Purse‐string skin closure versus linear skin closure in people undergoing stoma reversal

Abstract

Background

Stoma reversal is associated with a relatively high risk of surgical site infection (SSI), occurring in up to 40% of cases. This may be explained by the presence of microorganisms around the stoma site, and possible contamination with the intestinal contents during the open‐end manipulation of the bowel, making the stoma closure site a clean‐contaminated wound. The conventional technique for stoma reversal is linear skin closure (LSC). The purse‐string skin closure (PSSC) technique (circumferential skin approximation) creates a small opening in the centre of the wound, enabling free drainage of contaminants and serous fluid. This could decrease the risk of SSI compared with LSC.

Objectives

To assess the effects of purse‐string skin closure compared with linear skin closure in people undergoing stoma reversal.

Search methods

We searched CENTRAL, MEDLINE, Embase, two other databases, and three trials registers on 21 December 2022. We also checked references, searched for citations, and contacted study authors to identify additional studies.

Selection criteria

We included all randomised controlled trials (RCTs) comparing PSSC and LSC techniques in people undergoing closure of stoma (loop ileostomy, end ileostomy, loop colostomy, or end colostomy) created for any indication.

Data collection and analysis

Two review authors independently selected eligible studies, extracted data, evaluated the methodological quality of the included studies, and conducted the analyses. The most clinically relevant outcomes were SSI, participant satisfaction, incisional hernia, and operative time. We calculated odds ratios (ORs) for dichotomous data and mean differences (MDs) for continuous data, each with its corresponding 95% confidence interval (CI). We used the GRADE approach to rate the certainty of the evidence.

Main results

Nine RCTs involving 757 participants were eligible for inclusion. Eight studies recruited only adults (aged 18 years and older), and one study included people aged 12 years and older. The participants underwent elective reversal of either ileostomy (82%) or colostomy (18%). We considered all studies at high risk of performance and detection bias (lack of blinding) and four studies at unclear risk of selection bias related to random sequence generation.

PSSC compared with LSC likely reduces the risk of SSI (OR 0.17, 95% CI 0.09 to 0.29; I² = 0%; 9 studies, 757 participants; moderate‐certainty evidence). The anticipated absolute risk of SSI is 52 per 1000 people who have PSSC and 243 per 1000 people who have LSC.

The likelihood of being very satisfied or satisfied with stoma closure may be higher amongst people who have PSSC compared with people who have LSC (100% vs 89%; OR 20.11, 95% CI 1.09 to 369.88; 2 studies, 122 participants; low‐certainty evidence).

The results of the analysis suggest that PSSC compared with LSC may have little or no effect on the risk of incisional hernia (OR 0.51, 95% CI 0.07 to 3.70; I² = 49%; 4 studies, 297 participants; very low‐certainty evidence) and operative time (MD −2.67 minutes, 95% CI −8.56 to 3.22; I² = 65%; 6 studies, 460 participants; very low‐certainty evidence).

Authors' conclusions

PSSC compared with LSC likely reduces the risk of SSI in people undergoing reversal of stoma. People who have PSSC may be more satisfied with the result compared with people who have LSC. There may be little or no difference between the skin closure techniques in terms of incisional hernia and operative time, though the evidence for these two outcomes is very uncertain.

Plain language summary

Comparing two methods of wound closure in stoma reversal: purse‐string closure versus linear skin closure.

Key messages

• Purse‐string skin closure (PSSC) probably reduces the risk of wound infection compared with linear skin closure (LSC).
• People who have PSSC may be more satisfied with the result compared with people who have LSC.

What does stoma reversal mean?

An intestinal stoma is a surgically created intestinal opening on the surface of the abdomen. People with a temporary stoma will have their stoma reversed a few months after the initial operation (when the stoma was created). Up to 40% of people who have stoma reversal develop a wound infection, mainly due to the presence of bacteria around the stoma site.

What techniques are available for closing stomas?

The conventional technique for reversing a stoma is linear skin closure (LSC; closure of the wound in a straight line), but this technique is associated with a high risk of wound infection. An alternative technique is called purse‐string skin closure (PSSC; a continuous stitch that closes the round stoma wound, similar to the way a thread closes a purse‐string bag). PSSC leaves a small opening in the centre of the wound, enabling free drainage of contaminants and thus potentially decreasing the risk of wound infection.

