spinal anaesthesia and preoperative Cefotax for antibiotic prophylaxis An intraperitoneal drain was left in all 3 groups Surgeons: 3 staff member surgeons performed all procedures Surgeon experience: all surgeons were equally competent in the 3 types of procedure
Outcomes	Operative time Operative blood loss Postoperative haemoglobin and haematocrit Operative complications Postoperative pain (VAS and the need for analgesics) Postoperative hospital stay duration Follow‐up: after 1 and 6 weeks for any further complications
Notes	Conducted at Ain‐shams University Maternity Hospital, Cairo, Egypt
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients and surgeons were randomly assigned using a computer‐generated system
Allocation concealment (selection bias)	Low risk	Sealed envelopes, which were opened 24 hours before surgery
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding performed
Incomplete outcome data (attrition bias) All outcomes	Low risk	All predefined outcome measures have been described; no dropouts/missing data
Selective reporting (reporting bias)	Low risk	No reporting bias identified
Other bias	Unclear risk	No long‐term follow‐up No sample size calculation reported This was an investigator‐driven study. No third party sources of funding.

Baekelandt 2019.

Study characteristics
Methods	Single‐centre study; parallel‐group design, 1:1 randomised, single‐blinded trial Duration: December 2015 to June 2017 (18 months) Randomisation: computer‐generated random number lists. Randomisation was stratified for uterine volume. Randomisation was performed by officer not otherwise involved in the study. Allocation concealment: sequentially numbered, sealed, opaque envelopes Blinding: 4 superficial non‐therapeutic skin incisions were made in all women of the V‐NOTES group, identical to those in the TLH group Number of women eligible and randomised = 70 (35 in each group) Dropouts: there were no dropouts Follow‐up: women were followed up until 6 weeks after surgery; no loss to follow‐up Power calculation for sample size: yes, 54 women were needed to demonstrate non‐inferiority of V‐NOTES versus TLH for the primary outcome (power 80%, alpha error 5%)
Participants	70 women with a mean age of 49 in the TLH group and 46 in the V‐NOTES group Inclusion criteria: women between 18 and 70 years were eligible for the study if they were scheduled to undergo hysterectomy for benign disease Exclusion criteria: women with a history of rectal surgery, suspected rectovaginal endometriosis, suspected malignancy, pelvic inflammatory disease (PID), active lower genital tract infection, virginity or pregnancy
Interventions	TLH versus V‐NOTES TLH: using the laparoscopic closed entry technique with the insertion of a Veress needle one 10 mm intra‐umbilical primary trocar and three 5 mm accessory trocars. A standard 10 mm rigid mm 30° laparoscope was used. A Hohl uterine manipulator was used. The hysterectomy was performed by dissecting cranially to caudally using bipolar coagulation. TLH cuff closure: the vaginal cuff was sutured laparoscopically using intracorporeal knot tying V‐NOTES: the surgeon created access to the peritoneal cavity by circumcising the cervix, performing an anterior and posterior colpotomy, and cutting the uterosacral ligaments as done in conventional vaginal surgery when possible (VANH technique: Vaginally Assisted NOTES Hysterectomy). If classical colpotomy was not possible: the surgeon used the V‐NOTES port and the endoscopic instruments to make an anterior or posterior incision in the vaginal vault (TVNH technique: Total Vaginal NOTES Hysterectomy). After obtaining access to the peritoneal cavity, a V‐NOTES port was inserted through the vagina into the peritoneal cavity to establish a pneumoperitoneum. T A standard 10 mm rigid mm 0° laparoscope was used through one trocar and two endoscopic instruments through the other two trocars. The surgeon performed the hysterectomy by dissecting caudally to cranially using endoscopic instruments with bipolar coagulation. At the end of the hysterectomy, the surgeon removed the V‐NOTES port and the uterus through the vagina. The vaginal cuff was closed similar to conventional vaginal surgery. At the end of all hysterectomies, a vaginal plug (Betadine gauze 10 cm x 5 cm) was left in place to be removed after 3 hours together with the Foley catheter. Cefazolin 2 g and metronidazole 1.5 g were administered intravenously at the beginning of each procedure. The care given by the anaesthesiologists and the nursing staff was standardised and similar in both groups. Surgeons: 1 surgeon performed all hysterectomies
Outcomes	Primary outcome: removal of the uterus according to the allocated technique Secondary outcomes: duration of the surgical procedure, the proportion of women leaving the hospital within 12 hours after surgery, length of hospital stay, total amount of analgesics used and the VAS pain scores measured twice daily during the first week following surgery
Notes	Patient‐reported outcomes used as a basis for sample size calculation Study in Belgium This trial was an investigator‐driven trial. Costs were paid by investigators and no funding by a pharmaceutical company.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random number lists
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	Low risk	Participants and personnel measuring outcomes were blinded. Surgeon was not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up, no dropouts. No conversions.
Selective reporting (reporting bias)	Low risk	No reporting bias identified
Other bias	Unclear risk	Patient‐reported outcomes used as a basis for sample size calculation This trial was an investigator‐driven trial. Costs were paid by investigators and no funding by a pharmaceutical company. All procedures done by 1 experienced surgeon

Benassi 2002.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: June 1997 to December 2000 (2 years, 6 months) Randomisation: computer‐selected randomisation Allocation concealment: not clearly described Blinding: no Number of womenrandomised: 119 Dropouts: no dropouts reported Follow‐up: no loss to follow‐up Power calculation: not reported
Participants	Mean age of 47 years for the AH group and 48 years for the VH group Inclusion criteria: women with symptomatic enlarged uteri (200 mL to 1300 mL) Exclusion criteria: prolapse, uterine or adnexal neoplasia, pelvic inflammation, vaginal stenosis, previous pelvic or vaginal procedures, hormonal treatment in the 6 months prior to surgery
Interventions	AH versus VH AH and VH performed according to Novak technique Perimenopausal patients also underwent bilateral oophorectomy Both groups received prophylactic antibiotic treatment (cefotaxime 2 g IV) and anticoagulant therapy with enoxaparin 2000 IU General anaesthetic for AH; spinal anaesthetic for VH Surgeons: the same surgeons carried out the surgery Surgeon experience: not reported
Outcomes	Operative time; operative complications (injury to major vessel, ureter, bladder and bowel); drop in haemoglobin; postoperative complications; hospital stay No clear primary or secondary outcomes
Notes	Italy University Hospital of Parma Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐selected randomisation
Allocation concealment (selection bias)	Unclear risk	Patients were randomly allocated, not clearly described
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Primary outcome not (pre)defined
Other bias	Unclear risk	No other bias identified. Surgeons' experience not reported.

Candiani 2009.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: April 2004 to April 2006 (2 years) Randomisation: computer‐generated Allocation concealment: sealed, opaque envelopes Blinding: none Number of women eligible = 95. Number of women randomised = 60 Follow‐up: in the 12‐month follow‐up, 7 patients in LH and 6 in VH were lost to follow‐up. There were no conversions. Power calculation was performed for sample size: 30 patients per group were necessary to detect a difference of more than 25% in discharge at day 2 (less than 5% versus more than 30% in VH and LH, respectively) with 80% power and a significance level of 0.05 Analysis by intention‐to‐treat: yes (no conversions)
Participants	Mean age of 49 years in the LH group and 51 in the VH group Inclusion criteria: women with an indication for vaginal hysterectomy for benign pathology Exclusion criteria: uterine volume greater than 300 mL, previous surgery for pelvic inflammatory disease or endometriosis, suspicion of malignancy, the presence of an ovarian cyst greater than 4 cm and a vaginal prolapse higher than first degree
Interventions	TLH versus VH TLH: total laparoscopic hysterectomy TLH cuff closure: laparoscopic closure with suspension to the uterosacral ligaments VH: following Heaney's technique Antibiotic treatment: prophylactic antibiotic treatment (type not mentioned) at the beginning of the surgery and repeated 12 hours later Surgeons: all the procedures were performed by 2 skilled surgeons Surgeons experience: only surgeons who had performed at least 50 procedures were involved
Outcomes	Primary outcome: hospital stay (with fixed parameters to discharge patients) Secondary outcomes: pain (as measured by VAS and analgesic request), blood loss and execution of adnexectomy if preoperatively planned
Notes	Italy San Paolo Hospital, University School of Medicine (Milan) Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated allocation list
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	Dropout and loss to follow‐up mentioned; no conversions. 10% lost to follow‐up
Selective reporting (reporting bias)	Low risk	Primary endpoint was clearly stated
Other bias	Low risk	No other bias identified

Chakraborty 2011.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: June 2006 to May 2008 (2 years) Randomisation: computer‐generated random numbers Allocation concealment: envelopes Blinding: no Number of women randomised = 200. No dropouts reported. No conversions mentioned Follow‐up: duration of follow‐up not mentioned. No loss to follow‐up. Power calculation for sample size: not reported Analysis by intention‐to‐treat: not reported
Participants	Age only mentioned in groups and not in means Inclusion criteria: women scheduled for hysterectomy for benign disease without uterine decent and a uterine size < 14 weeks gestational age Exclusion criteria: primary diagnosis related to cancer, pelvic endometriosis, adnexal pathology, multiple abdominal scar from previous surgery and prolapse
Interventions	VH versus AH VH: non‐descent vaginal hysterectomy The surgical technique is not described either for VH or for AH Use of prophylactic antibiotic treatment not reported Surgeons' experience not mentioned
Outcomes	Length of hospital stay, operating time, intra‐ and postoperative blood transfusion, minor and major complications
Notes	India Hospital New Raipur (Dabur Park) Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Computer‐generated random numbers were used for randomisation. While assigning groups to envelopes, if the computer‐generated random number was odd, the assigned group was A (non‐descent vaginal hysterectomy). If the random number was even, the envelope was assigned to group B: abdominal hysterectomy
Allocation concealment (selection bias)	Low risk	Assignments were placed in envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Insufficient information available
Other bias	Unclear risk	The distribution in age and parity between the groups is somewhat skewed. Surgeon's experience not reported

Chen 2011.

Study characteristics
Methods	Single‐centre study Duration: September 2009 to June 2010 Randomisation: computerised balanced method (1:1). Random numbers were computer‐generated Allocation concealment: random numbers were inserted in numbered, sealed and opaque envelopes. A single envelope was opened by the surgeon when the patient was hospitalised Blinding: no Number of women: assessed for eligibility = 118, randomised = 102 Follow‐up: single‐port LAVH ‐ no loss to follow‐up or dropout; multiple‐port LAVH ‐ 2 excluded from analysis, 0 lost to follow‐up ‐ 2 discontinued intervention Power calculation for sample size: yes, based on previous study of 24‐hour pain scores; they used 2.5 ± 0.7 compared with 3.5 ± 0.8 (mean and SD) and 1.9 ± 1.4 compared with 2.8 ± 1.4 for single‐port LAVH and multi‐port LAVH, as the primary criterion to calculate a minimum sample size of 45 patients for each group
Participants	n = 102 Inclusion criteria: women, age 30 to 79 years, and an ASA classification of I or II Exclusion criteria: if disease was malignant, if they needed additional adnexal surgery (n = 13) or unwilling to participate (n = 3)
Interventions	Single‐port LAVH versus multi‐port LAVH Single‐port LAVH: A 1.5 cm horizontal intra‐umbilical skin incision, a 1.5 cm to 2 cm rectus fasciotomy to open the peritoneal cavity, insertion small wound extractor. The wrist of surgical glove fixed to outer ring of wound extractor. A 12 mm trocar was inserted through a small hole made in one of the fingertip areas of the glove and advanced into the abdominal cavity. An additional hole for the accessory channel was made in another fingertip of the glove and one 5 mm trocar was inserted Multi‐port LAVH: 4 ports, one 12 mm port inserted umbilically, the other 5 mm ports in lateral abdominal wall and suprapubic; 0 degree rigid 10 mm scope Surgeons: all procedures were performed by a single surgeon, assisted by another surgeon, at a single institute Antibiotics: perioperative antibiotic treatment not reported Postoperative assessment performed by 2 independent investigators
Outcomes	Postoperative pain (at 12, 24 and 48 hours, VAS) Operative time, additional procedures, blood loss, transfusion requirements, postoperative hospital stay
Notes	Taiwan Taipei Veterans General Hospital, Taipei Funding reported, i.e. Taipei Veterans General Hospital, Taipei and Yen‐Tjing‐Ling Medical Foundation, Taiwan
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated numbers
Allocation concealment (selection bias)	Low risk	Numbered, sealed and opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dropouts and loss to follow‐up reported. No loss to follow‐up. 2 discontinued multi‐port LAVH
Selective reporting (reporting bias)	Unclear risk	No primary outcome defined. Insufficient information available
Other bias	Unclear risk	Surgeons reported, but experience unclear. Analysis according to intention‐to‐treat not mentioned

Chung 2015.

Study characteristics
Methods	Single‐centre study Duration: March 2014 and January 2015 Randomisation: all enrolled patients were randomised into one of 2 groups using a computer‐generated random number sequence Allocation concealment: the randomisation codes were placed into sealed, numbered envelopes and assigned to patients upon arrived in the operating room Blinding: yes, after surgery in all patients, 3 skin plasters were applied to the locations of the 3 ports used in multi‐port surgery, even if there was only a single port. Therefore, the patients and the anaesthesiology staff who measured the pain scores were blinded to the type of surgery. Number of women: eligible and randomised = 58 Follow‐up: no long‐term follow‐up period described (48 hours postoperative) Power calculation for sample size: yes
Participants	Mean age: 47.45 in the single‐port access TLH (SPA‐TLH) group and 47.03 in the multi‐port TLH (MPA‐TLH) group Inclusion criteria: hysterectomy for benign uterine pathology Exclusion criteria: suspicion of malignancy, the need for simultaneous interventions such as a prolapse repair, a uterine size greater than 18 weeks of gestation, ongoing peritoneal dialysis, and any disease associated with abdominal pain such as pancreatitis
Interventions	Single‐port access total laparoscopic hysterectomy (SPA‐TLH): performed using a trans‐umbilical single‐port system. No articulating instruments were used. The umbilical incision was 1.5 cm to 2 cm. The uterus was manipulated using a Karl Storz Clermont‐Ferrand uterine manipulator (Karl Storz, Tuttlingen, Germany). All vascular pedicles were secured by bipolar coagulation and sectioned using scissors. All specimens were removed through the vagina by manual morcellation so as to not cause pain at the trocar. Total laparoscopic hysterectomy (TLH): conventional multi (3)‐port access total laparoscopic hysterectomy. Two 5 mm trocars were inserted into the 11 mm camera port at the umbilicus. A 5 mm port was placed in both the left lower and the right lower quadrants of the abdomen. All other procedures were similar to the SPA‐TLH. TLH cuff closure: in both groups cuff closure was performed laparoscopically with 3 figure of 8 sutures using extracorporeal knot tying Surgeons: all surgeries were performed by one of 3 experienced gynaecologic surgeons
Outcomes	Primary outcomes: postoperative pain and use of analgesics Secondary outcomes: surgical outcomes: operation time, blood loss, haemoglobin, transfusion, complications
Notes	Took place in Korea
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	Sealed envelopes opened in the operating room
Blinding (performance bias and detection bias) All outcomes	Low risk	Patients and outcome assessors blinded with use of wound coverings; surgeon not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; only short‐term follow‐up
Selective reporting (reporting bias)	Low risk	No selective reporting obseved
Other bias	Unclear risk	One study participant from each group was excluded and authors performed a per protocol rather than intention‐to‐treat analysis Sources of funding are not reported

Darai 2001.

Study characteristics
Methods	Multicentre study (n = 2), parallel‐group design Duration: January to December 1999 (1 year) Randomisation: pre‐determined computer‐generated randomisation code Allocation concealment: not reported Blinding: no Number of womenrandomised: 80. No dropouts reported. 3 LAVH converted to AH Follow‐up: 6 to 8 weeks after surgery. No loss to follow‐up reported. Power calculation to estimate sample size: yes, 35 women required for each surgery arm (assuming that the incidence of complications in women who had LH(a) was 10% and there was an increase of complication rate to 40%), with an alpha (type I error) of 0.05 and a beta (type II error) of 0.2
Participants	80 women with a mean age of 50 years for the LH(a) group and 49 years for the VH group Inclusion criteria: women scheduled for abdominal hysterectomy for benign disease with traditional contraindications for VH, including uterine size larger than 280 g and one or more of the following: previous pelvic surgery, history of pelvic inflammatory disease (PID), moderate or severe endometriosis, concomitant adnexal masses, indication for adnexectomy and nulliparity without uterine descent Exclusion criteria: anaesthetic contraindications for laparoscopic surgery; suspicious adnexal mass on ultrasound; ovarian blood flow and tumour markers; vaginal narrowed to less than 2 fingers wide; immobile uterus with no descent and no lateral mobilisation
Interventions	VH versus LAVH LAVH: included coagulation and sectioning of the round ligament, utero‐ovarian ligaments with fallopian tubes when ovaries were conserved, and the infundibulopelvic ligaments when ovaries were removed; opening of the bladder flap and bladder dissection, uterosacral ligaments, base of cardinal ligaments and uterine vessels. Vaginal phases included circular incision of the vagina and, when necessary, wedge morcellation, coring or bivalving. Peritoneal closure and closure of the vaginal vault concluded the vaginal phase, at which time the pelvis and abdomen were re‐evaluated through the laparoscope to be sure of haemostasis and for pelvic lavage. LAVH AAGL classification: Type IVB VH arm: according to modified Heaney technique Antibiotics: both groups received prophylactic antibiotic treatment (cefazolin 2 g IV) at the beginning and anticoagulant therapy with low molecular weight heparin the evening before the operation Surgeons: surgeons experienced in laparoscopic and vaginal surgery completed all the operations
Outcomes	Intraoperative and postoperative complications; febrile morbidity; analgesia requirement; postoperative hospital stay; conversion to laparotomy; uterine size and weight
Notes	France 2 hospitals in Paris Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Pre‐determined computer‐generated randomisation code
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts, 3 procedures converted. No loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Insufficient information available. Primary outcome not clearly defined in paper
Other bias	Low risk	No other bias identified

Deimling 2016.

Study characteristics
Methods	Single‐centre study (1 institution) Duration: 23 April to 20 October 2014 Randomisation: participants were randomised by the study statistician, who had no prior access to patient data, to undergo either robot‐assisted or standard laparoscopic hysterectomy; randomisation was performed using a random number generator Allocation concealment: treatment allocations were sealed in opaque envelopes Blinding: participants and study investigators were unmasked to group assignments Number of women: 72 patients randomised to each arm; all patients received the assigned treatment except for one patient who was randomised to the standard laparoscopy group. This patient had severe adhesive disease and did not receive a hysterectomy, but instead underwent laparoscopic lysis of adhesions and the hysterectomy was aborted. Power calculation for sample size: a sample size of 128 patients (64 per arm) would provide 81% power to detect non‐inferiority using a one‐sided test with a significance level of 0.025 Intention‐to ‐treat analysis performed
Participants	72 women in each arm with a mean age of 42.3 (RALH) and 43.2 (LH) respectively Inclusion criteria: all patients scheduled to undergo hysterectomy at the study institution aged 18 to 80 years, able to give informed consent in English Exclusion criteria: patients with medical conditions contraindicating pneumoperitoneum or proper ventilation during anaesthesia, who were pregnant, who had a pelvic organ prolapse allowing for a vaginal approach, or who were anticipated to undergo combined surgical procedures (other than coincidental appendectomy)
Interventions	TLH and robotic‐assisted TLH Conventional: 4 ports Robotic‐assisted: performed with the Da Vinci Surgical System with an umbilical port Standard laparoscopic hysterectomies were performed using three 11 mm trocars, placed through the umbilicus, and the right and left lower quadrants of the abdomen. Robot‐assisted laparoscopic hysterectomies were performed with three 8 mm robotic trocar placed at the same locations as in standard laparoscopic hysterectomy plus one additional accessory trocar in the left upper quadrant. Surgeons: 5 experienced laparoscopists: 75 to 400 LH and at least 20 RH Vaginal cuff closure in both Harmonic scalpel in both No uterine manipulator in both (manipulation done abdominally with laparoscopic single tooth tenaculum if needed)
Outcomes	Primary outcomes: operating time (incision to skin closure) Secondary outcomes: intra‐ and postoperative variables; the intraoperative outcomes recorded included estimated blood loss, additional procedures performed and adverse events. Postoperative outcomes included postoperative pain at 2 hours (measured using a 10‐point numeric analogue scale), length of stay (hours), uterine weight and adverse events.
Notes	Penn State Hershey Medical Center Minimally Invasive Gynecologic Surgery Division, Hershey, PA, USA
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised by the study statistician (ARK), who had no prior access to patient data, to undergo either robot‐assisted or standard laparoscopic hysterectomy; randomisation was performed using a random number generator
Allocation concealment (selection bias)	Low risk	Treatment allocations were sealed in opaque envelopes.
Blinding (performance bias and detection bias) All outcomes	High risk	Participants and study investigators were unmasked to group assignments.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	All patients received the assigned treatment except for one patient who was randomised to the standard laparoscopy group. Intention‐to‐treat analysis performed. Patients were followed to 12 weeks postop; long‐term loss to follow‐up not reported on.
Selective reporting (reporting bias)	Low risk	No evidence of reporting bias identified. Predefined outcomes are reported on.
Other bias	Low risk	Sample size calculation performed a priori Funding sources reported

Eggemann 2018.