What did we want to find out?

We wanted to find out if the PSSC technique was better than the LSC technique for improving:

• risk of wound infection;
• patient satisfaction;
• risk of incisional hernia (where tissue pokes though the surgical wound); and
• operative time.

What did we do?

We searched for studies that compared PSSC with LSC in people undergoing reversal of stoma. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes.

What did we find?

We found nine studies that involved 757 people undergoing reversal of stoma.

PSSC probably reduces the risk of wound infection compared with LSC. For every 1000 people who have PSSC, 52 will develop a wound infection, compared with 243 of every 1000 people who have LSC.

People who have PSSC may be more satisfied with the result compared with people who have LSC. In the studies included in this review, all participants in the PSSC group said they were satisfied or very satisfied with the stoma closure, compared with 89% of participants in the LSC group.

There may be little or no difference between the two techniques in the risk of incisional hernia or in operative time, but the results are very uncertain.

What are the limitations of the evidence?

We are moderately confident about our conclusions regarding wound infection, because each participant knew what technique they had been assigned to, as did the person performing the stoma closure. Higher‐quality studies are needed to provide stronger evidence about participant satisfaction, incisional hernia, and operative time.

How up to date is this evidence?

The evidence is current to 13 December 2022.

Summary of findings

Summary of findings 1. Summary of findings table ‐ Purse‐string skin closure compared to linear skin closure in people undergoing stoma reversal.

Purse‐string skin closure compared to linear skin closure in people undergoing stoma reversal
Patient or population: people undergoing stoma reversal Setting: general and colorectal surgery Intervention: purse‐string skin closure Comparison: linear skin closure
Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Risk with linear skin closure	Risk with purse‐string skin closure
Surgical site infection follow‐up: 30 days	243 per 1000	52 per 1000 (28 to 85)	OR 0.17 (0.09 to 0.29)	757 (9 RCTs)	⊕⊕⊕⊝ Moderatea
Participant satisfaction (very satisfied or satisfied) follow‐up: mean 12 months	885 per 1000	994 per 1000 (894 to 1000)	OR 20.11 (1.09 to 369.88)	122 (2 RCTs)	⊕⊕⊝⊝ Lowa,b
Incisional hernia follow‐up: mean 6 months	55 per 1000	29 per 1000 (4 to 177)	OR 0.51 (0.07 to 3.70)	297 (4 RCTs)	⊕⊝⊝⊝ Very lowa,b
Operative time		MD 2.67 lower (8.56 lower to 3.22 higher)	‐	460 (6 RCTs)	⊕⊝⊝⊝ Very lowa,b,c
*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; MD: mean difference; OR: odds ratio
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.
See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_438803824800974662.

^a Downgraded for risk of bias (performance and detection bias).
^b Downgraded for imprecision (wide CI of summary measure).
^c Downgraded for inconsistency (substantial heterogeneity).

Background

Description of the condition

Intestinal stoma, which is a surgically created intestinal opening on the surface of the abdomen, is formed to divert intestinal content in both emergency and elective abdominal surgery settings (Ambe 2018). It is estimated that more than 170,000 people in the UK have some type of stoma (Kettle 2019). The most common conditions that require surgery with the creation of an intestinal stoma include colorectal cancer, inflammatory bowel disease, and abdominal trauma (Ambe 2018). The most common types of intestinal stomas are ileostomy (opening of small intestine on the surface of the abdomen) and colostomy (opening of large intestine on the surface of the abdomen; Ambe 2018). Stomas can be temporary or permanent, depending on the indication for creating them (Taylor 2005). A temporary stoma may be created when protection of distal primary anastomosis is required (e.g. in low colorectal or coloanal anastomosis), when primary anastomosis is not possible due to high risk of anastomotic insufficiency (e.g. in severe inflammation or significant size discrepancy between two bowel ends), or when temporary defunctioning of distal bowel is required (e.g. as a bridge to primary resection in an obstructing malignancy; de Bree 2018; Tan 2009; Tartaglia 2019). Although stomas are formed to prevent further complications, they are associated with complications themselves (such as pain, prolapse, and parastomal hernia) and can negatively impact patients' quality of life, which highlights the need for stoma reversal within a few weeks or months after the primary procedure, if possible (Hubbard 2020; Randall 2012; Shabbir 2010). Stoma reversal is associated with complications, such as surgical site infection (SSI), intestinal obstruction, incisional hernia, and anastomotic leak (Hajibandeh 2018). SSI is the most common complication following reversal of a stoma, occurring in up to 40% of cases (Wong 2005). This may be due to the presence of microorganisms around the stoma site, and possible contamination with the intestinal content during the open‐end manipulation of the bowel, making the stoma closure site a clean‐contaminated wound (Kaidar‐Person 2005).

Description of the intervention

The conventional technique for stoma reversal is linear skin closure (LSC). However, this technique is associated with a relatively high risk of SSI in people undergoing stoma reversal, which has motivated researchers to investigate alternative skin closure techniques (Hajibandeh 2018). Purse‐string skin closure (PSSC; a circumferential skin approximation technique) was first described in stoma site closure in Banerjee 1997. The PSSC technique creates a small opening in the centre of the wound, enabling free drainage of contaminants and serous fluid. This is considered the main advantage of the technique, and is consistent with management principles of an infected and contaminated wound, where the wound is left open for healing by secondary intention (Banerjee 1997). PSSC may have a lower risk of seroma formation and thus lead to faster wound healing. However, one possible disadvantage of the PSSC technique is a prolonged wound care period. Additionally, if there is a need to increase the length of the incision during stoma reversal, closure of a non‐circular wound by the PSSC technique may be challenging (Neumann 2020).

How the intervention might work

The presence of a small orifice in the centre of the wound created by the PSSC technique allows free drainage of contaminants and healing by secondary intention, which could help to reduce the risk of SSI (Hajibandeh 2018). Randomised and non‐randomised studies have found that the PSSC technique significantly reduces the risk of SSI and increases patient satisfaction compared with the LSC technique, without increasing the risk of other complications (Hajibandeh 2018). One meta‐analysis estimated that the risk of SSI associated with PSSC is less than 5%, while the risk of SSI associated with LSC is greater than 15% (Hajibandeh 2018). These findings suggest that PSSC could be a promising skin closure technique in people undergoing stoma reversal (Hajibandeh 2020).

Why it is important to do this review

SSI following reversal of a stoma results in increased morbidity and poor quality of life (Chow 2009; Vermulst 2006). For this reason, it is important to establish the most effective skin closure technique for stoma reversal. Although one meta‐analysis of randomised and non‐randomised studies suggested the PSSC technique may be associated with a lower risk of SSI and better patient satisfaction (Hajibandeh 2018), the available evidence has not led to a widespread change in practice, and LSC remains the technique of choice for most surgeons (Hajibandeh 2020). This review would provide the best available evidence on outcomes of PSSC versus LSC in people undergoing stoma reversal, which could help to identify the most effective technique.

Appendix 1 presents a glossary of the terms used in this review.

Objectives

To assess the effects of purse‐string skin closure compared with linear skin closure in people undergoing stoma reversal.

Methods

Criteria for considering studies for this review

Types of studies

We included all randomised controlled trials (RCTs) comparing PSSC and LSC techniques in people undergoing stoma reversal. We did not include quasi‐randomised trials due to concerns regarding the bias associated with selection of participants into the intervention groups.

Types of participants

Participants of any age and sex undergoing closure of stoma (created for any indication) were eligible for inclusion. We considered participants undergoing closure of the following stomas (either individual interventions or combined).

• Loop ileostomy

• End ileostomy

• Loop colostomy

• End colostomy

To be considered eligible, all studies had to be originally designed based on comparing PSSC and LSC techniques in people undergoing stoma reversal; therefore, we excluded studies that reported outcomes of each technique as a subgroup analysis. When only a subset of participants in a study met our eligibility criteria, we only included the study if separate data (baseline demographics and outcomes) were available for the participants of interest.

Types of interventions

The intervention of interest was PSSC, defined as circumferential subcuticular skin closure in a purse‐string manner, leaving a central aperture to allow healing by secondary intention. The comparator of interest was LSC, defined as a conventional LSC technique using interrupted or continuous subcutaneous sutures or skin clips.