Study characteristics
Methods	Prospective, randomised, double‐blind study Duration: between August 2007 and July 2014: 6 years and 11 months Randomisation: randomisation was carried out as computer‐generated block randomisation Allocation concealment: randomisation was stratified by parity and study centre; sealed envelopes containing randomisation numbers were opened in the operating theatre just before the operation started Blinding: yes Number of women: 192 patients Follow‐up: 6 months Power calculation for sample size: sample size calculation was based on the mean consumption of analgesics after LAVH and VH. With an alpha error of 5% and power of 80%, at least 84 patients in each group were needed to detect a difference of consumption of analgesics of less than 5 mg between the groups. Anticipating a 10% dropout rate, at least 92 patients per study arm were to be recruited
Participants	Mean age of patients was 45.5 in the LAVH + peritoneal closure (PC) group, 44.7 in the LAVH without PC group, 47 in the VH + PC group and 46.7 in the VH without PC group Inclusion criteria: patients with indication for hysterectomy with benign gynaecologic disease. The patients were included in the study after clinical and ultrasound examination by two experienced, German board certified gynaecologists who, independently from each other, rendered VH as an appropriate route and method for hysterectomy. Exclusion criteria: incomplete written informed consent, descensus genitalis with indication for sacrocolpopexy or lateral repair, genital malignancy, contraindications for laparoscopy, opioid treatment in the last 12 months longer than 2 weeks, allergy against methamizol and piritramid, adverse psychiatric and neurologic diseases, addiction to drugs and alcohol, polyneuropathy and immunosuppressive therapy
Interventions	LAVH versus VH with or without closure of the peritoneum LAVH: surgery was performed using 3 laparoscopic ports and a uterine manipulator. The round, uteroovarian and ascending uterine artery were transected laparoscopically. Laparoscopy was also used for the creation of the bladder flap. The remainder of the surgery was done vaginally. AAGL LAVH classification: type IIIB VH: after circular colpotomy, the uterosacral ligament and parametrium were clamped cut and sutured followed by the uterine artery and vein. The round ligament and ovarian ligament were then clamped cut and dissected. If needed, morcellation was performed. Prophylactic salpingectomy was done using coagulation and dissection of the mesosalpinx. The cuff was closed with Vicryl suture. Peritoneal closure: performed using absorbable running stitch of 2‐0 Vicryl based on randomisation Prophylactic antibiotics were given to all patients (cephalosporins or clindamycin or patients with an allergy). All patients received low molecular heparin thrombo‐prophylaxis. Surgeons: 12 surgeons were involved in the study, and they were all trained to perform both techniques
Outcomes	Primary outcome: postoperative pain in 4 different groups depending on surgical type of hysterectomy or performance of peritoneal closing Secondary outcomes: postoperative activity and mobility, operating time, blood loss, intra‐ and postoperative complications, additional findings intraoperatively and hospital stay
Notes	Long inclusion period
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated block randomisation
Allocation concealment (selection bias)	Low risk	Sealed envelopes containing randomisation numbers were opened in the operating theatre just before the operation started
Blinding (performance bias and detection bias) All outcomes	Low risk	Patients and outcome assessors blinded. Surgeon not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up, no dropouts. No conversions.
Selective reporting (reporting bias)	Low risk	No reporting bias identified
Other bias	Low risk	No other sources of bias identified. Authors report no funding sources.

Ekanayake 2020.

Study characteristics
Methods	Duration: 1 August 2016 to 31 October 2018 (26 months) Randomisation: block randomisation in multiples of 3, computer‐generated block randomisation numbers (block numbers of 6, 9 to ensure similar numbers of patients in each arm at any point in the study) Allocation concealment: yes (sealed envelopes) Blinding: patients and medical team not blinded Number of women: 147 (exactly 49 per arm) Follow‐up: at 6 months (lost one patient in NDVH and 1 in TLH arms), and at 1 year (lost 2 in TAH, 4 in NDVH and 2 in TLH arms) Power calculation for sample size: 49 per arm (147 total) calculated based on 80% power, type 1 error = 0.05 primary outcome time to recovery (earliest time to resume all or a combination of activities done prior to surgery). A 2nd retrospective power analysis showed sample size of 49 as adequate to detect a 0.5 SD difference in the pelvic organ function domain as assessed by ICIQ‐VS/FLUTS questionnaire at 1 year
Participants	Mean age of participants was 46.5 in the TAH group, 47.6 in the NDVH group and 47.4 in the TLH group Inclusion criteria: patients requiring hysterectomy for non‐malignant uterine causes Exclusion criteria: uterus > 14 weeks, previous pelvic surgery, need for incontinence surgery/pelvic floor surgery, medical illnesses which caution/contraindicate laparoscopic surgery
Interventions	TAH versus NDVH (non‐descent vaginal hysterectomy) versus TLH Details are not provided on surgical methods or surgeons
Outcomes	Outcomes: urinary and sexual function (ICIQ‐FLUTS and ICIQ‐VS) validated questionnaires. Bowel symptoms based on a separate questionnaire. Outcomes reported as median VSS (vaginal symptom score), SSS (sexual symptoms score), urinary voiding symptoms and urinary incontinence symptoms reported at 6 months and 1 year
Notes	Does not report time to return to activities, though this was used to calculate power analysis Does not report bowel symptoms data, though these were collected
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Authors report computer‐generated random assignment
Allocation concealment (selection bias)	Low risk	Assignments were stored in sealed envelopes and opened at the study site. Authors do not provide detail on opacity of envelopes, if sequentially numbered and only opened after being irreversibly assigned to participant.
Blinding (performance bias and detection bias) All outcomes	High risk	Participants and medical teams were not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	No apparent changes to the assigned intervention (no apparent conversion to open or inability to perform assigned route of hysterectomy). Losses to follow‐up fairly evenly distributed between groups and overall low rate of loss to follow‐up overall (5.4% at 1 year). Authors describe performing intention‐to‐treat analysis
Selective reporting (reporting bias)	Low risk	Some inconsistency in pre‐defined vs reported outcomes but because the outcomes they report are negative (no difference) it seems unlikely this lack of reporting influenced the results (i.e. they are not choosing to only report significant findings)
Other bias	High risk	Poorly reported surgical methods, surgeon experience

Ekanayake 2021.

Study characteristics
Methods	Multicentre study, parallel‐group design Duration: August 2016 to October 2018 (2 years and 3 months) Randomisation: computer‐generated block randomisation numbers Allocation concealment: sealed, opaque envelopes Blinding: no Number of women eligible and randomised = 147 Dropouts: there were no dropouts or conversions Follow‐up: women were followed until time to recovery or up to 6 months after surgery. 2 women were lost to follow‐up (1 TLH group and 1 NDVH group). Power calculation for sample size: yes. 49 women required for each surgery group, with a type I error of 0.01 with a power of 80% and a possible loss to follow‐up rate of 20% Analysis by intention‐to‐treat: yes
Participants	147 women with a mean age of 47 years in both the TAH group and NDVH group and of 48 years in the TLH group Inclusion criteria: women with benign uterine disease Exclusion criteria: uterus larger than 14 weeks, previous pelvic surgery, any illness that contraindicated laparoscopy, and any patient requiring surgery for incontinence that or uterovaginal prolapse
Interventions	NDVH and TLH vs. TAH NDVH arm: procedure not reported TLH arm: procedure not reported TAH arm: procedure not reported
Outcomes	Time to recover, operative time, blood loss, pain scores, complications, postoperative hospital stay, direct cost, cost‐effectiveness
Notes	Sri Lanka
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated block randomisation
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts. Multiple participants in each group were lost to follow‐up over an extended (12‐month) follow‐up period. At 12 months the overall loss rate was 5.4%, fairly evenly distributed between the 3 groups.
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes were defined
Other bias	High risk	Surgical procedures not reported in any detail. Surgeon’s experience unclear.

Ellstrom 1998.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: not reported Randomisation: method not stated Allocation concealment not reported Blinding: no Number of women randomised = 40. No dropouts reported Follow‐up: assessment of pain, nausea and vomiting, 8 pm day of surgery, 10 am and 6 pm first day and 10 am second postoperative day. Pulmonary function assessed pre‐operatively and 10 am, first and second day. Time of anaesthesia, surgery, per and postoperative complications and difference in erythrocyte volume fraction (EVF) before and 2 days after surgery. No loss to follow‐up Power calculation for sample size: not reported
Participants	40 women with a mean age of 46 years (LH(a) group) and 48 years (AH group) Inclusion criteria: scheduled for abdominal hysterectomy for benign disorders; maximum width of uterus, measured by transvaginal ultrasound, less than 11 cm. American Society of Anaesthesiologists (ASA) Grade 1 Exclusion criteria: not reported
Interventions	AH versus LH (LAVH). Both groups stratified to total and subtotal hysterectomies LH arm: total hysterectomy (n = 14) and laparoscopic subtotal hysterectomy (n = 6). The laparoscopic part of the total hysterectomy was finished when the uterine artery and parts of the sacrouterine ligaments were transected. The operation was then continued vaginally. Second‐generation cephalosporin and metronidazole were given intravenously during the operation and by oral administration for 2 days after surgery. With the subtotal hysterectomy, morcellation was carried out after transection of the uterine arteries using a mechanical or an electrical morcellator. The cervical canal was desiccated with bipolar cautery. LAVH AAGL classification: IIB AH arm: total hysterectomy (n = 14) and subtotal hysterectomy (n = 6). With the abdominal hysterectomies, standard surgical techniques were used. A lower midline or Pfannenstiel incision was made. The type of incision was left to the individual surgeon and patient to decide Anaesthesia: both groups received standardised anaesthesia; flunitrazepam (1 mg) was given as pre‐medication approximately 2 hours before surgery. Anaesthesia was induced with propofol (1.5 to 2.5 mg per kg body weight). Morphine (100 uG per kg body weight) was given for perioperative analgesia. Neuromuscular block was achieved with vecuronium (0.1 mg per kg body weight). Suxamethonium (1.0 mg per kg body weight) was administrated for optimal intubation. Anaesthesia was maintained with isoflurane in oxygen/air. Morphine was postoperatively self‐administered by the patients by programmable infusion pump containing morphine 1.0 mg/mL. Additional analgesic medication was restricted to paracetamol. Patients with nausea were given 10 mg metoclopramide. Surgeon experience: not reported
Outcomes	Primary: postoperative pain, pulmonary function Secondary: time of anaesthesia, time of surgery, per and postoperative complications, difference in erythrocyte volume fraction (EVF)
Notes	Sweden University Hospital of Sahlgrenska Funding: Goteborg Medical Society Fund, Swedish Medical Research Council
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Low risk	Primary outcome clearly defined
Other bias	High risk	Analysis according to intention‐to‐treat unclear; no exclusion criteria reported. No sample size calculation performed. Surgeon's experience not reported

Falcone 1999.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: September 1995 to February 1997 (1 year, 6 months) Randomisation: assigned according to a computer‐generated randomisation schedule with random block sizes Allocation concealment: all patients were told of their assignment before surgery Blinding: no Number of women randomised = 48, number analysed = 44 Dropout: 4 withdrew before surgery (3 AH group and 1 LH group) Follow‐up: daily diary for 6 weeks, recording symptoms, lifestyle impact, life events, medication. In each arm, 1 patient refused to keep a diary Power calculation for sample size: yes, 22 patients per group were necessary to detect a difference of 30 minutes or more in surgical time between the 2 groups with 90% power and a significance level of 0.05 Analysis by intention‐to‐treat: yes
Participants	44 women with a mean age of 42.8 years (LH group) and 43.8 years (AH group) Inclusion criteria: scheduled for abdominal hysterectomy for benign disease Exclusion criteria: pelvic mass size greater than 2 cm below the umbilicus; concomitant incontinence or pelvic reconstructive procedures required
Interventions	AH versus LH LH arm: 3 x 10 mm trocar sites ‐ 1 umbilical and 1 in each lower quadrant lateral to inferior epigastric artery 6 cm to 8 cm above pubic rami. Uterine arteries occluded laparoscopically with electrocautery. Cardinal ligaments cut laparoscopically. If the uterus had minimal descent, uterosacral ligaments were also cut laparoscopically. Vagina incised either laparoscopically or vaginally, depending on the ease that this could be achieved. Either anterior or posterior fornix, depending on access. Surgery then completed vaginally. Vaginal cuff closed vaginally AAGL LAVH classification: II‐IV Surgeons: performed by senior author with assistance from pelvic surgery fellow or resident Postoperative pain relief was given to patients intravenously AH arm: procedure not reported
Outcomes	Operative time; blood loss; length of hospital stay; uterine weight; intraoperative complications; postoperative pain; return to work/normal activities and hospital costs per patient
Notes	USA Cleveland Clinic Foundation, Ohio Funding by Ethicon Endosurgery and the Minimally Invasive Center of the Cleveland Clinic Foundation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation schedule with random block sizes
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	4 patients withdrew before surgery and data were included where possible. In each arm 1 patient was lost to follow‐up
Selective reporting (reporting bias)	Low risk	No reporting bias identified
Other bias	Unclear risk	Funding from pharmaceutical or surgical instrumentation company. Surgeon's experience unclear

Ferrari 2000.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: 24 months Randomisation: computer‐generated randomisation numbers Allocation concealment: sealed, opaque envelopes Blinding: no Number of women randomised: 62. No dropouts reported. With 3 women in the LAVH group, the procedure was converted to an AH. In all cases the decision was made during the laparoscopic part of the procedure. Follow‐up: women were followed up until discharge from hospital. Postoperatively, temperature and analgesic requirement were recorded daily. No loss to follow‐up Power calculation for sample size: no
Participants	62 women aged from 43 to 50 years Inclusion criteria: symptomatic uterine fibroids Exclusion criteria: history of severe pelvic disease; lack of uterine accessibility and mobility or a sonographically estimated uterine volume > 1500 mL (abdominal hysterectomy). Women without a history of severe pelvic disease, with an accessible and mobile uterus and a sonographically estimated uterine volume < 500 mL, underwent a vaginal hysterectomy
Interventions	AH versus LH (LAVH) LAVH arm: visualisation of the pelvis and upper abdomen, the treatment of adhesions or endometriosis when present, and the completion of the upper part of the hysterectomy. Round ligaments, tubes and utero‐ovarian ligaments were desiccated and transected when the adnexa were to be preserved, while the round and infundibulopelvic ligaments were desiccated and transected when the adnexa were to be removed. The broad ligaments were dissected to their lower margin. When the bladder was stretched over the anterior aspect of the uterus due to previous surgery, the bladder flap was developed laparoscopically. The vaginal part of the hysterectomy included colpoceliotomy and bilateral ligation and transection of utero‐sacral ligaments, uterine vessels and cardinal ligaments; cervical amputation, corporal hemisection, myomectomy and uterine morcellation were performed when necessary. AAGL LAVH classification: IB AH arm: performed according to a standard technique Surgeon experience: not reported
Outcomes	Operating time; blood loss; complications; febrile morbidity; analgesic administration and hospital stay
Notes	Italy San Paolo Biomedical Sciences Institute, University of Milan Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation numbers
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Primary outcome not predefined
Other bias	Unclear risk	Surgeon's experience unclear. Power calculation for sample size not performed

Garry 2004.

Study characteristics
Methods	Multicentre study (n = 30), parallel‐group design Duration: November 1996 to September 2000 (4 years) Randomisation: 2:1 unbalanced randomisation method. Allocation to abdominal or vaginal trial by surgeon. Randomisation to conventional or laparoscopic approach was performed with a computer‐generated program. Allocation concealment: not described Blinding: no Number of women randomised: 1380 Abdominal trial: 876 (AH: 292, aLH: 584) Vaginal trial: 504 (VH: 168, vLH: 336) Number of patients that withdrew/dropped out pre‐operatively: AH: 6, aLH: 11, VH: 5, vLH: 12 Follow‐up: 6 weeks, 4 months and 1 year. In the abdominal trial: AH arm ‐ 6 weeks n = 17, 4 months n = 104, 1 year n = 104; LH arm ‐ 6 weeks n = 29, 4 months n = 166, 1 year n = 166. In the vaginal trial: VH arm ‐ 6 weeks n = 10, 4 months n = 55, 1 year n = 55; LH arm ‐ 6 weeks n = 27, 4 months n = 110, 1 year n = 118 Power calculation to estimate sample size: yes. The sample size for the abdominal trial was calculated on the basis of 9% of AH having major complications. In order to detect a reduction in complication rate of 50%, a sample size of 450 in each arm was required using 80% power and a 2‐sided type 1 error rate of 5% Results were confirmed using a per‐protocol analysis
Participants	1380 women with a mean age of 41 years Inclusion criteria: women who needed hysterectomy for non‐malignant conditions Exclusion criteria: confirmed or suspected malignant disease of any part of the genital tract; 2nd or 3rd degree uterine prolapse; a uterine mass greater than the size of a 12‐week pregnancy; any associated medical illness precluding laparoscopic surgery; a requirement for bladder or other pelvic support surgery and patient refusal of consent for the trial
Interventions	4 arms: VH, LH in the vaginal trial (vLH); AH and LH in the abdominal trial (aLH) Surgical procedures: distribution and detailed surgical methods were not reported. Authors describe LH arms including a combination of LAVH, TLH and supracervical hysterectomies. Surgeons recruited had to have performed at least 25 of each type of procedure, however cases could be used for teaching if the main assistant was the designated surgeon. Surgeons of all grades and experience participated.
Outcomes	Primary outcomes: major complications (major haemorrhage, bowel injury, ureteric injury, bladder injury, pulmonary embolus, anaesthesia problems, unintended laparotomy, wound dehiscence, haematoma) Secondary outcomes: minor complications (major haemorrhage, anaesthesia problems, pyrexia, infection, haematoma, DVT); blood loss; pain; analgesia requirement; sexual activity; body image; health status; length of surgery; length of hospital stay
Notes	UK (28 centres) and South Africa (2 centres) Funding: National Health Service Research and Development Health Technology Assessment Programme, UK
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised with use of a computer‐generated program
Allocation concealment (selection bias)	Low risk	Telephone enquiry
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	17 patients in each trial dropped out before surgery and sensitivity analysis was performed. In the AH arm and LH arms particularly loss to follow‐up was high (> 15%) Quality of life outcome at baseline reported in 76% of women
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes well‐defined
Other bias	Unclear risk	Surgical procedures not reported. Surgeons of all grades and experience participated

Ghezzi 2010.

Study characteristics
Methods	Single‐centre Duration: February 2009 to September 2009 (7 months) Randomisation: computer‐generated list Allocation concealment: treatment allocation was concealed until the day of surgery Blinding: no Number of women: 123 women eligible, of which 82 randomised: 41 randomised to LH and 41 randomised to VH. No dropout Follow‐up: no loss to follow‐up Power calculation to estimate sample size: yes, based on mean VAS pain score after VH reported by Candiani et al (2011). With an alpha error of 5% and a power of 95%, at least 40 patients in each group needed to detect a 50% decrease in the mean postoperative pain on day 0 in patients with LH Intention‐to‐treat analysis: not reported
Participants	82 women with a mean age of 48 years in both groups Inclusion criteria: indication for hysterectomy for a supposed benign gynaecological condition Exclusion criteria: uterine volume > 14 weeks of gestation, suspicion of malignancy, concomitant presence of large adnexal masses (diameter > 4 cm) and pelvic organ prolapse > stage 1 according to the Pelvic Organ Prolapse Quantification System (POP‐Q). Chronic pelvic pain and endometriosis or PID were excluded.
Interventions	TLH versus VH TLH: intrauterine manipulator inserted. 5 mm scope umbilical site. 3 5 mm ancillary trocars inserted, 1 suprapubically and 2 laterally. Coagulation and dissection of round ligaments and infundibulopelvic ligaments. Broad ligament opened to uterovesical fold, caudal reflection of bladder. Uterine arteries, cardinal ligaments and uterosacral ligaments coagulated and transected. Colpotomy with monopolar hook. Uterus extracted vaginally. TLH cuff closure: vaginal cuff closure was performed in a single layer with No. 0 synthetic reabsorbable suture. Unclear if this was done vaginally or laparoscopically. VH: performed according to a standardised technique Surgeons: surgical team and their experience were not reported Antibiotic and antithrombotic prophylaxis administered postoperatively
Outcomes	Primary outcome: postoperative pain (VAS at 1, 3, 8 and 24 hours after procedure) Secondary outcome: operative time
Notes	Varese, Italy Del Ponte Hospital, University of Insubria Funding: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation with use of a computer‐generated list
Allocation concealment (selection bias)	Unclear risk	Concealed until day of surgery. Method of concealment not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dropout and loss to follow‐up reported. Low numbers
Selective reporting (reporting bias)	Unclear risk	Primary outcome not clearly defined in methods of study
Other bias	Low risk	Surgical experience reported

Harkki‐Siren 2000.