Types of outcome measures

Primary outcomes

• SSI, defined as superficial infection (involving only skin and subcutaneous tissue of the incision), deep infection (involving deep soft tissue such as fascia or muscle of the incision), or both, occurring within 30 days following the operation. Based on the results of previous studies, we considered the minimally important difference for this outcome as more than 10% difference in the risk of SSI (Hajibandeh 2018; Hajibandeh 2020).

• Participant satisfaction, assessed at one month, three months, and six months postoperatively by itemised questionnaires that measure the outcome using a visual analogue scale (VAS; Alvandipour 2016) or Likert scale (Sureshkumar 2018). Eligible questionnaires included the Patient and Observer Scar Assessment Scale (POSAS; Alvandipour 2016), the Body Image Questionnaire (BIQ; Dusch 2013); and the 36‐item Short‐Form Health Survey (SF‐36; Sureshkumar 2018). If a study reported participant satisfaction using more than one questionnaire, we extracted the data related to all questionnaires and analysed the data separately.

Secondary outcomes

• Incisional hernia, defined as clinical or radiological evidence of hernia at the stoma closure site at longest follow‐up in each study

• Anastomotic leak, defined as radiological diagnosis (air or fluid collection in proximity to an anastomosis or extravasation of contrast on computed tomography (CT) scan) or evident anastomotic dehiscence at reoperation within 30 days of the original operation, or both

• Intestinal obstruction, defined as clinical and radiological evidence of small or large bowel obstruction within 30 days of the operation

• Operative time, defined as the time in minutes between incision of the skin (start of the operation) and closure of the skin (end of the operation)

• Length of hospital stay, defined as the time in days between the day of operation and day of discharge from hospital

Studies that reported any of our primary or secondary outcomes were eligible for inclusion.

Search methods for identification of studies

Electronic searches

We searched the following electronic databases.

• Ovid MEDLINE (1946 to 21 December 2022)

• Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library (searched 21 December 2022)

• Embase (1974 to 21 December 2022)

• CINAHL EBSCOhost (1980 to 21 December 2022)

We adapted our search strategy with thesaurus headings and search operators for each of the above databases. There were no time period, publication format, or language restrictions on the search. In addition, to identify details of ongoing and unpublished trials, we searched the following trial registries.

• World Health Organization (WHO) International Clinical Trials Registry (apps.who.int/trialsearch; searched 21 December 2022)

• U.S. National Institutes of Health Ongoing Trials Registry ClinicalTrials.gov (clinicaltrials.gov; searched 21 December 2022)

• ISRCTN Register (www.isrctn.com; searched 21 December 2022)

The literature search strategies for the above databases are outlined in Appendix 2, Appendix 3, Appendix 4, and Appendix 5.

Searching other resources

We checked the reference lists of all included studies and relevant systematic reviews identified by the search for further potentially eligible trials.

Data collection and analysis

Selection of studies

Two review authors (SH, SH) independently screened the articles identified through our search strategies. The process of screening involved reading the titles and abstracts of the identified articles followed by full‐text retrieval and selection of potentially eligible studies. A third review author (AM) resolved any disagreements.

Data extraction and management

We developed an online data extraction sheet consistent with Cochrane's data collection form for intervention reviews, and we piloted our data extraction sheet on at least one included trial. Two review authors (SH, SH) independently extracted the following data.

• First author

• Country of origin

• Year and journal of the published study

• Study design

• Sample size

• Clinical condition of the study participants

  • Age

  • Sex

  • Body mass index (BMI)

  • Comorbidities

• Type of stoma

• Time from original operation to stoma reversal

• Suture materials used for skin closure

• Use of drain

• Use of mesh

• Outcome data

• Funding and conflicts of interest

Where eligible studies had more than two treatment arms, we extracted relevant data only from the arms being treated with interventions of interest in this review (PSC or LSC techniques). A third review author (AM) resolved any disagreements.

Assessment of risk of bias in included studies

Two review authors (SH, SH) independently assessed the risk of bias in each included study using the Cochrane risk of bias tool (RoB 1), which covers the following domains (Higgins 2017).

• Allocation (selection bias)

• Blinding (performance bias and detection bias)

• Incomplete outcome data (attrition bias)

• Selective reporting (reporting bias)

• Other potential sources of bias

We classified each trial at low, unclear, or high risk of bias for each domain. A third review author (AM) resolved any disagreements. We based the risk of bias assessment of individual studies on the objectively assessed outcomes.