Study characteristics
Methods	Single‐centre study, parallel‐group design with no blinding Duration: March to September 1997 (6 months) Randomisation: patients were randomly allocated Allocation concealment: sequentially numbered, opaque and sealed envelopes Blinding: no Number of women randomised: 50. No dropouts reported. Tissue trauma analysis for 18 uncomplicated hysterectomies in both groups were included Follow‐up: first follow‐up visit was scheduled 4 weeks after the operation and then followed up until complete recovery. No loss to follow‐up Power calculation for sample size: yes, 21 women in each group would be needed for 90% study power and for differentiation of 10 mg/L (standard deviation) between the means of C‐reactive protein (CRP) concentration when type I error is 5%. For 80% study power, 15 women in each group needed.
Participants	50 women with a mean age of 47 years (LH(a) group) and 48 years (AH group) Inclusion criteria: scheduled for AH for benign reasons Exclusion criteria: major medical diseases; BMI above 32 kg/m2; size of uterus larger than of 14 weeks of pregnancy or uterine width greater than 10 cm by transvaginal ultrasonography; severe adhesions or endometriosis; prolapse and any other contraindications for laparoscopy
Interventions	AH versus LH LH arm: a 5 mm trocar was inserted suprapubically. Pelvis was inspected and ureters located. The uterosacral ligaments were coagulated with bipolar electrocoagulation and cut with unipolar scissors, as were the infundibulopelvic vessels and ligaments (if adnexa were to be removed) or the round ligaments, fallopian tubes and utero‐ovarian ligaments (adnexa not removed). The vesical peritoneum was opened with scissors and the bladder pulled down. Uterine vessels were prepared free and divided. The anterior fornix of the vagina was opened laparoscopically with monopolar scissors, the uterus was removed vaginally and the vagina was closed with resorbable suture. AAGL classification: description sounds most like IVE or TLH Vaginal cuff closure: technique not described AH arm: operated on in a standard manner through a lower midline or Pfannenstiel incision. Diathermy was used only for haemostasis and peritoneal closure was performed All women received 500 mg metronidazole intravenously at the beginning of anaesthesia and operations were performed under GA with endotracheal intubation in both groups. The bladder was drained with a Foley catheter in all women. A drain was left from the perineal cavity in both groups Surgeon experience: not reported
Outcomes	Operating time; anaesthetic time; blood loss; haemoglobin change; hospital stay; sick leave and complications
Notes	Finland Jorvi Hospital, Espoo Funding: The Clinical Research Institution of Helsinki University Central Hospital and Jorvi Hospital, The Finnish Medical Foundation and The Research Foundation of Orion Corporation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Patients were randomly allocated. Method not clearly described
Allocation concealment (selection bias)	Low risk	Sequentially numbered and sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Insufficient information available
Other bias	Unclear risk	Tissue trauma reported in uncomplicated surgeries only Funding from pharmaceutical or surgical instrumentation company

Hwang 2002.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: June 1999 to May 2001 (2 years) Randomisation: sealed envelopes containing computer‐generated block randomisation numbers, block size of 10 Blinding: no Number of womenrandomised: 90. No dropouts reported. Follow‐up: 6 weeks after surgery Power calculation to estimate sample size: yes. Power of analysis was 80% at alpha = 0.05. Result of power calculation not reported.
Participants	90 women with a mean age of 45.1 years Inclusion criteria: scheduled for hysterectomy for uterine fibroids; myoma diameter larger than 8 cm and second myoma less than 5 cm or 2 myomata, both at least 6 cm in diameter but less than 8 cm (maximum number of fibroids was 3) Exclusion criteria: indications of adenomyosis; uterine prolapse; chronic pelvic pain; dysfunctional uterine bleeding; cervical dysplasia; pelvic inflammatory disease
Interventions	AH versus VH versus LH (LH) AH arm: abdomen opened by vertical midline or Pfannenstiel skin incision. Uterus removed by extrafascial technique and vaginal cuff closed with continuous interrupted suture followed by re‐peritonealisation VH arm: patients in Trendelenburg tilt position and given vasopressin injection. Anterior circumferential incision of the cervix and posterior V‐shape incision. Anterior peritoneal cavity opened and cul‐de‐sac of Douglas entered. After uterine artery ligation, volume reducing techniques were performed vaginally. Peritoneum closed and uterosacral ligaments and vaginal vault sutured. LH arm: 10 mm trocar inserted into umbilical position, one 5 mm trocar in each lower quadrant and another inserted suprapubically. Uterosacral ligament incision and round and broad ligaments were excised. Anterior colpotomy was performed after ligation of the bilateral uterine artery. The rest of the hysterectomy was completed vaginally. The uterus was removed vaginally by volume reducing techniques and the vaginal cuff was closed. AAGL LAVH classification: IIB All operations performed under general anaesthesia by second author, with the assistance of the other authors. Standardised postoperative protocol of 2 doses of IV meperidine 50 mg every 4 hours for pain control followed by acetaminophen 325 mg every 6 hours Prophylactic antibiotics (cephalosporin 1.0 g every 8 hours (3 doses/day) combined with aminoglycoside 80 mg every 12 hours (2 doses/day), were administered to all for 1 day after surgery Surgeons' experience: 1 surgeon performed all procedures and had much experience
Outcomes	Operating time; hospital stay; intraoperative blood loss; complications; postoperative tenderness score; return to work; antibiotics used
Notes	Taiwan Shin Kong Wu Ho‐Su Memorial Medical Centre, Taipei Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated block randomisation numbers
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts. No loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Insufficient information
Other bias	Unclear risk	Uterine weight in AH group was significantly higher than in VH and LAVH group

Jung 2011.

Study characteristics
Methods	Single‐centre Duration: October 2009 to March 2010 (5 months) Randomisation: based on computer‐generated random sampling numbers Allocation concealment: not described Blinding: no Number of womenrandomised: 68; 34 in TLH arm analysed, 30 in SP‐LH arm analysed: 4 converted procedures excluded from analysis Follow‐up: no loss to follow‐up Power calculation for sample size: yes, a difference of 0.8 in the VAS score was considered clinically relevant. The number of cases needed per group was 34 Intention‐to‐treat analysis not applied
Participants	Mean age was 48 years Inclusion criteria: age ≥ 20 years, no evidence of gynaecologic malignancy, normal cervical cytology or histology, appropriate medical status for laparoscopic surgery (ASA 1 or 2), adequate uterus size for vaginal removal (≤ 12 weeks) Exclusion criteria: uterine size larger than 12 weeks, history of pelvic radiation therapy, suspicion of gynaecologic cancer, more than 3 prior laparotomies, treated for gastrointestinal or gynaecologic malignancy
Interventions	SP‐TLH versus 4‐port/conventional TLH Conventional TLH: 4 x 5 mm trocars were placed. A 5 mm port for the laparoscope inserted through the umbilicus. 2 x 5 mm ports were placed in the left lower quadrant of the abdomen and one in the right lower quadrant SP‐TLH: a 1.2 cm vertical intra‐umbilical skin incision was made and a 1.5 cm rectus fasciotomy was performed for entrance to the peritoneal cavity. A single 3‐channel port was used. After introduction in both arms the procedure was performed similarly. Utero‐ovarian ligaments and round ligaments and broad ligaments were sequentially ligated and dissected. The vesico‐uterine peritoneal fold was opened and the bladder mobilised. The uterine vessels were sealed and dissected. The uterus was removed vaginally; some had to be morcellated. Cuff closure: the vaginal vault was sutured laparoscopically or transvaginally, depending on the surgeon's decision Surgeons' experience: all procedures performed by 3 skilled surgeons. Surgical experience: at least 100 LH and 30 SP‐LH
Outcomes	Primary: postoperative pain (VAS) and need of analgesics Secondary: operative time, intra‐ and postoperative complications, postoperative hospital stay, haemoglobin
Notes	Korea Gangnam Medical Center, Seoul Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation: based on computer‐generated random sampling numbers
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not described
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No loss to follow‐up, 4 converted procedures in SP arm excluded from analysis
Selective reporting (reporting bias)	Unclear risk	Converted procedures not analysed; primary and secondary outcomes predefined
Other bias	Low risk	No other bias identified

Kim 2015.

Study characteristics
Methods	Multicentre study (8 Korean university hospitals) Duration: December 2011 to April 2013 (17 months) Randomisation: treatment allocation was determined by a computer‐generated randomisation schedule with random block sizes (2 to 6) and was stratified by institution Allocation concealment: treatment assignments were placed in sequentially numbered, opaque, sealed envelopes that had been prepared earlier by a third party. Envelopes were opened on the morning of surgery. Blinding: no, randomisation could not be blinded for either patients or surgeons because the same surgeons conducted the postoperative evaluations Number of women: 251 Follow‐up: 2 months Power calculation for sample size: no
Participants	Median age of women in both groups was 47 years old Inclusion criteria: elective patients between ages 20 and 60 years with symptomatic myomas or adenomyosis such as dysmenorrhoea, pelvic pain or discomfort, urinary symptoms, and a palpable mass of increasing size or menorrhagia for a duration of at least 2 months Exclusion criteria: uterine size 18 gestational weeks by pelvic examination and those at risk of surgical complications due to an underlying medical disease such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis or uncontrolled diabetes
Interventions	Single‐port versus multi‐port LH The 14 participating surgeons did not standardise their LH technique but followed the American Association of Gynecologic Laparoscopists (AAGL) classification system based on their preferred approach. Postoperative care was also not standardised and was prescribed according to each institution’s policies. Surgeon experience: 14 surgeons with experience in more than 100 multi‐port LH procedures each, and considered experts, participated in this study. Only 5 surgeons among these 14 had experience in greater than 50 single‐port LH at the time of the study. Assisting surgeons were obstetrics and gynaecology residents.
Outcomes	Primary outcomes: conversion and/or complication proportion of the planned procedure. The definition of conversion was either the placement of any additional port(s) to what was originally planned or conversion to open hysterectomy. Secondary outcomes: postoperative pain and cosmetic scar satisfaction
Notes	8 Korean teaching hospitals
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Treatment allocation was determined by a computer‐generated randomisation schedule with random block size
Allocation concealment (selection bias)	Low risk	Treatment assignments were placed in sequentially numbered, opaque, sealed envelopes that had been prepared earlier by a third party
Blinding (performance bias and detection bias) All outcomes	High risk	Patients and surgeons were not blinded to treatment allocation. Unclear/not reported if outcome assessors were blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Three patients in the single‐port group and 2 in the multi‐port group withdrew from the study before surgery but after randomisation. Follow‐up: SILS group: n = 3 lost to follow‐up, multi‐port group: n = 5 lost to follow‐up.
Selective reporting (reporting bias)	Low risk	No reporting bias identified. They had pre‐specified primary and secondary outcomes.
Other bias	Unclear risk	There were 14 participating surgeons who had extensive experience in traditional laparoscopy and less experience in single‐port laparoscopy (only 5 surgeons among these 14 had experience in more than 50 single‐port LH at the time of the study) They did not utilise a standardised LH technique. Postoperative care was also not standardised and was prescribed according to each institution’s policies. They do report a power calculation

Kluivers 2007.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: August 2002 to January 2005 (2 years, 6 months) Randomisation: randomly allocated Allocation concealment: sealed, opaque envelopes Blinding: no Number of women eligible = 88, randomised = 59 Dropouts: in the LH group, 1 woman refused the allocated procedure and an AH was performed. There were 2 intraoperative conversions to AH. There were 2 patients with re interventions (laparotomy) in the AH group Follow‐up: women were followed up until 3 months after surgery. At 12 weeks the follow‐up was complete in 81% of the LH group and 94% of the AH group Power calculation for sample size: yes, 28 patients per group were necessary to detect a difference between the 2 groups of 15 units or more on each of the 8 RAND‐36 subscales with standard deviation 20 units and 80% power with a significance level of 0.05 Analysis was by intention‐to‐treat
Participants	59 women with a mean age of 46 years in both groups Inclusion criteria: women with benign disease in whom VH was not possible and LH was feasible Exclusion criteria: suspicion of malignancy, a previous lower midline incision, the need for simultaneous procedures like prolapse repair, inability to speak Dutch
Interventions	TAH versus TLH AH: was performed according to the extrafascial technique (clamps and suture ligation) TLH: intentional TLH procedures, using the Storz uterine manipulator type Clemont Ferrand, and a 4‐port technique with bipolar coagulation and scissors. Opening the bladder flap and colpotomy (with the use of monopolar coagulation) were performed laparoscopically. Cuff closure: laparoscopic extracorporeal suturing of the vagina Antibiotic treatment: both groups received prophylactic antibiotic treatment (amoxicillin clavulanate 2.2 g IV) and anticoagulant therapy Anaesthesia: general anaesthesia for both AH and LH Surgeons: 10 different surgeons carried out AH, of whom 3 surgeons also carried out LH; (supervising) surgeons had performed at least 100 procedures
Outcomes	Primary: quality of life (questionnaire RAND‐36) Secondary: operative time; blood loss; operative complications (injury to adjacent organs, haemorrhage, anaesthesia problems); conversions to AH, LAVH, LH(a) or subtotal hysterectomy; haemoglobin decrease; postoperative complications; hospital stay; use of opioids and antiemetics
Notes	The Netherlands Maxima Medical Centre, Veldhoven No funding
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	States patients were randomly allocated, but no description of how
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes shuffled and sequentially numbered
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding
Incomplete outcome data (attrition bias) All outcomes	High risk	1 refused assigned procedure and was analysed in assigned treatment group. Loss to follow‐up was almost 20% in LH group; in AH group 6%
Selective reporting (reporting bias)	Low risk	Primary outcomes predefined and reported accordingly
Other bias	Unclear risk	Different group of surgeons for different procedures. More residents as first surgeon in AH

Kongwattanakul 2012.

Study characteristics
Methods	Single‐centre. Stratified, open, randomised, controlled, parallel‐group trial Duration: April 2010 to March 2011 (1 year) Randomisation: computer‐generated list. Stratified random sampling. Group 1: uterus ≤ 12 weeks of gestation (n = 32); Group 2: uterus > 12 to 16 weeks of gestation (n = 11); Group 3: history of abdominal surgery (n = 7) Allocation concealment: sealed, opaque, numbered envelopes Blinding: researcher blinded; patients not blinded Number of women: after randomisation: LAVH 25 (group 1 = 16; group 2 = 6; group 3 = 3); AH 25 (group 1 = 16; group 2 = 5; group 3 = 4) Follow‐up: until discharge from the hospital. No loss to follow‐up. Power calculation for sample size: yes, it was calculated from the population mean from a sample size determination as per WHO Health Studies. A power calculation verified that no more than 24 patients were needed in each group. Analysis by intention‐to‐treat: not reported
Participants	50 women Inclusion criteria: indication for hysterectomy because of benign disease. Uterus ≤ 16 weeks. Exclusion criteria: cardiopulmonary disease, cardiac arrhythmias, history of ischaemic heart disease, other medical risks
Interventions	LAVH versus AH Surgical techniques not reported AAGL LAVH classification: unknown Surgeons: 2 surgeons who performed both procedures at least 30 times Preoperatively antibiotic prophylaxis cefotaxime 1 g
Outcomes	Intraoperative blood loss, duration of operation, intraoperative and early postoperative complications, conversion rate, pain, duration of hospital stay
Notes	Thailand Srinagarind Hospital, Khon Kaen Funding: grant support by the Faculty of Medicine of Khon Kaen University
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation by means of a computer‐generated list of random numbers
Allocation concealment (selection bias)	Low risk	Sealed, opaque, numbered envelopes
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Blinding of researcher; patients not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up reported, conversion rate reported
Selective reporting (reporting bias)	Unclear risk	Insufficient information available
Other bias	Unclear risk	Not reported if 3 groups are comparable on basic characteristics; power calculation unclear

Kunz 1996.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: November 1993 to February 1995 (1 year, 4 months) Randomisation: method not reported Allocation concealment: not reported Blinding: no Number of womenrandomised: 70, number analysed = 70. No dropouts. Follow‐up: until discharge from the hospital. No loss to follow‐up. No power calculation for sample size was reported
Participants	70 women with a mean age of 43 (LAVH group) and 48 years (AH group) Inclusion criteria: scheduled for hysterectomy for non‐malignant diseases Exclusion criteria: not reported
Interventions	AH versus LAVH LAVH arm: a curette was inserted into the uterus and the laparoscopic video camera was introduced. 2 x 5 mm trocars were inserted. Division of the adnexopexy from the uterus or the infundibulopelvic ligaments and round ligaments was accomplished with tissue tension, bipolar coagulation and the use of hook scissors. Transverse incision on the anterior fold of the broad ligaments bilaterally and transection of the visceral peritoneum at the bladder resection. Separation of the posterior fold of the broad ligaments, uterine arteries are skeletonised and demonstrated close to the uterus (2 cm). The hysterectomy was continued vaginally. The cervix was circumcised and the vaginal skin is reflected. Reflection of the bladder and the anterior peritoneum is demonstrated. The pouch of Douglas is entered and the sacrouterine ligaments are clamped and ligated. Uterine arteries are clamped and ligated bilaterally and the uterus extracted vaginally. The sacrouterine ligaments are fixed together and the vagina is closed in interrupted sutures. AAGL LAVH classification: IIA AH arm: the abdominal hysterectomies followed a common technique (Ober and Meinrenken 1964) Antibiotics: both groups received perioperative antibiotic prophylaxis with 2 g of cephalosporin (Ceftriaxon), 15 minutes prior to the operation Both groups had a pre and postoperative vaginal ultrasound scan. Pre and postoperative blood tests and measured CRP postoperatively (day 1 and 3) Postoperative analgesia was piritramid (22 mg ampoule), pentazocin (30 mg ampoule) and tramadol hydrochloride (100 mg orally)
Outcomes	Operating time, pain relief, size of uterus, haemoglobin change, stay in hospital and complications
Notes	Germany Hospital in Stuttgart Funding not reported Paper in German language. Translation was commissioned
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Primary outcome not defined
Other bias	High risk	No exclusion criteria; no power calculation for sample size. Surgeons' experience unclear

Langebrekke 1996.

Study characteristics
Methods	Multicentre study (n = 2), parallel‐group design Duration: not reported Randomisation: a table of random digits, numbered 1 to 100 Allocation concealment: sealed envelopes Blinding: no Number of womenrandomised: 100, number analysed = 100. No dropouts or conversions. Follow‐up: until women returned to work/normal activities. No loss to follow‐up. No power calculation for sample size was reported
Participants	100 women. The age of the women was not reported. Inclusion criteria: women with indications for elective hysterectomy Exclusion criteria: proven or suspected malignancies in the pelvic area, suspected intra‐abdominal adhesions; uterus enlarged beyond the size of a 12‐week size pregnancy; serious cardiopulmonary disease; previous colporrhapy
Interventions	AH versus TLH TLH arm: a 10 mm laparoscope was inserted through the umbilicus and a general inspection of the entire pelvic cavity was performed. 2 x 5 mm trocars were introduced into the iliac fossae. A 12 mm trocar was placed in the midline 4 cm below the umbilicus in cases where the automatic stapler endo‐GIA was used. Bipolar diathermy or GIA were used to divide the ligaments. With unipolar scissors, the vesicouterine perineal fold was cut and the bladder mobilised. The uterine arteries were coagulated with bipolar diathermy. The vagina was opened laparoscopically with unipolar scissors and the uterus removed vaginally. Vaginal cuff closure: the vagina was closed with resorbable sutures from below, the sutures including the cardinal ligaments Surgeons: all operations performed exclusively by 2 of the authors AH arm: according to standard techniques. Abdomen was entered via a Pfannenstiel incision. The entire abdominal cavity was palpated and the pelvis inspected. The uterine ligaments were clamped and ligated. The bladder peritoneum was opened and the bladder was mobilised away from the cervix and upper anterior vaginal wall. Uterine vessels were clamped, cut and ligated. The vagina was closed with resorbable sutures. Performed by any skilled gynaecologist in the department Antibiotics: cephalosporin (2 g IV) and low molecular heparin (injected subcutaneously) was given to both groups postoperatively Surgeons: different group of surgeons for different procedures
Outcomes	Operation time; hospital stay; time elapsed before resuming work; postoperative pain; complications and blood loss
Notes	Norway (2 centres) Aker University Hospital, Oslo, and Akershus central Hospital, Oslo Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Table of random digits
Allocation concealment (selection bias)	Low risk	Sealed envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Primary outcome not defined
Other bias	Unclear risk	Different group of surgeons for different procedures

Long 2002.

Study characteristics
Methods	Single‐centre study, parallel‐group design with no blinding Duration: November 1999 to December 2000 (1 year, 1 month) Randomisation: randomly assigned to treatment groups. Method not stated. Allocation concealment: not reported Number of women randomised: 167. Number of dropouts = 13. Number of women analysed = 101 (women excluded if hysterectomy performed for reasons other than uterine fibroids of adenomyosis). Follow‐up: until discharged from hospital. No loss to follow‐up reported. Power calculation for sample size: no Intention‐to‐treat analysis: no
Participants	101 women with a mean age of 45.9 (LAVH group) and 45.5 (TLH group) Inclusion criteria: indications of uterine fibroids of adenomyosis and contraindications for VH ‐ uterine weight > 280 g, previous pelvic surgery, history of PID, need for adnexectomy, lack of uterine descent and limited vaginal access Criteria for choosing laparoscopic hysterectomy were based on the uterine volume, less than that of a 16‐week pregnancy (700 g) Exclusion criteria: suitable for a vaginal hysterectomy and the uterine volume was greater than a 16‐week pregnancy
Interventions	LAVH versus TLH (a comparison of 2 LH techniques) LAVH arm: if the ovaries were to be conserved, the fallopian tubes, round and utero‐ovarian ligament was resected with bipolar forceps and scissors. For adnexectomy, mesosalpinx, round and infundibulopelvic ligament were resected. Laparoscopic dissection of the bladder flap, resection of the broad ligaments, anterior and posterior colpotomies were performed. Proceeded vaginally ‐ clamping, transecting and suture ligating of uterine vessels, cardinal and uterosacral ligaments. Closure of peritoneum and vaginal vault anchored to the cardinal‐uterosacral ligament complex after removing uterus AAGL LAVH classification: ID TLH arm: same manner as the LAVH procedure above the uterine artery level. After dissection of the bladder flap and resection of the broad ligament, the uterine artery was coagulated by bipolar electrocoagulator and separated from the uterine sidewall by scissors. Bilateral desiccation and transection of the cardinal‐uterosacral ligament complex. Circular colpotomy was performed close to the cervix and uterus was removed through the vagina Vaginal cuff closure: done laparoscopically with three endosutures All operations performed under GA Surgeons: by the same gynaecologist for each procedure (LAVH by one surgeon and TLH by another) Postoperative analgesia included lysine aspirin, which was administered intravenously Antibiotic prophylaxis IV cefazolin 1 g administered pre and postoperatively
Outcomes	Operation time, blood loss, hospital stay, cost, complications and sexual symptoms
Notes	Taiwan Kaohsiung Municipal Hsiao Kang Hospital Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	13 dropouts (excluded from analysis after randomisation because of conversions to AH (n = 3), incomplete records (n = 7) or combined surgical procedures (n = 3)). No further loss to follow‐up reported
Selective reporting (reporting bias)	Unclear risk	Primary outcome not defined
Other bias	High risk	Analysis not according to intention‐to‐treat. Different surgeons for different procedures Women were randomised to treatment groups before a large number (i.e. 66) of the women were excluded. Therefore, the women in each treatment group may not have been a true representation of the original randomised groups

Lumsden 2000.

Study characteristics
Methods	Multicentre (n = 3) study, parallel‐group design Duration: 2 years Randomisation: performed by the research nurse using a computer‐generated schedule Allocation concealment: by third party (research nurse) Number of womenrandomised: 200, number analysed = 190. Dropouts: 7 did not attend for operation and the case records were not available for a further 3 women Follow‐up: women asked to keep a diary of recovery 'milestones' and reviewed by the research nurse 4 weeks after surgery. EuroQol Health Questionnaire completed at 1, 6 and 12 months after surgery. The response rate for the patient questionnaire was 87% and that for EuroQol was 78%, 64% and 47% at 1, 6 and 12 months, respectively. Power calculation for sample size: yes; 120 patients per arm allowed an 80% chance of detecting a 15% difference in complication rates at a 5% level using a 2‐sided test Analysis was stated as by intention‐to‐treat (8 women did not have LAVH as randomised but were analysed in the LAVH group)
Participants	190 women with a mean age of 42.7 years (AH group) and 41.1 (LH group) Inclusion criteria: scheduled for AH for benign gynaecological disease and they were not suitable for VH because of a uterine size in excess of 14 weeks or a requirement for oophorectomy Exclusion criteria: suitable for VH
Interventions	AH versus LH. Operation procedures not reported Surgeons: performed by 5 consultant gynaecologists who have undertaken a minimum of 50 LH procedures
Outcomes	Length of operation; length of hospital stay; admission to ITU; readmissions; women requiring additional surgery; blood transfusions; complications (major and minor); patient‐reported outcomes; costs and change in health status
Notes	Scotland 3 hospitals in Glasgow Funding: Scottish Home and Health Department, Scotland
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	Low risk	By third party (research nurse)
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	10 dropouts were not analysed. 7 women did not attend surgery and 3 records were not available (< 10%). Loss to follow‐up: at 12 months only 47% of patients filled out the questionnaire
Selective reporting (reporting bias)	Unclear risk	Insufficient information available
Other bias	Low risk	No other bias identified

Marana 1999.

Study characteristics
Methods	Multicentre study (n = 4), parallel‐group design Duration: October 1995 to November 1996 (1 year, 1 month) Randomisation: computer‐generated sequence Allocation concealment: not reported Blinding: no Number of womenrandomised: 116, number analysed 116. No dropouts. Follow‐up: until patient left hospital. Postoperative follow‐up included evaluation of pain on postoperative days 1, 2 and 3, length of postoperative hospital stay and evaluation of postoperative complications. No loss to follow‐up. Power calculation for sample size: yes. The sample size was selected to detect a difference of 25% in total complication rates with a power of 80% at the 5% level of significance, given a complication rate in the control group of 42%.
Participants	116 women with a mean age of 49 years Inclusion criteria: scheduled for AH for benign disease and had one or more of the following contraindications to VH: uterine size > 280 g and an upper limit of 16 weeks gestation (700 g); previous pelvic surgery; history of pelvic inflammatory disease; moderate or severe endometriosis; concomitant adnexal mass or indication for adnexectomy; and nulliparity with lack of uterine descent and limited vaginal access Exclusion criteria: suitable for VH
Interventions	AH versus LH (LAVH) LAVH arm: 10 mm laparoscope introduced through the umbilicus, and 3 accessory 5 mm reusable trocars were introduced suprapubically. The pelvis and upper abdomen were then accurately evaluated, and endometriotic lesions, adhesions or ovarian cysts, when present, were treated appropriately. When the ovaries were to be conserved, bipolar forceps and scissors were used to resect the round and uteroovarian ligaments with the fallopian tubes For adnexectomy, bipolar forceps and scissors were used to resect the round and infundibulopelvic ligaments, mesosalpinx and mesovarium. Opening of the bladder flap was performed at the laparoscopic phase, whereas bladder dissection was performed during the vaginal phase. Laparoscopic haemostasis was achieved using exclusively bipolar electrocoagulation. The vaginal phase included circular incision of the vagina; bladder dissection to the laparoscopically opened bladder flap; entry in the posterior cul‐de‐sac; and clamping, transecting and suture ligating of uterosacral ligaments, base of cardinal ligaments and uterine vessels. Where necessary, wedge morcellation, coring or bivalving was performed. Peritoneal closure with pedicles exteriorised and closure of vaginal vault anchored to the uterosacral and cardinal ligaments concluded the vaginal phase. AAGL LAVH classification: IA AH arm: performed according to the technique described by Mattingly and Thompson Surgeon experience: not reported Antibiotic prophylaxis: all received intravenous piperacillin 2 g administered 30 minutes before surgery Postoperative medication consisted of the administration of ketorolac by intramuscular injection or by mouth every 6 hours for the first 24 hours
Outcomes	Blood loss; postoperative fever; postoperative pain; length of postoperative hospital stay; postoperative complications; haemoglobin reduction and intraoperative conversion to abdominal surgery
Notes	Italy 4 university hospitals Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Insufficient information available
Other bias	Low risk	No other bias identified

Miskry 2003.

Study characteristics
Methods	2‐centre study, parallel‐group design Duration of trial not stated Randomisation: computer‐generated in blocks of 10 Allocation concealment: sequentially numbered, sealed, opaque envelopes, opened by nursing staff immediately prior to surgery Blinding: double‐blind until discharge from hospital, maintained by a sham opaque lower abdominal dressing (unless pyrexia or other complication necessitated direct inspection of the abdomen) and vaginal staining with methylene blue in cases undergoing VH Number of womenrandomised: 36, number analysed = 36. No dropouts. Follow‐up: follow‐up at 6 weeks and 6 months with completion of SF‐6 Short Form general health survey. Loss to follow‐up not clearly described. Power calculation for sample size: yes; 36 women required for 80% power to show a 2‐day difference in hospital stay at P = 0.05
Participants	36 women with a mean age of 42 years Inclusion criteria: scheduled for elective hysterectomy Exclusion criteria: genital tract malignancy; adnexal pathology; uterine size > 14 weeks; need for concurrent procedure (e.g. vaginal repair, colposuspension); reduced uterine mobility on VE; inadequate vaginal access
Interventions	AH versus VH Total hysterectomy performed by standard technique for each route. Low transverse incision, closed with subcuticular absorbable suture, for AH; Heaney technique for VH. In all cases, concurrent oophorectomy performed if indicated; peritoneal and vaginal vault closed. Surgeons: performed by most senior surgeon available All GA plus caudal block for one VH case Antibiotic prophylaxis co‐amoxiclav 1.2 g at induction of anaesthesia. Thrombo‐prophylaxis heparin 5000 units at induction and twice daily until mobile.
Outcomes	Primary outcome: duration of hospital stay Secondary outcomes: analgesic requirements; complications; return to normal function
Notes	UK Royal Free and North Middlesex Hospitals Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised by computer
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	Low risk	Sham abdominal dressing until discharge blinded patients and outcome assessors. Surgeon not blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No dropouts; loss to follow‐up not clearly described
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes were adequately reported
Other bias	Low risk	No other bias identified

Mohammed 2017.

Study characteristics
Methods	Single‐centre randomised controlled trial Duration: from July 2014 to September 2016, 26 months Randomisation: randomisation procedure was based on a computer‐generated list Allocation concealment: using serially numbered, opaque, sealed envelopes Blinding: no Number of women: 50 Follow‐up: only short term, until discharge Power calculation for sample size: not reported
Participants	Mean age in the VH group was 48.44 and 47.72 in the LAVH group Inclusion criteria: age ranging between 40 and 70 years, the presence of a benign cause for hysterectomy and uterine weight more than 280 g Exclusion criteria: obese patients (BMI 30), those with history of endometriosis or previous myomectomy, patients with suspected or known gynaecological malignancy, and cases with severe cardio‐pulmonary compromise were excluded from the study; cases with estimated uterine weight more than 700 g
Interventions	VH verus LAVH LAVH: a blunt tipped uterine manipulator (Cohen manipulator) was inserted into the uterus through the cervix. Carbon dioxide insufflation was done via Veress needle inserted through the base of umbilicus. Four trocars were used: one 10 mm trocar was introduced through the base of umbilicus and three 5 mm trocars were introduced under vision lateral to the rectus muscle, two on the patients’ left side and on their right side. The round and the ovarian ligaments were coagulated using bipolar grasper and then divided by scissors, after proper visualisation of the ureter. The anterior leaflet of the broad ligament was opened with dissection through the vesico‐uterine space up to the level of the cervix. The uterine artery was secured laparoscopically, and then, anterior colpotomy was done also laparoscopically over the cup of the manipulator. The procedure was then completed vaginally, dealing with utero‐sacral and cardinal ligaments and closure of the vault after removal of the uterus via the vagina. All pedicles were inspected laparoscopically at the end of the procedure for any bleeding points. AAGL LAVH classification: IIID Surgeons: all operations were performed by the same 3 surgeons
Outcomes	Outcomes: the primary outcome measured was postoperative hospital stay, measured in hours from the day of the operation until discharge Secondary outcomes: operative time, intraoperative blood loss, hospital costs, intraoperative or postoperative complication
Notes	Ain Shams University Hospital 50 procedures in 26 months by 3 surgeons
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation procedure was based on a computer‐generated list
Allocation concealment (selection bias)	Low risk	Serially numbered, opaque, sealed envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding of patient or surgeon
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low attrition
Selective reporting (reporting bias)	Low risk	No selective reporting bias identified. All predefined outcome measures have been described.
Other bias	Unclear risk	No power calculation They report that 3 surgeons performed all procedures but do not comment on their experience with either method

Mustea 2019.

Study characteristics
Methods	Prospective, randomised, multicentre trial; 60 patients from 3 centres in Germany Duration: not described Randomisation: 1:1 randomisation, not specified Allocation concealment: not described Blinding: only the patient was blinded; it was not mentioned if the doctor or surgeon was blinded during follow‐up Number of women: 60 women were randomised Follow‐up: until 2 months postoperatively, no loss to follow‐up described Power calculation for sample size: no power calculation mentioned in the paper
Participants	Conventional LH (n = 32) or single port hysterectomy (n = 30) Mean age in the conventional group was 46.5 years old, mean age in the SP‐LH hysterectomy group was 45.0 years old Inclusion criteria: only patients with benign diseases were included in this trial Exclusion criteria: patients were excluded from this trial if they had a lower midline incision, were undergoing peritoneal dialysis, had an ASA class > 3, prior umbilical hernia repair or malignancy of the female genital tract
Interventions	LH versus laparo‐endoscopic single‐site surgery (LESS or SP‐LH) hysterectomy All surgeons performed the same technique LAVH, using SILS™ Port or conventional laparoscopy. The following advised products, at least one Cambridge articulating instrument, were used during each surgery: SILSPT12, LF5544, SILSDISSECT36, 5 mm or 10 mm laparoscope of choice. 5 mL of 1% Xylocaine injected into the skin at the conclusion of the procedure. Surgeon experience: all participating surgeons were certified as MIC‐II‐III by the German Study Group for Gynaecologic Endoscopy (Arbeitsgemeinschaft Gynäkologische Endoskopie: AGE)
Outcomes	The authors state that they "particularly focused on safety and effectiveness of both techniques" but do not describe any predetermined outcomes
Notes	4 patients were excluded because of screening failures
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	They state randomisation was performed but do not describe how
Allocation concealment (selection bias)	Unclear risk	No information about allocation concealment was reported
Blinding (performance bias and detection bias) All outcomes	Low risk	It was mentioned that the patients were blinded by using sterile dressings on traditional laparoscopy sites in both groups until 1 week after the surgery
Incomplete outcome data (attrition bias) All outcomes	High risk	Little information about the inclusion criteria and no information about loss to follow‐up are reported
Selective reporting (reporting bias)	Unclear risk	No predefined outcome measures, no study protocol published
Other bias	High risk	Different numbers of participants are mentioned; no power calculation reported; not clear how long the inclusion period was. They do report on surgeon experience.

Muzii 2007.

Study characteristics
Methods	Multicentre study, parallel‐group design Duration: January 2005 to December 2005 (1 year) Randomisation: computer‐generated allocation list; in operating room Allocation concealment: numbered, sealed, opaque envelopes Blinding: no Number of women eligible: 86. Number of women randomised = 81. There were no dropouts. Conversions to AH: 2 in LAVH group and 4 in minilaparotomy group Follow‐up: women were followed up until discharge. No loss to follow‐up. Power calculation was performed for sample size. Actual sample size was necessary to detect a difference in complications between the 2 groups of 30% (complication rate 42% in control group) with 80% power with a significance level of 0.05 Intention‐to‐treat analysis was possible from the data but not performed by the authors for all outcomes
Participants	81 women with a mean age of 49 years in the LAVH group and 48 years in the minilaparotomy group Inclusion criteria: benign disease: myoma and/or abnormal uterine bleeding with and without adnexal masses. Contraindication for vaginal hysterectomy. Exclusion criteria: uterine size greater than 700 g on ultrasound, previous midline incision, absolute contraindication to laparoscopy
Interventions	LAVH versus minilaparotomy LAVH: 4‐port technique, laparoscopic dissection with bipolar forceps and scissors of either round and utero‐ovarian ligaments or infundibulo‐pelvic ligaments. Opening bladder flap, followed by vaginal hysterectomy. Uterosacral/cardinal ligament complex was anchored vaginally to vaginal vault. Laparoscopy at the end of the procedure. AAGL LAVH classification: IB Minilaparotomy: Trendelenburg position, 4 cm to 9 cm transverse incision, moving operative window with 3 retractors. Ligaments cut after electrocoagulation, whereas vascular pedicles clamped, ligated and cut. Vaginal vault abdominally closed with running suture and suspension to uterosacral/cardinal ligament complex. Surgeons: experience not reported Prophylactic antibiotic treatment: first‐ or second‐generation cephalosporin IV GA for both LAVH and mini‐laparotomy
Outcomes	Primary outcome: overall complications Secondary outcomes: operative time; conversions; haemoglobin drop (day 1); VAS pain (day 1 and 2); time to return bowel function; hospital stay
Notes	Italy 3 university hospitals in Rome Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list
Allocation concealment (selection bias)	Low risk	Numbered, sealed, opaque envelopes in operating room
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Insufficient information available
Other bias	Low risk	No other bias identified

Nanavati 2016.

Study characteristics
Methods	Single tertiary centre study Duration: 18 months Randomisation: 150 consecutive patients were randomly selected for any of the 3 routes of surgery. No further information provided. Allocation concealment: not described Blinding: no Number of women randomised: 150 women. No conversion. Follow‐up: duration of follow‐up is not clear in this study; however, t seems that there was no loss to follow‐up Power calculation for sample size: no
Participants	150 women, age is not provided Inclusion criteria: non‐malignant conditions, having no adnexal masses, having no severe endometriosis, having descent of no more than 1st degree of uterus, uterine size ≤ 12 weeks
Interventions	TAH, VH and LH hysterectomies Procedure methods not described Surgeons: carried out by surgeons of similar calibre at teaching institute
Outcomes	No distinction made between primary and secondary outcomes Outcomes: intraoperative and postoperative complications, time taken for surgery, blood loss, postoperative pain and mobilisation, duration of hospital stay
Notes	India No information about funding of the study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information provided about type randomisation
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not described
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding efforts described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Follow‐up time is not specified. For more long‐term complications only absolute numbers are presented, instead of proportions, therefore not possible to determine if patients were lost to follow‐up
Selective reporting (reporting bias)	Unclear risk	Some essential elements are not reported or described, so risk is unclear
Other bias	High risk	Procedures are not described. Baseline characteristics of participants were not reported, aside from indication for surgery, therefore it is not possible to determine if groups were comparable No sample size calculation

Olsson 1996.

Study characteristics
Methods	Single‐centre, parallel‐group design Duration: not reported Randomisation: 1:1 ratio; method not reported Allocation concealment: sealed, opaque envelopes Blinding: no Number of women randomised: 143, number analysed = 143. No dropouts. Follow‐up: 4 to 6 weeks after surgery, all patients returned for a gynaecological examination including vaginal ultrasound. 6 to 8 weeks after surgery patients were asked to complete an anonymous questionnaire about whether they considered the duration of their postoperative hospital stay and sick leave to have been adequate. In a subgroup of patients (TLH: n = 38; AH: n = 38), postoperative health status and quality of life were self‐assessed prospectively 1, 3 and 12 weeks after surgery using "The Medical Outcome Trust 36‐item Short‐Form Health Survey questionnaire". Loss to follow‐up not described. Power calculation for sample size: yes; assuming a complication probability of 40% for AH, the power of predicting a difference in complication rate was at least 80% at the 5% level, 2‐sided test, provided that the probability of complications following LH(a) is at most 18% and at least 64% when 70 patients are included in each group
Participants	143 women with median age 48 years Inclusion criteria: scheduled for AH for benign disorders, with a maximum uterine width of less than 11 cm and not considered suitable for VH Exclusion criteria: suitable for VH (adnexa are not to be removed; no suspicion of endometriosis or post‐inflammatory disorders, when uterine size is normal, or in the case of uterovaginal prolapse, less than the size of an 8‐week pregnancy)
Interventions	AH versus LAVH LAVH arm: all patients were prescribed a second‐generation cephalosporin as well as metronidazole intravenously during the operation and by oral administration for 2 days after surgery. Ureters were identified, where this was difficult, the ureters were dissected free down to the level of the uterine arteries. If the adnexa were to be removed, the infundibulopelvic ligaments were transected by diathermal cautery and monopolar scissors. If the adnexa were to be conserved the utero‐ovarian pedicles were transected on both sides, using the same instruments. The round ligaments and the upper portion of the broad ligaments were divided using monopolar scissors and the bladder was dissected to the level just below the vaginal cuff. The posterior part of the broad ligaments were divided by scissors close to the uterus, down to the upper part of the uterosacral ligaments, which were then transected. The uterine arteries were transected close to the uterus after bipolar coagulation. The upper portion of the cardinal ligaments were divided close to the uterus, after which an incision was made into the anterior fornix of the vagina. The vaginal phase: vaginal epithelium surrounding the cervix was transected as well as any residual tissue from the cardinal and uterosacral ligaments. The transected ligaments were ligated together and incorporated into the vaginal wall. AAGL LAVH classification: IIIB AH arm: antibiotics were not routinely prescribed in this group of patients. They underwent either a lower midline or Pfannenstiel incision. If the adnexa were to be removed, the infundibulopelvic ligaments were clamped, transected and ligated. In cases where the adnexa were not to be removed, the utero‐ovarian pedicles were transected and ligated. The anterior broad ligaments were divided down to the vesico‐vaginal junction and the bladder reflected to just below the vaginal cuff. The uterine vessels were divided close to the uterus. Following division of the cardinal and uterosacral ligaments, the uterus was excised. The vaginal cuff was closed with interrupted sutures and the peritoneal layers closed and attached to the top of vagina Surgeons: 2 out of 5 surgeons of senior registrar grade and specifically trained in LH(a); 2 out of 10 surgeons of senior registrar grade trained in AH
Outcomes	Operating time (minutes); complications; postoperative pain relief; convalescence (sick leave); hospital stay; quality of life; economic analysis (cost)
Notes	Sweden University Hospital of Sahlgrenska Funding: Goteborg Medical Society Fund, Swedish Medical Research Council
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No dropouts; loss to follow‐up unknown
Selective reporting (reporting bias)	Low risk	Primary outcomes clearly defined and reported
Other bias	Low risk	No other bias identified

Ottosen 2000.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: January 1996 to May 1998 (2 years, 5 months) Randomisation: computer‐generated numbers. Randomly allocated to one of 3 operating methods in 4 blocks of 30 to ensure a balanced number of patients throughout study period. Interim analysis done after 25 patients were randomised to each group. Allocation concealment: sealed, opaque envelopes prepared by and successively opened by the research nurse Blinding: no Number of women randomised: 120, number analysed = 120. No dropouts. Follow‐up: 2 weeks postoperatively in outpatient clinic for examination to detect complications and evaluate need for further sick leave. No loss to follow‐up. Power calculation for sample size: yes; sample size based on reported hospital stay for vaginal and abdominal hysterectomy of 2.3 and 4 days, respectively. If 1.5 is the SD for hospital stay, 40 women were randomised to achieve a power of 80% at alpha = 0.05. Intention‐to‐treat analysis: yes
Participants	120 women with a mean age of 47 years (AH group), 49 years (VH group) and 48 years (LAVH group) Inclusion criteria: scheduled for hysterectomy for anticipated benign causes. Inclusion: menorrhagia, leiomyomas < 15 cm in diameter, dysplasia, endometrial atypia and pain Exclusion criteria: ovarian pathology, uterus larger than 16 weeks of gestational size, previously known dense adhesions, narrow vagina or obvious inaccessible uterus
Interventions	AH versus VH versus LAVH ‐ 3 treatment arms LAVH arm: the laparoscopic part was minimised. Trocars were left in place and after closing the vaginal wall the surgeon returned to laparoscopic view to confirm haemostasis. The surgery was performed under GA in 109/120 cases, spinal block in 3/120 or in combination with epidural block in 8/120 cases. AAGL LAVH classification: varied; 20 of 40 LAVHs were type 0 meaning only diagnostic laparoscopy was performed before vaginal surgery AH arm: the abdomen was opened and closed in different ways according to surgeon preference. The uterus was removed by extrafascial technique and the vagina closed and covered by peritoneum. VH arm: the vault was injected with 20 ml of mepivacain/adrenalin before incision in order to minimise bleeding. The peritoneal folds were opened and ligaments and uterine vessels were divided. If at this time the uterine size did not allow easy exteriorisation, bisecting, coring, morcellation, enucleation or combinations of these volume‐reducing techniques were performed. The peritoneum was closed, followed by suturing of the sacrouterine ligaments and vaginal vault. Surgeons: 1 of 15 gynaecological surgeons; experience varied and in some cases residents performed under supervision Antibiotics: all patients had at least 1 dose of prophylactic antibiotic perioperatively: cefuroxime 1.5 g intravenously and metronidazole 1 g rectally. A daily dose of enoxaparin 20 mg subcutaneously was given as thrombotic prophylaxis through the hospital stay.
Outcomes	Duration of surgery, duration of anaesthesia, stay in hospital, recovery time, perioperative blood loss and complications
Notes	Sweden Hospital of Helsingborg Funding: Thelma Zoegas Foundation and the Stig and Ragna Gorthons Foundation, Sweden
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised by computer
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Low risk	Primary outcome defined
Other bias	Low risk	No other bias; no differences between the 3 groups regarding patients' characteristics. Surgeons' experience varied

Panda 2015.

Study characteristics
Methods	Single‐centre study Duration: June 2011 to December 2012 (19 months) Randomisation: simple randomisation on 150 consecutive patients requiring hysterectomy for benign indications Allocation concealment: not described Blinding: no Number of women randomised: 150 women Follow‐up: not clear Power calculation for sample size: no
Participants	145 women with a mean age of 40.84, 41.44 and 44.57, respectively Inclusion criteria: uterine size was ≤ 14 weeks and operation was performed for a benign uterine condition Exclusion criteria: primary diagnosis was related to malignancy, pelvic endometriosis and prolapse
Interventions	AH, VH and LH Procedures are not described. Some form of added procedures was performed in all routes of hysterectomy, such as concurrent salpingo‐oophorectomy, adhesiolysis, cystectomy.
Outcomes	No distinction made between primary and secondary outcomes Outcomes: operating time, haematocrit fall, consumption of analgesia, length of hospital stay and rate of complications
Notes	India No information about funding of the study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information provided about randomisation
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not described
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There seems to be no loss to follow‐up. However, 4 women in the LAVH group and one in the vaginal group were converted to the abdominal route and considered failure of procedure. It seems that they were omitted from the analysis, instead of being analysed according to intention‐to‐treat.
Selective reporting (reporting bias)	Unclear risk	No defined primary outcome
Other bias	High risk	Although participants were randomised, demographic characteristics are significantly different between groups; 20% versus 4% had a Caesarean section in the AH group (selection bias) No sample size calculation has been done. Also, it is not clearly indicated what the primary outcome was in this study. Procedures are not described. Were they all done by the same surgeon? Was there a protocol for each procedure?

Paraiso 2013.

Study characteristics
Methods	Multicentre study (2 institutions) Duration: June 2007 to March 2011 (45 months) Randomisation: stratified by surgeon and uterine size (> or ≤ 12 weeks). Participants were assigned randomly according to a computer‐generated randomisation schedule with random block sizes. Allocation concealment: not described Blinding: yes; patients were blinded to their assignment as were those performing postoperative assessments Number of women randomised: 75 women. In both arms 6 cases dropped out before the intervention was performed. Follow‐up: no loss to follow‐up Power calculation for sample size: yes, 23 participants per arm were needed to detect a difference of ≥ 30 minutes in operating time between conventional versus robotic‐assisted TLH with 90% power and a significance level of 0.05 Intention‐to‐treat analysis applied (converted procedures analysed in original allocated arm)
Participants	53 women with a mean age of 45.6 and 43.8 respectively Inclusion criteria: ≥ 18 years old, hysterectomy for benign conditions Exclusion criteria: suspected malignancy, medical illness that precluded laparoscopy, inability to give informed consent, morbid obesity (BMI > 44) or need for concomitant bowel resection
Interventions	TLH and robotic‐assisted TLH Conventional: 4 ports Robotic‐assisted: performed with the Da Vinci Surgical System with an umbilical port for laparoscopic camera, one 10/12 mm port placed in the right of left subcostal area lateral to the rectus for suture introduction, 2 x 8 mm robotic ports placed in the bilateral lower quadrants and one 5 mm port 8 cm inferior to right or left subcostal margin The technique to perform the hysterectomy was performed in both arms in a standard fashion, with the entirety of the hysterectomy performed laparoscopically Vaginal cuff closures: not described Surgeons: 5 experienced laparoscopists: 75 to 400 LH and at least 20 RH
Outcomes	Primary outcomes: total case time from incision to closure Secondary outcomes: intra‐ and postoperative complications, the impact of surgery on daily living and narcotic use for 6 weeks
Notes	USA Cleveland Clinic Supported by a grant from the Cleveland Clinic Center for Surgical Innovation, Teaching and Education
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was stratified by surgeon and uterine size (> or ≤ 12 weeks). Participants were assigned randomly according to a computer‐generated randomisation schedule with random block sizes
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not described
Blinding (performance bias and detection bias) All outcomes	Low risk	Patients were blinded to their assignment as were those performing postoperative assessments. Surgeons were not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up. In both arms 6 cases dropped out before the intervention was performed
Selective reporting (reporting bias)	Low risk	No reporting bias identified
Other bias	Low risk	No other bias. Stratified by surgeon and uterine size

Park 2021.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: not reported Randomisation: randomisation table generated using a web‐based program, assigned at a ratio of 1:1 Blinding: investigator and patients blinded Number of women eligible and randomised = 26 Dropouts: there were no dropouts or conversions Follow‐up: not reported Power calculation for sample size: yes. It was planned to enrol a total of 26 patients considering the dropout rate of 10%. Analysis by intention‐to‐treat: not reported
Participants	26 women with a mean age of 54 years in the V‐NOTES group and 48 years in the LESS group Inclusion criteria: required hysterectomy because of benign uterine disease or abnormal uterine bleeding; age above 19 years or under 80 years; suitable for endoscopic surgery evaluated by the American Society of Anesthesiologists Physical Status (ASA) classification 1 or 2; signed informed consent Exclusion criteria: age less than 19 years or above 80 years; pregnant or breastfeeding; no history of sexual intercourse; suspected of pelvic malignancy; women who have received 3 or more Caesarean sections; suspected of posterior cul‐de‐sac obliteration by gynaecological examination
Interventions	V‐NOTES vs LESS V‐NOTES arm: vaginal incision was made around the cervix, after which the vesicouterine and the rectouterine pouch were developed, and bilateral uterosacral ligaments were incised. After insertion of One Port Plus (MEDIFINE Corporation Co., Ltd, Gyeonggi‐do, Korea) through the vagina, carbon dioxide (CO2) gas was infused with a pressure of 12 mmHg. A 10 mm rigid laparoscope was used (Karl Storz, Tuttlingen, Germany), and both parametrium and uterine arteries were coagulated and cut with the energy device. After the hysterectomy was completed, vaginal cuff closure was done extracorporeally with continuous locking suture with 1–0 Vicryl. LESS arm: a single umbilical incision of 2 cm was made, and the surgeon used the open technique to approach the peritoneal cavity. One Port Plus was inserted to the umbilical incision, and a 5 mm rigid 30° laparoscope (Karl Storz, Tuttlingen, Germany) was used. Hysterectomy was performed, and the specimen was withdrawn through the vagina. After that, vaginal cuff closure was done intracorporeally with barbed suture. Surgeons: all surgeries were performed by the same gynaecologist Anaesthetics: PCA composed of 1000 μg of fentanyl without basal flow, with a bolus amount of 10 μg with lockout time of 6 minutes
Outcomes	Postoperative abdominal and vaginal pain at 24 hours after surgery by NRS score NRS pain score recorded every 8 hours up to 48 hours post‐surgery; the frequency of additional analgesics administered; maintenance rate of PCA at the time of postoperative pain evaluation; estimated blood loss; transfusion; postoperative haemoglobin level at 24 hours after surgery; days of hospitalisation; postoperative complications; rate of reoperation within 6 weeks
Notes	Korea
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A reproducible randomisation table was generated using a web‐based program and managed by a third‐party gynaecologist unrelated to the study
Allocation concealment (selection bias)	Unclear risk	Not reported. Assignment revealed to patient and surgeon immediately prior to surgery.
Blinding (performance bias and detection bias) All outcomes	High risk	Randomisation results were disclosed to both the investigator and the study subject due to the nature of the intervention
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Follow‐up time not reported. Loss to follow‐up not specifically reported, though based on Figure 1 it appears there was none.
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes defined
Other bias	High risk	Analysis according to intention‐to‐treat unclear, though it appears there were no conversions or losses to follow‐up. Duration of trial not reported. Single surgeon described as expert. The procedure protocol was reported and standardised.

Parveen 2013.

Study characteristics
Methods	Single‐centre study Duration: June 2012 to May 2013 (11 months) Randomisation: the selected patients were placed randomly into 2 equal groups i.e. group I and group II, by using random number tables. First, all the patients were consecutively assigned to one group and then to the next group Allocation concealment: not described Blinding: no Number of womenrandomised: 76 women Follow‐up: no loss to follow‐up. Minimum follow‐up period was 1 week and 4 weeks with mean follow‐up of 1.25 ± 0.70 weeks for group I and 1.79 ± 2.12 weeks for group II. Power calculation for sample size: no
Participants	76 women with a mean age of 53.89 and 50.23, respectively Inclusion criteria: requiring hysterectomy for benign pathology with uterus of less than 14 weeks size, utero‐vaginal prolapse or those with failed medical treatment in dysfunctional uterine bleeding Exclusion criteria: patients in whom indication for hysterectomy was malignancy, endometriosis, pelvic inflammatory disease, cardiac diseases, bronchial asthma and those with conversion of vaginal hysterectomy to abdominal hysterectomy
Interventions	VH and AH All the hysterectomies were performed by same consultant gynaecologist Prophylactic IV antibiotics i.e. injected co‐amoxiclav (40 mg/kg/day) and injected gentamycin (5 mg/kg/day), were given and continued for 3 days postoperatively in every patient No further information provided about execution of the procedures
Outcomes	No distinction made between primary and secondary outcomes Outcomes: operative time in minutes Perioperative complications: bladder or ureteric injury and haemorrhage. Postoperative complications: wound infection, paralytic ileus, urinary tract infection and vaginal vault haematoma/infection
Notes	Bahawal Victoria Hospital/Quaid‐e‐ Azam Medical College, Bahawalpur No information about funding
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Little information given about the randomisation procedure, though it does state the selected patients were placed randomly into 2 equal groups, i.e. group I and group II, by using random number tables
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not described
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding performed
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Some essential elements are not reported or described and there are no pre‐defined primary outcomes
Other bias	High risk	Significant difference in age after randomisation No information provided about how procedures are conducted No sample size calculation performed As there are several suboptimal elements in this design: we consider the risk of ‘other bias’ as high

Perino 1999.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: January 1997 to 30 September 1998 (1 year, 9 months) Randomisation: method not stated and allocation concealment not reported Allocation concealment: not reported Blinding: no Number of womenrandomised: 102, number analysed = 102. No dropouts. Follow‐up: until women were discharged from hospital. Postoperative pain was assessed 3 days after surgery. No loss to follow‐up. Power calculation for sample size: no
Participants	102 women with a mean age of 48 years Inclusion criteria: scheduled for hysterectomy for benign diseases Exclusion criteria: not stated
Interventions	AH versus TLH TLH arm: after a CO2 pneumoperitoneum was created, a 10 mm trocar was placed in the umbilical site to introduce the laparoscope and the camera. 3 ancillary 5 m trocars were placed suprapubically. After an abdominal inspection, lysis of any adhesions was performed, the uterus was then mobilised. After bipolar coagulation, the round ligament was sectioned at 3 cm from the uterus. The areolar tissue of the broad ligament was then dissected and its posterior fold fenestrated at an avascular area above the uterine vessels. The infundibulo‐pelvic ligament vessels were coagulated and cut using bipolar forceps and scissors under direct visualisation of the pelvic ureter. Once the uterine ligaments were sectioned, the operation continued centrally in a downward direction. If the adnexae were not to be removed, the utero‐ovarian ligament was coagulated and sectioned proximal to the ovaries. The vesico‐uterine peritoneal fold was opened by scissors and a bladder dissection from the low uterine segment down to the upper part of the vagina was performed. The utero‐sacral ligaments were then coagulated and sectioned. The uterine artery was skeletonised and then coagulated with bipolar forceps and cut with scissors. Incision and coagulation of the cardinal ligaments to expose the vaginal fornices, separated from the stump of the uterine artery. Circular colpotomy was then performed and the uterus was removed from the vagina. TLH vaginal cuff closure: the vaginal vault was then sutured laparoscopically or vaginally AH arm: performed according to the technique described for benign disease (Mattingly and Thompson) Intravenous pain relief was given postoperatively Surgeons: all operations performed by the same team of 3 surgeons with experience of 100+ TLH procedures
Outcomes	Operating time; blood loss; postoperative pain; postoperative decrease in haemoglobin; complications and duration of postoperative hospital stay
Notes	Italy Gynaecologic University Hospital of Palermo Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Primary outcome not defined
Other bias	Low risk	No power calculation reported, no other bias identified

Persson 2006.

Study characteristics
Methods	Multicentre study, parallel‐group design Duration: October 1996 to May 2003 (5 years, 6 months) Randomisation: block randomisation (according random table) Allocation concealment: sealed, opaque envelopes Number of women eligible = 1360, randomised = 125; 1 dropout: withdrew before consent. In the LH group, there were 3 intraoperative conversions to AH. Follow‐up: women were followed up until 6 months after surgery; 5 were lost to follow‐up: in the LH group 1 woman withdrew consent before the 5 weeks follow‐up, and 4 women in the AH group withdrew consent before the 5 weeks follow‐up. Power calculation for sample size: 60 patients per group were necessary to detect a difference between the 2 groups of 10 units or more on the PGWB with 90% power, a significance level of 0.05 and a dropout rate of 20% Analysis was by intention‐to‐treat
Participants	119 women with a mean age of 44 years in both groups Inclusion criteria: women with benign disease, LH was feasible, fluent in Swedish Exclusion criteria: genital tract malignancy, pre‐operative GnRH analogues, postmenopausal women without HRT, psychiatric disorders
Interventions	AH versus LAVH AH: performed by Pfannenstiel incision and according to the extrafascial technique LAVH procedure: done with a 3‐port technique. Parametrium and uterine artery were sealed laparoscopically with bipolar coagulation or stapling. Cardinal and uterosacral ligaments as well as suturing of vaginal cuff vaginally. In both procedures the vaginal cuff was anchored to the uterosacral ligaments without peritonealisation. AAGL LAVH classification: IIA Antibiotics: both groups received prophylactic antibiotic treatment (cefuroxime 1.5 g and metronidazole 1 g IV) Surgeon experience: (supervising) surgeons were skilled and experienced
Outcomes	Primary outcome: psychological well‐being (questionnaires PGWB) Secondary outcomes: questionnaires WHQ, STAI, BDI; operative time; complications, conversions to AH; hospital stay; return to normal activities
Notes	Sweden 2 county hospitals, 2 central hospitals and 1 university hospital in the southeast Funding: grants from the Medical Research Council of South East Sweden
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	According to random table
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	1 dropout after randomisation and 5 lost to follow‐up were not analysed (1 LH and 5 AH group), i.e. < 5%. It is not clear how many women were lost to follow‐up after 6 months
Selective reporting (reporting bias)	Low risk	Primary outcome predefined
Other bias	Unclear risk	Only 9% of eligible patients were randomised

Raju 1994.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: March 1992 to October 1993 (1 year, 8 months) Randomisation: containing computer‐generated block randomisation numbers. Block size of 10. Allocation concealment: sealed envelopes Blinding: no Number of women randomised: 80, number analysed = 80. No dropouts. Follow‐up: 6 weeks after surgery and until women return to work. No loss to follow‐up. Power calculation for sample size: yes, 40 patients in each arm were estimated to detect a 25% difference in morbidity between the groups, with a power of 90% at the 5% level
Participants	80 women with a mean age of 46 years Inclusion criteria: scheduled for hysterectomy and bilateral oophorectomy for benign conditions Exclusion criteria: morbid obesity, uterus larger than 14 weeks gestation size or uterovaginal prolapse
Interventions	AH + BSO versus LAVH+ BSO LAVH + BSO arm: 5.5 mm flap‐valved trocars were inserted enabling the insertion of laparoscopic instruments. 12 mm trocar and cannula were introduced suprapubically in the midline 3 cm above the upper border of the symphysis pubis as a port for the use of the Autosuture Multifire Endo GIA 30 stapling device. The cervix was grasped with a vulsellum and a broad‐ended blunt uterine curette was inserted to manipulate the uterus from the perineal end. Any adhesions between the uterus or adnexae to adjacent structures were divided with scissors after diathermy coagulation. Both round ligaments were treated with diathermy and cut with scissors approximately 3 cm from the internal inguinal ring whilst holding the ligament with a grasping forceps. The peritoneum of the anterior leaf of the broad ligament was dissected from the divided round ligament back towards the infundibulo‐pelvic ligament thus opening the tissue space between the 2 folds of broad ligament. The posterior leaf of the broad ligament was then pierced with endoshears to make a window, a safe distance above the ureter which had been previously identified. The ovarian pedicle was then sized for thickness of tissue by means of a GIA endo gauge inserted through the midline suprapubic incision. The correct size of endo stapling clamp was selected. The ovarian pedicle was clamped and cut with the appropriate GIA endo stapling device, placed from the upper border of the infundibulo‐pelvic ligament and with the jaws of the stapler passing well through the peritoneal window in the broad ligament. By using this technique each ovarian pedicle required only one firing of the GIA stapler to divide it. Finally, the uterovesical fold of the peritoneum was divided with scissors and sometimes the uterosacral ligaments were divided after diathermy coagulation. The uterus, tubes and both ovaries were then removed vaginally after circumcising the cervix and opening the pouch of Douglas to allow ligation and division of the cardinal ligaments and uterine vessels as in a traditional vaginal hysterectomy. The vaginal vault was anchored to the cardinal ligaments and closed with interrupted sutures AAGL LAVH classification: I AH+BSO arm: procedures were performed using a standard technique Operations were performed by one of the authors or by another surgeon of senior registrar grade Surgeons: operations performed by one of the authors. Experience unknown. Premedication: temazepam 20 mg, 2 hours before operation. GA induced with thiopentone and maintained with enflurane and nitrous oxide. Under anaesthesia a bolus intravenous injection of amoxicillin clavulanate (Augmentin) 1.2 g was given. Antibiotic therapy continued for 7 days postoperatively.
Outcomes	Operating time, blood loss, haemoglobin change, hospital stay, postoperative analgesia, complications, recovery time (subjective assessment of patient's general well‐being and return to normal activity) and cost
Notes	UK St Thomas's Hospital, London Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised by computer
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Insufficient information available
Other bias	Low risk	No other bias reported. Surgeon's experience unknown, but all surgeries performed by 1 surgeon

Ribeiro 2003.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: not reported Randomisation: method not stated Allocation concealment: not reported Blinding: no Number of womenrandomised: 60, number analysed = 60. No dropouts. Follow‐up: routinely up to 6 days. No loss to follow‐up. Power calculation for sample size: no
Participants	60 women with an overall mean age of 42.3 years (range 34 to 76 years) Inclusion criteria: benign uterine disease: myoma n = 41; adenomyosis n = 19 Exclusion criteria: uterine volume greater than 400 mL; use of any anti‐inflammatory medication during preceding 3 months; diabetes mellitus; coagulation disorders; autoimmune diseases
Interventions	AH versus VH versus TLH AH: by Thompson and Warshaw technique VH: by Heaney's technique TLH: 10 mm laparoscope inserted at umbilicus, 2 x 5 mm secondary ports for laparoscopic instruments. Uterine mobiliser with blunt tip used to antevert uterus and delineate vaginal fornices. Round ligaments divided with monopolar forceps and vesico‐uterine fold divided with scissors and bladder mobilised until anterior vagina identified. Utero‐ovarian ligament and fallopian tube pedicles desiccated with bipolar forceps, then scissors division of broad ligament peritoneum. Uterine artery grasped, elevated and bipolar coagulated. Cardinal and uterosacral ligaments divided with monopolar forceps. Vagina entered posteriorly near cervico‐vaginal junction. 4 cm vaginal delineator outlined circumferentially the cervico‐vaginal junction and prevented loss of pneumoperitoneum. Monopolar forceps completed the circumferential culdotomy. Uterus removed vaginally (after morcellation if necessary). Vaginal cuff closure: laparoscopic vaginal vault interrupted suturing and suspended by suture attachment to uterosacral/cardinal pedicles, sutures being tied extracorporally Surgeon experience: not reported Antibiotic and thrombo‐prophylaxis not specified
Outcomes	Operative time; pre and postoperative haemoglobin; complications
Notes	Brazil São Paulo University School of Medicine Hospital Funding: Foundation of Research Support from São Paulo State
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Primary outcome not clearly defined
Other bias	Low risk	No other bias identified

Richardson 1995.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: not reported Randomisation: random numbers table Allocation concealment: not reported Blinding: no Number of womenrandomised: 45, number analysed = 45. No dropouts. Follow‐up: 6 to 8 weeks after surgery, women completed a questionnaire on their recovery. All kept a prospective diary of their recovery for 6 weeks. No loss to follow‐up. Power calculation for sample size: no
Participants	45 women with a mean age of 41 years (LH group) and 45 years (VH group) Inclusion criteria: contraindications for vaginal surgery according to traditional criteria (absence of vaginal prolapse, nulliparity, uterine enlargement, previous pelvic surgery endometriosis and need for oophorectomy) Exclusion criteria: uterine size greater than the equivalent of 16 weeks' gestation, endometrial carcinoma, adnexal masses, known dense pelvic adhesions or moderate/severe endometriosis
Interventions	VH versus LH LH arm: the laparoscope was inserted sub‐umbilical incision, and usually 2 x 5 mm secondary portals were used for the laparoscopic instruments. Surgery was performed under the guidance of the image generated by a Supercam 9050 PB video chip camera attached to a 30 degree forward oblique laparoscope. The principal method of haemostasis was bipolar electrosurgical desiccation but Endo‐GIA 30 linear staplers were used in 8 women. In 1 woman VH was done after diagnostic laparoscopy (stage 0 VH) and in 2 VH was carried out after laparoscopic adhesiolysis had made this possible (stage 1 LH). When the ovaries were conserved, bipolar diathermy was used medially to desiccate the round and ovarian ligaments, and the fallopian tube. The approach to the ovarian pedicle during oophorectomy depended on whether the uterine vessels were to be divided laparoscopically or vaginally. If divided vaginally, the ovarian vessels were coagulated and divided but not the round ligaments. Dissection then proceeded towards the uterine origin of the round ligament, after which the hysterectomy was completed vaginally (stage 2 LH) or after laparoscopic mobilisation of the bladder (stage 3 LH). If the uterine vessels were treated laparoscopically (stage 4 LH), the round ligaments were always divided, together with the ovarian vessels and fallopian tubes, and the dissection continued to the level of the uterine arteries which were then desiccated and cut close to the uterus. Laparoscopic dissection only continued further than the uterine artery in 3 cases (stage 5 LH), all other procedures being completed vaginally AAGL LAVH classification: I‐IV VH arm: modified Heaney approach Surgeon experience: not reported
Outcomes	Operating time; analgesia required; hospital stay; recovery time and postoperative complications
Notes	UK Royal Free Hospital, London Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random numbers table
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Primary outcome not defined; insufficient information available
Other bias	Low risk	No other bias identified

Roy 2011.

Study characteristics
Methods	Duration: April 2007 to June 2009 (2 years, 1 month) Randomisation and allocation: not reported Blinding: no; randomisation was revealed to the surgeon before induction of anaesthesia Follow‐up: at 1, 3 and 6 months. 9 patients were lost to follow‐up and were not analysed and reported because they needed adenectomy or did not return for follow‐up Power calculation for sample size: yes, was calculated using operative time as a primary outcome. With a type I error of 0.05 and a power of 80%, a sample size of 30 women in each arm was required. No intention‐to‐treat analysis
Participants	90 women with a mean age of 41.9 in the TLH group, 43.4 in the LAVH group and 43.7 in the NDVH group Inclusion: benign pathology of uterus and not amenable to or failed medical therapy Exclusion: malignancy, PID, uterovaginal descent greater that first degree. Patients with contraindication for laparoscopy.
Interventions	TLH versus LAVH versus non‐descent VH (NDVH) TLH: 4 ports were made. A 10 mm umbilical port for laparoscope, 2 ports of 5 mm, 1 extra 10 mm port. All pedicles were coagulated and transected laparoscopically. Adnexa were preserved. The uterus was cut at the vault laparoscopically. Uterus was delivered vaginally. Vaginal cuff closure: the vault was sutured laparoscopically LAVH: the laparoscopic part included coagulation and transection of round ligament, ovarian ligament and medial end of tube followed by dissection of bladder peritoneum. The procedure was then completed vaginally: uterosacrale ligaments, cardinal ligaments and uterine vessels were ligated and transected. The uterus was extracted vaginally. Vaginal cuff sutured. AAGL LAVH classification: IB NDVH: incision was made in cervico‐vesical junction anteriorly. Bladder was pushed anteriorly and pouch of Douglas opened posteriorly. Uterosacral ligaments, Mackenrodt ligament, uterine vessels followed by round and ovarian ligament were clamped, transected. In cases of large uteri, bisection of the specimen or myomectomy was done. Vaginal cuff was sutured. Surgeons: all procedures were performed by the same surgeon. Experience not reported
Outcomes	Intra‐ and postoperative parameters Primary outcomes: total duration of surgery and blood loss Secondary outcomes: postoperative pain, febrile morbidity, infection, total duration of hospital stay, satisfaction (HRQOL and SF‐12) and sexual dysfunction (self developed questionnaire)
Notes	India All India institute, New Delhi Funding: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Randomisation was revealed to surgeon just before induction of anaesthesia. Blinding of patients or researchers not reported.
Incomplete outcome data (attrition bias) All outcomes	High risk	No dropouts. Loss to follow‐up reported (n = 9; i.e. 10%)
Selective reporting (reporting bias)	Low risk	Patients who also underwent adnexal removal were excluded to minimise bias
Other bias	Low risk	No other bias identified

Roy 2012.

Study characteristics
Methods	Single tertiary centre Duration: April 2008 to June 2010 (2 years, 1 month) Randomisation: computer‐based Allocation procedure: not reported Number of women randomised = 23, number of women analysed = 20. 3 dropouts: serum interleukin level could not be processed in 1 patient from each group; 1 patient had conversion to mini‐laparotomy Blinding: not reported Analysis by intention‐to‐treat: no; 1 conversion in the LAVH group was taken out of analysis and was not further reported Follow‐up: no loss to follow‐up Power calculation for sample size: to detect a difference of 1 standard deviation between interleukin level of the 2 groups of hysterectomy for a uterine size ≥ 12 weeks, with type 1 error of 0.01 and a power of 80%, calculated that 10 women needed to be operated in each group
Participants	20 women with a mean age of 41.6 years in the LAVH group and 43 years in the NDVH group Inclusion criteria: women with benign pathology of uterus who had estimated uterine weight between 300 g and 1500 g and were planned for hysterectomy Exclusion criteria: genital malignancy, acute pelvic inflammatory disease, utero‐vaginal descent greater than first degree and any contraindications for laparoscopy
Interventions	Laparoscopic‐assisted vaginal hysterectomy (LAVH) versus non‐descent vaginal hysterectomy (NDVH) LAVH: 4 ports were made. A 10 mm port was placed at umbilicus for laparoscope. 3 other ports were placed in the lowed abdomen. The laparoscopic part included coagulation and transection of round ligament and transection of bladder peritoneum. When preservation of adnexa was needed, the fallopian tube and ovarian ligament were coagulated and transected. In cases where salpingo‐oophorectomy was needed, the infundibulopelvic ligament was isolated, coagulated and transected. The procedure was completed vaginally. The anterior and posterior cul‐de‐sac were opened. The cardinal ligaments, uterosacral ligaments and the uterine vessels were ligated and transected. The uterus was extracted vaginally. Vaginal cuff was closed. AAGL LAVH classification: IB NDVH: incision was made in cervico‐vesical junction anteriorly. Bladder was pushed anteriorly and pouch of Douglas opened posteriorly. The uterosacral ligaments, cardinal ligaments, uterine vessels followed by round and ovarian ligaments were clamped, cut and ligated. After clamping uterine arteries, uterus was bisected and myomectomy done to reduce the bulk of the uterus. Vaginal cuff was closed. Surgeons: all procedures performed by the same surgeon. Experience not reported. Antibiotic and thrombo‐prophylaxis not specified
Outcomes	Primary: venous blood levels of IL‐6 preoperatively and 3, 24 and 72 hours after surgery Secondary: blood loss, operating time, postoperative analgesia requirement, hospital stay and morbidity
Notes	India All India Institute, New Delhi Funding: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation: computer‐based
Allocation concealment (selection bias)	Unclear risk	Allocation procedure not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	Dropouts: n = 3, i.e. 15%. No loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Since the study focused mainly on tissue trauma, 1 patient who underwent a conversion to mini‐laparotomy was excluded from the final analysis
Other bias	Unclear risk	Analysis by intention‐to‐treat: not reported

Sarlos 2012.

Study characteristics
Methods	Single‐centre Duration: 2008 to 2011 (3 years) Randomisation: the randomisation scheme was generated by using the website www.randomization.com Allocation concealment: not reported Blinding: patients could not be blinded because the robot surgery took place in another building Number of women: 100 patients randomised; 95 completed the study Follow‐up: loss to follow‐up not described, but 5 patients did not complete study Power calculation for sample size: not performed Analysis by intention‐to‐treat
Participants	95 patients with a mean age of 45.8 years in the conventional group and 46.3 years in the robot‐assisted group Inclusion criteria: indication for hysterectomy because of benign lesions if vaginal hysterectomy was expected to be difficult because of myomas or nulliparity. Uterus weight less than 500 g. Exclusion criteria: not reported
Interventions	Robot‐assisted TLH versus conventional TLH RA‐TLH: a 3‐armed daVinci standard surgical robot was used Conventional TLH: a 10 mm optical port and 3 5 mm working trocars were used Both procedures performed according the same standard operating procedure Vaginal cuff closure: the vault was sutured laparoscopically when the uterus was delivered vaginally. When vaginal morcellation took place in a robot assisted TLH the vault was closed vaginally. Antibiotic prophylaxis: cefazoline 2 g Surgeons: 2 senior gynaecologists experienced in laparoscopic surgery, performing at least 50 laparoscopic LH and 30 RH per year. The surgical team consisted of a console surgeon, a bedside assistant and a surgical nurse No conversions to laparotomy
Outcomes	Primary outcomes: surgical outcome (time to hospital discharge) and quality of life
Notes	Switzerland Cantonal Hospital, Aarau Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation scheme was generated by using the website www.randomization.com
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Patients could not be blinded because the robot surgery took place in another building
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No dropout. Follow‐up not described
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes predefined and reported as such
Other bias	Low risk	No other bias identified

Schütz 2002.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: August 1995 to December 1997 (2 years, 4 months) Randomisation: computer‐generated randomisation list Allocation concealment: concealment by telephone enquiry Blinding: no Number of women randomised = 48, number analysed = 48. No dropouts. Follow‐up: following discharge from hospital the women received a self administered questionnaire to evaluate their recuperation over a period of 12 months; 35 women (72.9%) answered the questionnaire, 20 of 28 (71.4%) in the LAVH group and 15 of 20 (75%) in the AH group Power calculation for sample size: yes
Participants	48 women with median age of 48 years Inclusion criteria: sonographically estimated uterine weight > 200 g and patient has no preference for either surgical technique Exclusion criteria: not stated
Interventions	AH versus LH LH arm: either type I or II procedure. Type I: the laparoscopic part included coagulation and transection of the round ligament and transection of the bladder peritoneum. If the adnexa was desired, the fallopian tube and the ovarian ligament were coagulated and transected. Where salpingo‐oophorectomy was needed, the infundibulo‐pelvic ligament was isolated, coagulated and transected following visualisation of the ureter. Type II: the uterine artery was identified at its origin when branching off the internal iliac artery. The identification was made coming from either the internal umbilical ligament or the pararectal fossa. Prior to coagulation of the uterine artery, the ureter was identified and pushed medially. After coagulation, it was left to the discretion of the surgeon to transect the uterine artery. The uterus was mobilised by pulling on the transected round ligaments and no intrauterine probes were applied for mobilisation of the uterus Surgeons: 71.4% operations performed by attending physician, 28.6% by resident assisted by physician AH arm: followed the standard extrafascial technique. A Balfour retractor was used and the skin incision was stapled. Surgeons: 40% performed by physician and 60% by resident assisted by physician
Outcomes	Primary outcome: length of stay in hospital Secondary outcomes: operating time, postoperative pain, blood loss and recovery time until return to full work activity
Notes	Germany Friedrich Schiller University, Jena Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list
Allocation concealment (selection bias)	Low risk	Telephone enquiry
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	No dropouts; loss to follow‐up: 75% and 78%, respectively, answered the questionnaire after 12 months (i.e. > 15% loss to follow‐up)
Selective reporting (reporting bias)	Low risk	No reporting bias identified
Other bias	Unclear risk	Surgeons' experience was not clear

Seracchioli 2002.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: January 1997 to January 2001 (4 years) Randomisation: computer‐generated randomisation unknown to the surgeons Allocation concealment: not mentioned Blinding: no Number of women randomised = 122, 122 analysed. No dropouts reported. Follow‐up: telephone interviews 2 months after discharge to determine the number of days before going back to normal activities. No loss to follow‐up Power calculation for sample size: no
Participants	122 women with a mean age of 46.3 (LH(a) group) and 47.3 (AH group) Inclusion criteria: eligible for AH due to a large uterus (> 14 weeks) caused by myomas. Uterine weight > 300 g, determined by a pelvic examination and transvaginal ultrasonography. Exclusion criteria: uterus projecting above the transverse umbilical line and with other pelvic pathologies (prolapse, pelvic floor relaxation, stress incontinence and adnexal masses). Medical conditions that require hospital monitoring, e.g. diabetes, heart disease, if they had undergone previous abdominal surgery requiring longitudinal laparotomy or contraindications to operative laparoscopy
Interventions	AH versus TLH TLH: 10 mm cannula placed in the umbilical site to introduce the laparoscope and camera. 2 5 mm suprapubic access routes were inserted lateral to deep inferior epigastric arteries. A third cannula was inserted between the umbilicus and xiphoid. Round ligaments, fallopian tubes and utero‐ovarian ligaments (or infundibulopelvic ligaments if the ovaries were to be removed) were coagulated and sectioned. Uterine peritoneal fold was opened with scissors, dissecting the bladder off the lower uterine segment and cervix. Incision of the fornix, extended laterally, stopping close to uterine vessels. Uterine pedicles skeletonised, coagulated and sectioned. Parametrial tissues were coagulated and sectioned, so the uterus is free to be removed vaginally. Vaginal cuff closure: vaginal vault was sutured vaginally with the cardinal‐uterosacral ligaments Antibiotic prophylaxis: ampicillin 2 g Surgeons: all surgical procedures were performed by the same investigators under GA. Experience not reported.
Outcomes	Operating time, laparo‐conversions, blood loss, haemoglobin drop, fever, transfusions, hospital stay and convalescence
Notes	Italy S Orsola Hospital, University of Bologna Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	Unclear risk	Allocation reported as "unknown to surgeons"
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Primary outcome not defined
Other bias	Low risk	No other bias identified

Sesti 2008a.

Study characteristics
Methods	Single‐centre study, 3 parallel‐groups Duration: May 2005 to September 2007 (2 years, 4 months) Randomisation: computer‐generated list Allocation concealment: serially numbered, opaque, sealed envelopes Blinding: patients were not blinded. Those performing the surgical procedures did not know which patients had been included in the study and those assessing the outcomes were blinded to the group assignment Number of women eligible 189, number of women randomised 150. There were no dropouts. Follow‐up: no loss to follow‐up Power calculation for sample size: yes, 36 patients in each group were necessary to detect a difference of more than 24 hours in discharge time with an alpha error level of 5% and a beta error of 80% Analysis was by intention‐to‐treat (no conversions)
Participants	50 women in the VH group (mean age 47.8 years) 50 women in the LAVH group (mean age 49.0 years) 50 women in the mini‐laparotomy (mini‐LPT) group (mean age 47.7 years) Inclusion criteria: symptomatic or rapidly growing myomas, age less than 55 years and uterine size greater than or equal to 12 weeks of gestation Exclusion criteria: nulliparous women, uterine size greater than or equal to 16 weeks, previous uterine surgery and suspicion of malignant gynaecological disease
Interventions	VH versus LAVH versus mini‐laparotomy (LPT) VH: as described by Dargent in 2004. If the uterine size did not allow easy exteriorisation, bisecting, coring, morcellation, enucleation of myomas or combinations of these volume‐reducing techniques were performed LAVH: dissection up to but not including uterine arteries plus anterior structures, and posterior culdotomy performed laparoscopically. The remainder of the procedure was done vaginally. AAGL LAVH classification: ID Mini‐LPT: performed using a 4 cm to 7 cm suprapubic incision. The subcutaneous fat and the abdominal fascia were transversely opened 2 cm above the skin incision. The abdominal muscle and the parietal peritoneum were longitudinally opened on the midline. Antibiotics: all patients received intraoperative prophylactic antibiotic therapy (ampicillin sodium/sulbactam sodium combination 2 g). Intravenous pain relief was given postoperatively. Surgeons: all procedures were performed by 2 equally skilled and experienced surgeons using identical techniques
Outcomes	Primary outcome: difference in hospital discharge time (measured in hours) among the 3 procedures Secondary outcomes: operating time, blood loss, paralytic ileus time, intraoperative complications, febrile morbidity, intensity of postoperative pain and early postoperative complications
Notes	Italy Tor Vergata University Hospital, Rome Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Those assessing the outcomes were blinded to the group assignment; patients were not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes (pre)defined and reported accordingly
Other bias	Low risk	Procedures were performed by 2 equally skilled and experienced surgeons using identical techniques

Sesti 2008b.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: April 2003 to June 2005 (2 years, 2 months) Randomisation: numbered, sealed, opaque envelopes based on a computer‐generated list Blinding: those who performed surgical procedures did not know which patients undergoing surgery had been included in the study. Those assessing the outcomes were blinded to the group assignments Number of women eligible = 89; 9 women refused to participate and 80 patients were included (40 in each group). There were no conversions or dropouts. Follow‐up: women were followed up until 30 days after surgery. No loss to follow‐up. Power calculation for sample size: yes, at least 26 patients in each group were necessary to detect a difference of more than 24 hours in discharge time with a significance level of 0.05% and a power of 80%
Participants	80 women with a mean age of 49 years in the VH group and 48 years in the LAVH group Inclusion criteria: symptomatic or rapidly growing myomas, age < 55 years, uterine size at least 12 weeks gestation Exclusion criteria: nulliparous women, uterine size greater than 16 weeks gestation, previous uterine surgery, suspicion of malignant gynaecological disease
Interventions	VH versus LAVH VH: as described by Dargent in 2004. If the uterine size did not allow easy exteriorisation, bisecting, coring, morcellation, enucleation of myomas or combinations of these volume‐reducing techniques were performed LAVH: dissection up to but not including uterine arteries plus anterior structures and posterior culdotomy performed laparoscopically AAGL LAVH classification: ID Antibiotics: patients in both groups received prophylactic antibiotic therapy by an ampicillin sodium/sulbactam sodium combination Type of anaesthesia not mentioned for VH Surgeons: all procedures performed by the same 2 surgeons using the same technique. Surgeon experience not mentioned.
Outcomes	Primary outcomes: discharge time as measured in hours after surgery. The patients were discharged from the hospital when they were tolerant of a normal diet, able to dress themselves, fully mobile, apyrexial and not requiring analgesics Secondary outcomes: differences in operation time, blood loss, paralytic ileus time, febrile morbidity (body temperature 38 °C in 2 consecutive measurements 4 hours apart), intensity of pain, early postoperative complications (any unfavourable episode occurring within 30 days after surgery requiring readmission, blood transfusion or repeat surgery)
Notes	Italy Tor Vergata University Hospital Research funds by the Italian Ministry of Education
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list
Allocation concealment (selection bias)	Low risk	Numbered, sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Those assessing the outcomes were blinded to the group assignments; patients not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes (pre)defined and accordingly reported
Other bias	Low risk	No other bias identified

Sesti 2014b.

Study characteristics
Methods	Single‐centre randomised controlled trial Duration: 3 years, 5 months Randomisation: computer‐generated list using serially numbered, opaque, sealed envelopes; TLH vs LAVH vs VH Allocation concealment: the sequence was concealed until interventions were assigned Blinding: N/A, but those who performed surgical procedures did not know which operating patients had been included in the study. Those assessing the outcomes were blinded to the group assignments. Number of women: 108 patients; 36 in each of 3 arms Follow‐up: 30 days Power calculation for sample size: for detecting a difference of more than 24 hours in discharge time with an alpha error level of 5 % and a beta error of 80 %, it has been estimated that at least 36 patients in each group would have been necessary
Participants	Mean age of women was 49.7 in the TLH group, 49 in the VH group and 48.2 in the LAVH group Inclusion criteria: 1) presence of symptomatic or rapidly growing myomas, 2) age < 55 years, 3) uterine size ≥ 12 weeks gestation (12 cm long) Exclusion criteria: 1) nulliparous women, 2) uterine size ≥ 16 weeks gestation (16 cm long), 3) previous uterine surgery, 4) suspect malignant gynaecological disease
Interventions	TLH vs LAVH vs VH LAVH procedure: dissection up to but not including uterine arteries plus anterior structures, and posterior culdotomy performed laparoscopically. The remainder of the procedure was done vaginally. A uterine manipulator was used. Laparoscopy was performed with a 10 mm principal trocar and 2 ancillary 5 mm trocars. AAGL LAVH classification: ID TLH procedure: same as LAVH with the following modifications. After incising the posterior peritoneal leaf of the broad ligament, subsequent steps were performed laparoscopically. The uterus was removed vaginally. When the considerable uterine size demanded, laparoscopic morcellation was performed. TLH vaginal cuff closure: not described Vaginal hysterectomy: as described by Dargent. If the uterine size did not allow easy exteriorisation, bisecting, coring, morcellation, enucleation of myomas or combinations of these volume‐reducing techniques were performed Surgeons: All procedures were performed by the same equally skilled and experienced surgeons (more than 100 TLH, LAVH or VH surgeries).
Outcomes	The primary outcome of the trial was the comparison between the three procedures in terms of discharge time measured in hours after the end of surgery. The secondary outcome measures were differences in operating time, blood loss, paralytic ileus time, intraoperative complications, intensity of postoperative pain, febrile morbidity (body temperature ≥ 38 °C in two consecutive measurements ≥ 4 h apart), early postoperative complications (any unfavourable episode occurring within 30 days from surgery requiring re‐admission, blood transfusion, repeat surgery).
Notes	Took place in Rome, Italy
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list
Allocation concealment (selection bias)	Unclear risk	It was mentioned that the sequence was concealed until interventions were assigned
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Patients and surgeons could not be blinded to the procedure. However, the authors made an attempt to mitigate this effect by blinding outcome assessors and by not revealing to the surgeons which patients were study participants.
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were no dropouts or losses to follow‐up
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes are defined and reported
Other bias	Low risk	Surgeon experience is reported. Details of the procedure are reported. Dates of enrolment are reported. A power calculation was performed.

Silva Filho 2006.

Study characteristics
Methods	Parallel‐group design Duration: July 2004 to January 2005 (6 months) Randomisation: not reported Blinding: not reported Number of womenrandomised: 60. There were no dropouts. There were no conversions to AH in the VH group. Follow‐up: women were followed up until 1 month after surgery. The return rate of the questionnaires at 1 month was 100%. Power calculation for sample size: no Analysis was by intention‐to‐treat
Participants	60 women; mean age 45 years in both groups Inclusion criteria: women with myoma and uterine size < 300 cm3 Exclusion criteria: uterine prolapse, need for associated procedures, suspicion of extrauterine disease
Interventions	VH and TAH Procedures were performed according to the modified Richardson's and Heaney's technique. Bisection and morcellation if needed in VH Antibiotics: both groups received prophylactic antibiotic treatment (cefalotin 1 g IV) and anticoagulant therapy Epidural anaesthesia for both VH and TAH Surgeon experience: surgeons reported as experienced in both procedures
Outcomes	Primary outcome: quality of life (questionnaire SF‐36) Secondary outcomes: operative time; conversions to AH; hospital stay
Notes	Brazil It is unclear from which hospital(s) the women were recruited Funding not reported The subscales and score ranges of the questionnaire SF‐36 are not in agreement with the international standard
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding of patients not reported. The interviewer at 1 month after surgery was blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Low risk	No reporting bias identified
Other bias	Unclear risk	The subscales and score ranges of the questionnaire SF‐36 were not in agreement with the international standard

Song 2013.

Study characteristics
Methods	Single‐centre Duration: January 2010 to January 2011 (12 months) Randomisation: patients were randomly assigned 1:1 with the use of a computer‐generated schedule to undergo LESS LAVH or multi‐port LAVH. Randomisation was performed in permuted blocks of 4 with random variation of the blocking number. Allocation procedure: a research nurse prepared all numbered, opaque, sealed envelopes Blinding: not reported Number of women: 40 women randomised, 39 women analysed. 1 SP‐LH procedure converted. Follow‐up: 1 woman assigned to multi‐port was lost to follow‐up Power calculation for sample size: yes, on the basis of the difference in primary outcome. Assuming a standard deviation of 2 points for the BIS or CS score, allowing 5% dropout rate, they estimated that 20 patients would be needed per group.
Participants	39 women with a mean age of 44.6 and 43.5 respectively Inclusion criteria: patients who had an indication for hysterectomy, no evidence of gynaecologic malignancy, appropriate medical status for laparoscopic surgery (ASA 1 or 2) Exclusion criteria: age ≤ 18 years, uterine size > 20 weeks, recent diagnosis of cancer, inability to understand and provide written informed consent
Interventions	Single port‐LH versus conventional multi‐port LAVH Multi‐port LAVH: after the primary 12 mm trocar was placed at the umbilicus, a 5 mm trocar was placed in each lower quadrant, lateral to the inferior epigastric artery. The bladder peritoneum was not dissected during the laparoscopic phase. The vaginal vault was closed vaginally. AAGL LAVH classification: 1A Surgeons: all procedures by a single surgeon with experience of more than 500 LH and 200 SP‐LH
Outcomes	Primary outcomes: cosmetic satisfaction 1, 4 and 24 weeks after surgery Secondary outcomes: operative time, perioperative complications and postoperative hospital stay
Notes	Korea Samsung Medical Center, Seoul Supported by grant CRS 110‐09‐1 from Samsung Medical Center
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomly assigned 1:1 with the use of a computer‐generated schedule to undergo LESS LAVH or multi‐port LAVH. Randomisation was performed in permuted blocks of 4 with random variation of the blocking number
Allocation concealment (selection bias)	Low risk	A research nurse prepared all numbered, opaque, sealed envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up/conversions reported (< 5%)
Selective reporting (reporting bias)	Low risk	No reporting bias
Other bias	Low risk	No other bias identified

Soriano 2001.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: January 1999 to December 1999 (1 year) Randomisation: pre‐determined computer‐generated randomisation code Blinding: no Number of women randomised: 80, number analysed = 80. No reported dropouts. Follow‐up: until women were discharged from hospital Power calculation to estimate sample size: yes. Assumed that the incidence of complications in patients undergoing LH(a) is 10% and there will be an increase of complication rate to 40%, with alpha (type I error) of 0.05 and beta (type II error) of 0.2. It was planned to recruit at least 35 women to each arm.
Participants	80 women with a mean age of 49 years Inclusion criteria: women referred for hysterectomy due to benign pathology. Uterine size larger than 280 g and one or more of the following: previous pelvic surgery, history of pelvic inflammatory disease, moderate or severe endometriosis, concomitant adnexal masses or indication for adnexectomy Exclusion criteria: suspicious adnexal mass, anaesthetic contra‐indications for laparoscopic surgery. Women with contra‐indications to acetaminophen, or to nonsteroidal anti‐inflammatory drugs and those whose pain evaluation was judged unreliable due to neurological disease, or treatment by steroids, NSAIDs or opioids prior to surgery
Interventions	VH versus LAVH LAVH: after induction of pneumoperitoneum and insertion of the video laparoscope, 3 suprapubic trocars were introduced for the ancillary instruments. The pelvis and the upper abdomen were evaluated and endo metric lesions, adhesion or ovarian cysts, when present, were treated. When the ovaries were to be conserved, bipolar forceps and scissors were used to resect the round ligament and the uteroovarian ligaments with the fallopian tubes. For adnexectomy, bipolar forceps and scissors were used to resect the round and infundibulopelvic ligaments, mesosalpinx and mesovarium. The laparoscopy included opening the bladder flap and bladder dissection, coagulating and transecting the uterosacral ligaments, base of cardinal ligaments and uterine vessels. Laparoscopic haemostasis was achieved using exclusively bipolar electrocoagulation. The vaginal phases included only circular incision of the vagina and wedge morcellation, coring or bivalving was performed. Peritoneal closure and closure of the vaginal vault concluded the vaginal phase. AAGL LAVH classification: IVB VH arm: performed using the modified Heaney procedure. When necessary, wedge morcellation, coring or bivalving was performed. Surgeon experience: not reported Prophylactic antibiotic: cefazoline 2 g IV and low molecular heparin the evening before the operation. Intravenous pain relief was given postoperatively.
Outcomes	Uterine weight; operative time; haemoglobin drop; postoperative complications; blood loss; pain relief and hospital stay
Notes	France Hôpital Hôtel‐Dieu, Paris Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation code
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts; no loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Outcomes not clearly defined; insufficient information available
Other bias	Low risk	Surgeons' experience not specified. No other possible bias identified

Summitt 1992.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: June 1991 to February 1992 (9 months) Randomisation: computer‐generated randomisation numbers Blinding: no Number of women randomised = 56, number analysed = 56. One operation was unsuccessful therefore for certain outcomes only 55 were analysed. Follow‐up: postoperative follow‐up consisted of a telephone call by the attending surgeon on the evening of surgery and the first 2 postoperative days. Patients were then seen 1 and 6 weeks postoperatively in the outpatient clinic. Power calculation for sample size: not reported Analysis not by intention‐to‐treat (conversion excluded from analysis)
Participants	56 women with a mean age of 38 years Inclusion criteria: 1) age 18 to 65 years; 2) no significant medical illness that required prolonged postoperative monitoring or care; 3) a telephone in working order; 4) a support person who could assist the patient for the first 48 hours after surgery and 5) an understanding of all postoperative instructions Criteria for VH: 1) uterine size no larger than 16 gestational weeks; 2) the presence of uterine mobility; 3) a pubic arch of at least 90 degrees. Factors that did not influence the decision to proceed vaginally include: 1) a preoperative diagnosis of pelvic pain; 2) the need for oophorectomy, or 3) a history of previous pelvic surgery Exclusion criteria: 1) a concomitant anterior or posterior colporrhaphy was required; 2) cervical conisation was performed within the previous 48 hours; and 3) additional antibiotic prophylaxis was required for valvular heart disease. They were also excluded if they had absolute contraindications to laparoscopy, such as 1) any condition that could not tolerate anaesthesia, 2) severe bleeding disorder, 3) acute peritonitis of the upper abdomen and uterine myomata or 4) a pelvic mass larger than 16 gestational weeks in size
Interventions	VH versus LAVH LAVH arm: 3 x 12 mm trocars were used, one placed infra‐umbilically and one placed in each lower quadrant approximately 6 cm to 8 cm above the pubic rami, lateral to the inferior epigastric arteries. A Hulka tenaculum was used to manipulate the uterus. The bladder flap was developed by incising the vesicouterine fold of peritoneum and dissecting the bladder below the cervix. The ureters were then identified and mobilised using linear incisions in the medial leaf of the broad ligament, midway between the uterosacral ligaments and infundibulopelvic vessels The Multifire EndoGIA disposable surgical stapler was used to staple‐ligate and cut all uterine pedicles, each consisting of the round ligament, fallopian tubes and utero‐ovarian ligament, were cut. If the ovaries were to be removed, the stapler was instead placed outside the tube and ovary, encompassing the infundibulopelvic ligament. The uterine arteries were next staple‐ligated and cut bilaterally. If possible, the stapling device was also used to ligate and cut the cardinal ligaments. Otherwise, stapling of uterine pedicles ended and the anterior vaginal fornix was entered with unipolar cautery, incising over a moistened sponge distending the anterior vagina. The remainder of the hysterectomy was completed vaginally Surgeons: performed by a team of 3 surgeons (2 attending faculty and a senior gynaecology resident) VH arm: anaesthesiologist's choice of general or regional anaesthesia. A modified Heaney technique was performed using O‐coated polyglycolic acid suture for all pedicles. The vaginal cuff was closed in all cases. Surgeons: performed by a gynaecology resident with attending faculty member All received pre‐operative antibiotic prophylaxis (cefazolin 2 g) intravenously. If allergic to penicillin, 200 mg dose of doxycycline intravenously was used.
Outcomes	Operating time, blood loss, anaesthesia time, intraoperative complications, febrile morbidity, pain relief and costs
Notes	USA Gynecology Clinic, University of Tennessee, Memphis Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated numbers
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No dropouts, loss to follow‐up not reported
Selective reporting (reporting bias)	Unclear risk	Primary outcome not defined
Other bias	Unclear risk	No intention‐to‐treat analysis, no power calculation. Procedures performed by different group of surgeons

Summitt 1998.

Study characteristics
Methods	Multicentre study (n = 3), parallel‐group design Duration: not reported Randomisation: computer‐generated randomisation list Allocation procedure: each surgical assignment placed in consecutive sealed envelopes and opened by an independent person (study secretary) Blinding: no Number of women randomised = 67, number analysed = 65; 2 women who were randomised refused their assigned procedure and they were removed from the study and their random numbers discarded Follow‐up: 2 and 6 weeks postoperatively in the outpatient office. No loss to follow‐up. Power calculation to estimate sample size: not reported Analysis said to be by intention‐to‐treat, but 2 randomised women were not analysed
Participants	65 women with a mean age of 38.3 (LH(a) group) and 41.5 (AH group) Inclusion criteria: scheduled for AH for benign diseases. Indications for AH: 1) documented visual diagnosis of pelvic endometriosis; 2) documented pelvic adhesions; 3) 3 or more previous laparotomies; 4) uterine leiomyomata 12 to 18 gestational weeks in size; 5) previous tuboovarian abscess or 2 documented episodes of pelvic inflammatory disease requiring IV antibiotic therapy; 6) adnexal mass in the presence of an indication for hysterectomy; and 7) indicated hysterectomy with lack of mobility and unfavourable vaginal introitus. The following inclusion criteria were met: 1) age at least 18 years, 2) a working telephone in the home, 3) an available support person in the home for 48 hours after surgery, and 4) an understanding of the postoperative instructions Exclusion criteria: concomitant colporrhaphy, urethropexy, vaginal vault suspension or a non‐gynaecologic major operation required. Medical conditions requiring in‐hospital monitoring or if they had known cervical or endometrial cancer. Candidates were also excluded if they had absolute contraindications to operative laparoscopy, including: 1) uterine leiomyomas or pelvic masses greater than 18 gestational weeks in size, 2) conditions making them intolerant to anaesthesia, 3) severe bleeding disorders, 4) acute periodontitis of the upper abdomen with severe distension, or 5) a midline abdominal hernia
Interventions	AH versus LAVH LAVH: 3 x 12 mm trocars were used, one placed infra umbilically and one placed in each lower quadrant approximately 6 cm to 8 cm above the pubic rami, lateral to the inferior epigastric arteries. A Hulka tenaculum was used to manipulate the uterus. The bladder flap was developed by incising the vesicouterine fold of peritoneum and dissecting the bladder below the cervix. The ureters were then identified and mobilised using linear incisions in the medial leaf of the broad ligament, midway between the uterosacral ligaments and infundibulopelvic vessels The Multifire EndoGIA disposable surgical stapler was used to staple‐ligate and cut all uterine pedicles, each consisting of the round ligament, fallopian tubes and utero‐ovarian ligament, were cut. If the ovaries were to be removed, the stapler was instead placed outside the tube and ovary, encompassing the infundibulopelvic ligament. The uterine arteries were next staple‐ligated and cut bilaterally. If possible, the stapling device was also used to ligate and cut the cardinal ligaments. Otherwise, stapling of uterine pedicles ended and the anterior vaginal fornix was entered with unipolar cautery, incising over a moistened sponge distending the anterior vagina. The remainder of the hysterectomy was completed vaginally AH arm: modified Richardson technique Surgeon experience: not reported All received pre‐operative antibiotic prophylaxis (cefazolin 2 g) intravenously. If allergic to penicillin, 200 mg dose of doxycycline intravenously was used.
Outcomes	Operating time; blood loss; intraoperative and postoperative complications; hospital stay; febrile morbidity; requirement for analgesia; recovery time; conversion to abdominal hysterectomy and costs
Notes	USA University of Tennessee, Memphis; Bowman Gray School of Medicine, Winston‐Salem, North Carolina; University of North Carolina, Chapel Hill Funding: US Surgical Corporation, Norwalk, Connecticut USA
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	2 women refused assigned procedure and were excluded from analysis No loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	Primary outcome not defined
Other bias	Unclear risk	Analysis not according to intention‐to‐treat Surgeons' experience not reported Funding from pharmaceutical or surgical instrumentation company

Tormena 2017.

Study characteristics
Methods	Duration: 1 year and 3 months Randomisation: yes (using the Random Password Generator Bitmill Inc (Calgary, Canada)) Allocation concealment: not mentioned Blinding: N/A Number of women: 42 Follow‐up: not specifically mentioned, although the following statement is made: "12 months after the surgeries, we identified three cases of umbilical hernias in the SP‐TLH group." Power calculation for sample size: not reported
Participants	Mean age: 46.71 in the multi‐port TLH group, 47.58 in the single port TLH group Inclusion criteria: not specifically mentioned (patients with benign gynaecological diseases who were scheduled for hysterectomies at the São Paulo University Medical School Hospital.) Exclusion criteria: patients with coagulation disorders, those who used any anti‐inflammatory agents within the previous 3 months, those with suspected uterine cancer, those with endometriosis or pelvic inflammatory disease, those with contraindications for general anaesthesia, those with genital prolapse or those with uterine volumes greater than 600 cm3
Interventions	Single‐port TLH versus multi‐port TLH SP‐TLH: Initially, a 2.5‐cm trans‐umbilical longitudinal incision was made until the aponeurosis was reached; this incision was opened and fixed with stitches in both sides. Next, the peritoneum was opened, and a disposable three‐channel single‐port device was inserted, i.e., either the Triport Access System (Olympus, Center Valley, PA) or the Single Site Laparoscopy (SSL) Access System (Ethicon Endo‐Surgery, Somerville, NJ, USA). A 30 degree 5 mm obese telescope associated with conventional rigid laparoscopic instruments, including monopolar and bipolar were used. The utero‐ovarian ligament, fallopian tube pedicles and the round ligaments were coagulated and divided with ultracision scissors. The vesicouterine peritoneal fold and bladder were mobilised off of the uterus and upper vagina until the anterior vagina was identified. The broad ligament peritoneum was divided, and the uterine artery was coagulated and divided with bipolar and ultracision scissors. The cardinal and uterosacral ligaments, one for each side, were divided. The vagina was entered posteriorly near the cervicovaginal junction. A 4 cm diameter plastic vaginal delineator was placed in the vagina to circumferentially outline the cervical junction and prevent the loss of the pneumoperitoneum. Monopolar forceps were used to complete the circumferential culdotomy. Multi‐port TLH: 3 laparoscopic puncture sites, including the umbilicus, were used, i.e. 11 mm umbilical, 5 mm right and 5 mm left lower quadrant sites. A 10 mm telescope associated with conventional rigid laparoscopic instruments, including monopolar and bipolar forceps and Ultracision (Ethicon Endo‐ Surgery, Somerville, NJ, USA) were used. The hysterectomies were also performed as type IV‐E laparoscopic hysterectomies. Vaginal cuff closure was performed via the laparoscopic approach in all patients. Vaginal cuff closure: in the multi‐port group there were 14 cuffs closed vaginally and 5 closed laparoscopically with extracorporeal knot ties. In the single port group all cuffs were closed laparoscopically. Surgeons: not described
Outcomes	Primary outcomes: inflammatory markers (serum levels of CRP, IL‐6 and VEGF) Secondary outcomes: operative time, haemoglobin change, complications, postoperative pain, vaginal vault prolapse, umbilical hernias
Notes	São Paulo University Medical School Hospital Funding: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation was done using the Random Password Generator Bitmill® Inc (Calgary, Canada). There is some debate about whether these types of randomisation tools are accurate enough for RCTs.
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Not reported/performed
Incomplete outcome data (attrition bias) All outcomes	High risk	In the SP‐TLH group: “We inserted two additional suprapubic 5‐mm trocars to safely complete the procedure in one patient with extensive pelvic adhesions who were initially scheduled to SP‐TLH. This patient was excluded from the statistical analysis.” When following the rules on intention‐to‐treat, this patient should have been included and analysed in the SP‐TLH group Furthermore, one other patient in the same group did not return in the 6th POD visit, and she was also excluded from analysis
Selective reporting (reporting bias)	Unclear risk	Unclear primary vs secondary outcomes, so difficult to determine if there was reporting bias.
Other bias	Unclear risk	There was no power calculation reported. Additionally, surgeon experience was not reported. There is a description of the procedures and they appear standardised.

Tsai 2003.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: August 1997 to March 1999 (1 year, 6 months) Randomisation: computer‐generated random number sequence Allocation procedure: not reported Blinding: no Number of women randomised = 200, number analysed = 200 Follow‐up: duration not specified Not analysed on intention‐to‐treat basis ‐ 2 LAVHs converted to AH analysed as AH No power calculation for sample size reported
Participants	200 women with a mean age of 46.9 years (AH) and 46.7 years (LAVH) Inclusion criteria: good mobility of an enlarged uterus on bimanual pelvic examination Exclusion criteria: upper uterine margin higher than midpoint between symphysis pubis and umbilicus; pre‐existing cardiopulmonary dysfunction or poorly controlled systemic disease; cervical malignancy on colposcopy; indication for conventional VH
Interventions	AH versus LAVH AH technique: not specified LAVH: under GA. Uterine manipulator applied and pneumoperitoneum established. 2 trocar puncture sites, 12 mm umbilically and 2 mm right lower quadrant. 2 mm minilaparoscope allowed inspection and treatment of endometriosis lesions or adhesions through umbilical port. Multifire EndoGIA stapler resection of round and utero‐ovarian ligaments (or bipolar forceps applied to round ligaments if large myoma present). Vaginal phase included insertion of 10 mm laparoscope after division of the vesicouterine fold and peritoneal entry (the LETS technique). Then standard VH technique, including clamping, transection and suture ligation of uterosacral, cardinal and uterine pedicles, followed by peritoneal closure, then laparoscopic re‐evaluation and lavage after haemostasis if necessary. Antibiotic and thrombo‐prophylaxis not specified AAGL LAVH classification: AAGL class II Surgeons' experience: 2 attending doctors performed all hysterectomies, each with an experience of more than 50 laparoscopic procedures
Outcomes	Operating time; complications; duration of hospital stay
Notes	Taiwan University and municipal hospital in Kaohsuing Funding not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No dropouts, loss to follow‐up unclear. Follow‐up period not specified
Selective reporting (reporting bias)	Unclear risk	Primary outcome not defined
Other bias	High risk	Analysis not according to intention‐to‐treat (with 2 conversions from LH to AH). No power calculation reported. Surgeons' experience not reported. AH technique not reported

Wakhloo 2015.

Study characteristics
Methods	Duration: 1 year Randomisation: only mentioned that 100 patients with various indications for hysterectomy were divided in 2 groups randomly containing 50 patients each Allocation concealment: not mentioned Blinding: N/A Number of women: 50 in the LH group and 50 in the AH group Follow‐up: 6 weeks Power calculation for sample size: not performed
Participants	Inclusion criteria: “various indications for hysterectomy” Exclusion criteria: not mentioned Mean age in the LH group was 44.46, mean age in the AH group was 45.24
Interventions	LH versus AH Surgical technique: not described Surgeon experience: "As the surgeries were done in a teaching hospital allowing the surgeons in learning curve and residents to observe, assist and perform the laparoscopic procedures, the operative time was prolonged to some extent in laparoscopic cases.”
Outcomes	Time of surgery (in minutes); need for blood transfusion (intraoperative or postoperatively); intraoperative complications (ureteric injury, bladder injury, bowel injury, haemorrhage); postoperative complications (fever, wound infection, urinary tract infection); haemoglobin drop (difference in per‐operative and postoperative Hb); time to unaided ambulation (in days) and duration of hospital stay (in days). Furthermore, at each visit patient was assessed by clinical examination and asked about her recovery to normal household functions and sexual activity at the end of 6 weeks.
Notes	Reports a high number of bladder (2/50) and ureteric (2/50) injuries in the LH group The study took place in India. It is unclear whether it was a single or multicentre study.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The authors do not describe the method of randomisation
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	High risk	Not reported/performed
Incomplete outcome data (attrition bias) All outcomes	High risk	They do not report on dropouts, loss to follow‐up or conversions. Outcomes are reported in percentages, making it impossible to determine these numbers or whether they performed per protocol or intention‐to‐treat analysis.
Selective reporting (reporting bias)	High risk	No pre‐defined primary or secondary outcomes. The authors mention that at each visit patients were asked about their recovery towards household functions and sexual activity. However, they do not mention this outcome in the results section, nor in any table or the discussion.
Other bias	High risk	They do not describe the inclusion or exclusion criteria for the study in any detail. They did not perform a power calculation, report on surgeon experience or describe the surgical technique in any detail.

Yuen 1998.

Study characteristics
Methods	Single‐centre study, parallel‐group design Duration: January 1996 to June 1996 (6 months) Randomisation: computer‐generated sequence of random numbers Blinding: no Number of women randomised = 50, number analysed = 44; 4 declined the operation Follow‐up: until discharge from hospital; 2 refused to participate postoperatively No power calculation for sample size Analysis by intention‐to‐treat was reported
Participants	44 women with a median age of 44 (LAVH group) and 43 (AH group) Inclusion criteria: no major medical diseases requiring hysterectomy for benign disorders Exclusion criteria: suitable for VH or a uterus larger than 16 weeks' gravid size
Interventions	AH versus LAVH LAVH arm: performed with the use of 3 ports and bipolar desiccation for haemostasis. The laparoscopic part of the operation stopped after securing the uterine arteries, and the remainder of the operation was performed vaginally. AAGL LAVH classification: IIB AH arm: performed in the standard manner through a Pfannenstiel or lower midline incision Surgeon experience: not reported
Outcomes	Operation time; blood loss; postoperative stay and postoperative complications
Notes	Hong Kong Chinese University Funding: direct grant for research from the Chinese University of Hong Kong
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	4 dropouts were not analysed (4 declined the operation) and 2 were lost to follow‐up (refused to participate postoperatively). This is 5% to 10% of the sample
Selective reporting (reporting bias)	Unclear risk	Primary outcome not defined. Dropouts were not analysed
Other bias	Low risk	No other bias identified

Zhu 2009.

Study characteristics
Methods	Single‐centre Duration: 2004 to 2007 (3 years) Randomisation: not reported Allocation concealment: not reported Blinding: not reported Number of women: 101 women were randomised to 3 groups (34 LAVH, 35 TVH, 32 TAH). Dropouts not reported. Follow‐up: duration not specified Power calculation for sample size: not reported
Participants	69 women Inclusion criteria: patients of reproductive age and who had delivered at least 1 child. No adnexal disease; no gynaecological surgery history.
Interventions	TAH versus LAVH versus TVH TAH: performed utilising a standard technique LAVH: performed in a modified lithotomy position using a video‐monitor to record the laparoscopic part of the operation. A 10 mm scope was inserted subumbilically. Second and third entries were made suprapubically and on both sides. Round ligaments, tubes and utero‐ovarian ligaments had diathermy and were cut. In some cases the adnexa were also removed and others were to be preserved. The uterovesical fold of the peritoneum was divided by scissors. The uterine artery and the partial cardinal and uterosacral ligament had diathermy and were cut. The cervix was circumcised and the pouch of Douglas opened to allow ligation and division of the partial cardinal and uterosacral ligament, as in a traditional vaginal hysterectomy. AAGL LAVH classification: IIIC Surgeons: 2 senior gynaecologists performed all operations
Outcomes	Operation time, blood loss, pain score (VAS), bowel recovery time, fever, postoperative morbidity, hospital stay
Notes	China Peking Union Medical College Hospital, Beijing Funding: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	High risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Dropout not mentioned. From the tables it seems that there was no loss to follow‐up, but the follow‐up procedure was not specified
Selective reporting (reporting bias)	Unclear risk	Primary and secondary outcomes not defined
Other bias	High risk	Procedures not really comparable as in 2 of the 3 groups salpingo‐oophorectomy was also performed Pain score results must be interpreted with caution as different analgesics were used during the operation and postoperatively

AAGL: American Association of Gynecologic Laparoscopists
AH: abdominal hysterectomy
aLH: laparoscopic cases in the abdominal arm of the eVALuate trial
ASA: American Society of Anaesthesiologists
BDI: Beck Depression Inventory
BIS: Body Image Scale
BMI: body mass index
BSO: bilateral oophorectomy
cLH: conventional laparoscopic hysterectomy
CRP: C‐reactive protein
CS: Cosmetic Scale
DVT: deep vein thrombosis
EBVS: electrosurgical bipolar vessel sealing (device)
GA: general anaesthesia
GIA: not an abbreviation; refers to a registered trademark (stapler device)
HRQOL: health‐related quality of life
HRT: hormone replacement therapy
ICIQ‐FLUTS: International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms
ICIQ‐VS: International Consultation on Incontinence Questionnaire Vaginal Symptoms
IL‐6: interleukin 6
ITU: intensive therapy unit
IV: intravenous
LAVH: laparoscopic‐assisted vaginal hysterectomy
LAVHO: laparoscopy‐assisted vaginal hysterectomy with bilateral oophorectomy
LESS: laparo‐endoscopic single site surgery
LH(a): hysterectomy where the procedure is done laparoscopically up to and including the uterine vessels and the remaining part vaginally
NDVH: non‐descent vaginal hysterectomy
NRS: numerical rating scale
NSAID: nonsteroidal anti‐inflammatory drug
PCS: patient‐controlled analgesia
PGWB: Psychological General Well Being
PID: pelvic inflammatory disease
POP‐Q: Pelvic Organ Prolapse Quantification System
RALH: robot‐assisted laparoscopic hysterectomy
SD: standard deviation
SP: single‐port
STAI: State‐Trait Anxiety Inventory
TAH: total abdominal hysterectomy
TVH: total vaginal hysterectomy
TLH: total laparoscopic hysterectomy
VAS: visual analogue scale
VE: vaginal examination
VEGF: vascular endothelial growth factor
VH: vaginal hysterectomy
VHO: vaginal hysterectomy with bilateral oophorectomy
V‐NOTES: vaginal natural orifice hysterectomy
vLH: laparoscopic cases in the vaginal arm of the eVALuate trial
WHO: World Health Organization
WHQ: Women’s Health Questionnaire

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Aka 2004	Randomised trial comparing AH without colporrhaphy versus VH with colporrhaphy (n = 30). The complication profile for hysterectomy with colporrhaphy is different to hysterectomy without colporrhaphy. Inclusion of this trial and pooling for meta‐analysis would introduce undue clinical heterogeneity. Operation time was longer and hospital stay shorter in VH with colporrhaphy, compared with AH
Apoola 1998	Non‐randomised comparison of VH and AH for women with moderately enlarged uterus. Women undergoing VH had less blood loss, a smaller haemoglobin drop and a shorter hospital stay
Atabekoglu 2004	Randomised trial of LAVH versus AH (n = 46), but no intention‐to‐treat analysis. Authors did not measure any of our pre‐specified outcomes, focusing on tissue trauma (laboratory findings). There was one conversion to laparotomy in the laparoscopy group and a bladder lesions and a thrombophlebitis in the AH group. These patients were excluded from analysis. Lower CRP and CPK were found after LAVH
Balakrishnan 2016	Excluded because the study was not really randomised: alternately allocated to vaginal and abdominal groups
Beguinot 2020	In this trial the intervention was total laparoscopic hysterectomy using 3 mm instruments versus 5 mm (conventional) instruments; the procedure in both arms was the same. In the current update we have decided that this is not really another route of hysterectomy. Because of this we had to exclude the study.
Cardone 2010	Although presented as a randomised study, this was a comparison between a first sample of 100 patients treated with hysterectomy by laparotomy and a second sample of 100 patients treated with laparoscopic hysterectomy
Celik 2008	There was not sufficient information available to decide that this was a randomised controlled study. Although in the discussion it was mentioned that this was a randomised study, this could not be confirmed in the description of the design of the study
Chapron 1999	This study was not a randomised controlled trial. Study assessed hysterectomy techniques and the rate of total laparoscopic hysterectomy (TLH)
Chen 2021	This reference is an abstract of an oral presentation
Cucinella 2000	Women included in another publication on the same outcome measures
Davies 1998	There was not sufficient information available to decide that this was a randomised controlled trial. No further data provided by author after request
Demir 2008	Randomised trial of LH(a) (n = 15) versus TLH (n = 15) versus AH (n = 15) mainly focusing on tissue trauma by measuring IL‐6 and CRP. Lower values for both tissue trauma parameters were observed in LH(a) and TLH compared to AH 24 hours postoperatively
Drahonovsky 2006	It appeared that only part of the collected data (i.e. 2 instead of 3 intervention groups) were reported in the study published in 2006, which was included in the 2009 update of this review. In a paper published in 2010, 3 intervention groups were reported, including the 2 described in the paper of 2006 and the missing third group. However, the study design (e.g. randomisation procedure) was insufficiently described to clarify this discrepancy. After requesting from the authors more information on the study design, we received too little information to assess the study for inclusion and exclusion criteria. Therefore, we excluded both papers from 2006 and 2010 from this review
Drahonovsky 2010	See Drahonovsky 2006
Dua 2012	No comparison between routes of hysterectomy; women were randomised to have a drain or no drain after VH
Elessawy 2020	This study was not a randomised controlled trial. Intraoperative and postoperative parameters for robotic‐assisted laparoscopic hysterectomy and conventional total laparoscopic hysterectomy affecting the patients’ quality of life were assessed by a telephone‐based questionnaire.
Ellstrom 2003	Randomised trial of TLH versus AH (n = 74), but did not measure any of our pre‐specified outcomes, focusing on psychological well‐being. No differences were found
Fanfani 2013	This randomised controlled trial was excluded because 40 out of 68 included patients had surgery for non‐benign indications. The data on the 28 patients with benign indications were not reported separately
Fathi 2022	This study included both patients with benign as well as malignant disease. The researchers did not separate analyses for the diagnoses.
Ghanbari 2009	No comparison between different routes of hysterectomy; this randomised, double‐blind study compared 2 laparotomy techniques: transverse muscle‐cutting Maylard incision and the Pfannenstiel incision for AH
Ghezzi 2011	During the 2022 update we decided that using 3 mm port sites versus standard 5 mm port sites for laparoscopic hysterectomy would not constitute its own route of hysterectomy and therefore decided to exclude this study from the review
Hahlin 1994	Women included in another publication on the same outcome measures
Holub 2000	Randomised controlled trial (n = 70) but compared 2 variants of LAVH (described in the study as LAVH and VALH (vaginally assisted laparoscopic hysterectomy) respectively), rather than comparing LAVH with another surgical approach. In LAVH, the round ligament, upper broad ligament, infundibulopelvic or uteroovarian ligament, bladder pillars in preparation of the bladder flap were taken laparoscopically; the uterine vessels, cardinal‐uterosacral ligaments, anterior and posterior culdotomy and vaginal cuff closure were taken vaginally. In VALH, all steps were performed laparoscopically, other than taking the uterine vessels and vaginal cuff closure, which were performed vaginally. Operation time shorter for VALH (mean 81.33 versus 89.47 minutes, P value = 0.01), with no other significant differences in outcomes reported
Horng 2004	Randomised controlled trial (n = 541) but compared 2 variants of colpotomy in LAVH (vaginal and laparoscopic approach), rather than comparing LAVH with another surgical approach. The vaginal approach was associated with significantly fewer urinary tract injuries as compared with the laparoscopic approach (9/274 and 1/267 respectively)
Howard 1993	Not a randomised controlled trial. Allocated to study groups based on the attending physician scheduled for the case. Intervention: laparoscopic hysterectomy (LH) versus abdominal hysterectomy (AH)
Kim 2010	The study was excluded from the meta‐analysis because the primary outcome was on laboratory results and not on clinical data comparing routes of hysterectomy
Kucukozkan 2011	No comparison between routes of hysterectomy; patient with large symptomatic myomas were randomised for an abdominal approach through minilaparotomy or midline incision
Lee 2011	This study is a prospective case‐control study and not a RCT
Li 2012	Not a true randomised trial; patients were assigned to receive single‐port TLH or conventional TLH according to the sequence of their admission
Long 2005	Randomised controlled trial (n = 68) but compared 2 variants of LH(a) (with and without vaginal cuff suspension), rather than comparing LH(a) with another surgical approach. Less mobility of the bladder neck was found on ultrasound in LH(a) with suspension
Lönnerfors 2015	Randomisation between robot‐assisted hysterectomy and traditionale minimal invasive hysterectomy, however the route of traditional minimally invasive surgery was chosen by the designated surgeon, with vaginal hysterectomy as the first choice, followed by laparoscopic hysterectomy. Excluded because this makes it not a true randomised trial. 96 patients were found to be needed after their power analysis, while they indicate in the trial register on clinicaltrials.gov that they wanted to include 200 patients. Possibility of post hoc powering?
Mahmood 2015	Not enough information available to determine if study was randomised. We reached out to authors multiple times for clarification but did not hear back.
Martínez‐Maestre 2013	Patients were allocated to either conventional video‐assisted laparoscopy or robotic assistance, with da Vinci system. The allocation was depending on the patient ´s position on a hospital waiting list and the availability of the interdivisional robot on the planned day of surgery. Excluded because of quasi‐randomised design
Morelli 2007	Case of scientific felony at Magna Graecia University of Catanzaro (via http://www.ncbi.nlm.nih.gov/pubmed/17923838)
Moustafa 2008	No comparison between routes of hysterectomy; this randomised prospective study among women undergoing VH compared a closed vault technique with an open technique
Møller 2001	This study was excluded from the review and meta‐analysis because this was not a randomised controlled trial. Patients were allocated to study groups by the attending gynaecologist in a non‐randomised manner. Intervention: laparoscopic hysterectomy (LH) versus abdominal hysterectomy (AH)
Nezhat 1992	Not a randomised controlled trial: alternatively assigned to study groups. Intervention: laparoscopic hysterectomy (LH) versus abdominal hysterectomy (AH)
Oscarsson 2006	Randomised trial comparing subtotal AH versus subtotal LH (n = 47). The complication profile for subtotal hysterectomy is different to total hysterectomy. Inclusion of this trial and pooling for meta‐analysis would introduce undue clinical heterogeneity. ASH was performed by Pfannenstiel incision and excision of the uterus in the cervical isthmus region after dissection of the uterine arteries LSH was performed by a 3‐port technique. Adnexal pedicles were dissected with bipolar coagulation and unipolar scissors. Uterine arteries were exposed prior to unipolar uterine dissection. Morcellation of the uterus with 20 mm automatic morcellator. Bipolar coagulation of the endocervical mucosa. Primary outcome: hospital stay Secondary outcomes: operation time, complications according to patient and physician, pain, pain medication, Foley catheter removal, return to fluid and food intake, return to normal activities and work, patient satisfaction Operation time was longer for subtotal LH, intra‐operative blood loss was higher for subtotal AH, VAS pain was higher for subtotal AH at 6 hours after surgery, return to work was sooner after subtotal LH. Other comparisons were not different
Pabuccu 1996	No further data provided by author
Pan 2008	Not a comparison of 2 different types of hysterectomy. In this study, 2 different techniques with regard to time point of coagulation of uterine vessels during LH(a) were compared
Park 2003	Not a randomised controlled trial; historical comparison of LAVH and TLH
Petrucco 1999	No further data provided by author
Phipps 1993	Not a true randomised controlled trial; allocated to study groups according to the last digit of their hospital record number by secretarial staff. Intervention: laparoscopic hysterectomy (LH) with bilateral salpingo‐oophorectomy (BSO) versus abdominal hysterectomy (AH) with BSO
Polat  2016	Excluded because the study does not report any of the defined outcome measures of the current update of this review
Seow 2010	No comparison between routes of hysterectomy; this randomised controlled trial compared wound bleeding after injecting the colpotomy wound in LAVH with diluted vasopressin versus normal saline solution
Sulochana 2021	This is a non‐randomised study
Tchartchian 2016	Excluded because of randomisation based on year of birth is not trustworthy; in addition, insufficient distinction has been made between the two surgical techniques: we judge that this is not another route of a hysterectomy
Uccella 2018	The study was excluded because the only difference was the method of cuff closure (patients undergoing total laparoscopic hysterectomy for benign indications were randomised at the time of colpotomy to receive vaginal closure through transvaginal vs laparoscopic approach). We have decided that the method cuff closure alone does not make it a different route of hysterectomy.
Wijk 2018	Excluded because it included benign as well as malignant cases
Yue 2009	The study was excluded from the meta‐analysis because the primary outcome was based on laboratory results and not on clinical data comparing routes of hysterectomy

AH: abdominal hysterectomy
ASH: subtotal abdominal hysterectomy
CPK: creatine phosphokinase
CRP: C‐reactive protein
IL‐6: interleukin 6
LAVH: laparoscopic‐assisted vaginal hysterectomy
LH: laparoscopic hysterectomy
LSH: subtotal laparoscopic hysterectomy
RCT: randomised controlled trial
TLH: total laparoscopic hysterectomy
VALH: vaginally assisted laparoscopic hysterectomy
VAS: visual analogue scale
VH: vaginal hysterectomy

Characteristics of studies awaiting classification [ordered by study ID]

Chrysostomou 2021.

Methods	Randomised controlled trial comparing vaginal hysterectomy to laparoscopically‐assisted vaginal hysterectomy Surgical procedures were performed by the residents in training under the supervision of specialists with large experience
Participants	Women admitted between January 2017 and December 2019 for hysterectomy due to benign conditions Inclusion criteria: vaginally accessible uterus, estimated uterine size ≤ 12 weeks of gestation or ≤ 280 g on ultrasound examination and pathology confined to the uterus
Interventions	VH vs LAVH
Outcomes	Primary objectives: blood loss, operation time and cost differences Secondary objectives: differences in hospital stay, need for postoperative analgesia, intra‐ and immediate postoperative complications, and the rate of conversion to laparotomy
Notes

Sajjad 2021.

Methods	Randomised controlled trial Group A: vaginal hysterectomy Group B: abdominal hysterectomy
Participants	Women with dysfunctional uterine bleeding with failed medical treatment, age 45 to 55 years, uterus of less than 14 weeks size, hysterectomy for benign pathology and primary para or multipara
Interventions	VH vs AH
Outcomes	Comparison of satisfactory quality of life between vaginal hysterectomy and abdominal hysterectomy
Notes

LAVH: laparoscopic‐assisted vaginal hysterectomy
TLH: total laparoscopic hysterectomy
VH: vaginal hysterectomy

Characteristics of ongoing studies [ordered by study ID]

NCT04886791.

Study name	VANH trial
Methods	Single‐blinded, multicentre randomised controlled trial
Participants	Eligible women who fulfil the inclusion criteria and will undergo a hysterectomy for a benign indication
Interventions	The study population will be randomly allocated to the VANH group, who will undergo a vaginal assisted NOTES hysterectomy (intervention group) or the vaginal hysterectomy group (control group) and the participants will be single blinded. The pre‐ and postoperative care will be the same for both groups.
Outcomes	Primary outcome is the percentage of patients that underwent the hysterectomy as in SDD setting. A total of 41 patients should be included in the control group and a total of 83 patients in the intervention group, using an enrolment ratio of 1:2, with an alpha of 0.05 and a power of 0.8. The secondary outcomes are complications, treatment‐related outcomes, postoperative recovery, quality of life and cost‐effectiveness
Starting date	5 July 2021
Contact information	+31 640970334 il.bekkers@zuyderland.nl
Notes

NCT05031182.

Study name	Tolerance of the vNOTES surgical technique in total hysterectomy for benign lesion. Clinical trial of non‐inferiority compared to the laparoscopic technique
Methods	Allocation: randomised Intervention model: parallel assignment Masking: none (open‐label) Primary purpose: treatment
Participants	Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy
Interventions	Procedure: laparoscopy The hysterectomy is performed by laparoscopy as described in the EMC Procedure: V‐NOTES The hysterectomy is performed by V‐NOTES as described Dr Baekelandt and his team
Outcomes	Per and postoperative complications will be studied and noted up to 6 months postoperatively
Starting date	11 October 2021
Contact information	Contact: Lise Laclautre 334 73 754 963 promo_interne_drci@chu‐clermontferrand.fr
Notes

V‐NOTES: vaginal natural orifice transluminal endoscopic surgery

Differences between protocol and review

There are now various differences between the protocol (published in 2002) and this version of the review:

1. New types of hysterectomy have been added. These include single‐port laparoscopic hysterectomy, robot‐assisted hysterectomy and V‐NOTES hysterectomy.

2. While not included in the original protocol, we have excluded two types of hysterectomy included in the prior published review, as we no longer consider mini‐laparoscopic hysterectomy and mini‐laparotomy different from LH or AH respectively.

3. Haemoglobin or haematocrit drop and "other intraoperative complication" have been removed from the list of secondary outcomes.

4. The outcomes in the summary of findings (SOF) tables have been edited for clinical relevance. They now include our primary outcomes and three of our secondary outcomes (vaginal cuff infection, wound/abdominal wall infection and febrile episodes). We no longer report vascular injury, bowel injury, bleeding or unintended laparotomy in the SOF tables.

Contributions of authors

Charlotte Pickett: extracted data for the current update, assisted with data entry and analysis, and wrote the current update.

Dachel Seeratan: assisted with data extraction and data entry, and wrote the current update.

Tijmen Bonestroo: study selection and data extraction for the current update, assisted with data entry and analysis, wrote the current update.

Theodoor E Nieboer: assisted with data extraction and interpretation, commented on the current update.

Neil Johnson: conceptualised the first review, wrote the protocol and the review, helped supervise the selection of trials and data extraction, and commented on the current update.

Ben Willem Mol: assisted with data extraction and interpretation, commented on the current update.

Johanna WM Aarts: selected trials and extracted data for the current update, performed data entry, wrote and supervised the current update of the review.

Sources of support

Internal sources

• No internal source of support, Other

  None

External sources

• No external source of support, Other

  None

Declarations of interest

Charlotte Pickett has no declarations of interest.

Dachel Seeratan has no declarations of interest.

Tijmen Bonestroo has no declarations of interest.

Theodoor E Nieboer has no declarations of interest.

Neil Johnson is a fiduciary officer of World Endometriosis Society and Asia Pacific Initiative in Reproduction (ASPIRE); has received financial remuneration for consultancies from Myovant Sciences and Roche Diagnostics GmbH; and has received research funding from Guerbet and Abbott Pharmaceuticals.

Ben Willem Mol has received financial remuneration for consultancies from Merck, Guerbet LLC and ObcEva.

Johanna WM Aarts has no declarations of interest.

New search for studies and content updated (conclusions changed)