Measures of treatment effect

For dichotomous outcome variables (SSI, anastomotic leak, incisional hernia, intestinal obstruction), we calculated the odds of an event in the PSSC group compared to the LSC group and reported this as the odds ratio (OR). An OR of less than 1 would favour the PSSC group and an OR of more than 1 would favour the LSC group. For continuous outcome variables (participant satisfaction, operative time, length of hospital stay), we calculated the mean difference (MD) between the two groups. We planned to calculate the standardised mean difference (SMD) for any continuous outcome that was measured on different scales in different studies. We calculated and reported 95% confidence intervals (CIs) alongside all summary measures.

Unit of analysis issues

We considered the individual participant as the unit of analysis in this review. Had we identified any studies with more than two arms, we would have collected and combined only data relevant to the intervention and comparison of interest to create a single pairwise comparison. If we had found any eligible cluster‐randomised trials, the unit of analysis would have been the individual participant rather than the cluster (we would have considered the total number of participants and total number of events reported in the intervention and control groups).

Dealing with missing data

We recorded information about dropouts, withdrawals, and other missing data (baseline characteristics, interventions, and outcomes), and if not reported, we contacted the study authors to request the relevant information. We based our final analyses on the available data from each trial, provided that participants had been analysed in their original groups.

Assessment of heterogeneity

We used the Chi² test to evaluate statistical heterogeneity and the I² statistic to quantify statistical heterogeneity. We interpreted the I² values as follows (Higgins 2022).

• 0% to 40%: might not be important

• 30% to 60%: may represent moderate heterogeneity

• 50% to 90%: may represent substantial heterogeneity

• 75% to 100%: considerable heterogeneity

We assessed clinical heterogeneity based on the comparability of the included trials in terms of baseline demographics of participants, type of stoma, type of suture materials used for skin closure, use of drain, and definition of the outcomes.

Assessment of reporting biases

Had we included more than 10 trials in any meta‐analysis, we would have constructed a funnel plot and visually assessed funnel plot symmetry to evaluate publication bias.

Data synthesis

We used RevMan Web for data synthesis (RevMan Web). One review author (SH) entered the data related to each outcome into RevMan Web, and a second review author (SH) checked the data. We used a random‐effects model for the analyses. We reported the results in forest plots with 95% CIs. We did not attempt meta‐analysis of an outcome when there was significant clinical heterogeneity in terms of outcome definition, outcome assessment, and closure techniques. If we considered statistical pooling of data to be inappropriate for an outcome, we reported the results of individual trials for that outcome narratively.

Subgroup analysis and investigation of heterogeneity

Where possible, depending on the available data, we planned to perform separate analyses for the following subgroups.

• Participants with ileostomy (rationale: ileostomies are different from colostomies in terms of content, anatomy, and size of defect; hence the outcomes of participants with ileostomies and colostomies may be different)

• Participants with colostomy (rationale: ileostomies are different from colostomies in terms of content, anatomy, and size of defect; hence the outcomes of participants with ileostomies and colostomies may be different)

• Participants with wound drain (rationale: use of drain could reduce the risk of SSI in people undergoing LSC and so could make PSSC and LSC comparable in terms of SSI)

• Immunodeficient participants (rationale: immunodeficiency may increase the risk of SSI and may influence the outcome of each technique in terms of SSI)

Sensitivity analysis

We performed sensitivity analyses to assess the impact of notable assumptions, imputed data, borderline decisions, and studies at high risk of bias on direction of effect sizes and overall heterogeneity. We planned to repeat the analyses including only trials with the following characteristics.

• Prophylactic use of antibiotics

• Stoma closure during adjuvant chemotherapy

• Low risk of selection bias related to randomisation

• Low risk of selection bias related to allocation concealment

• Low risk of bias related to blinding

Summary of findings and assessment of the certainty of the evidence

We compiled and summarised the best evidence on the following clinically relevant outcomes, which we consider are essential for decision‐making.

• SSI (time point: 30 days postoperatively)

• Participants satisfaction (time point: up to six months postoperatively)

• Incisional hernia (time point: at least one year postoperatively)

• Operative time (time point: not applicable).

We included both desirable and undesirable outcomes. We computed the assumed control intervention risks based on the mean number of events in control groups of selected studies for each outcome. We presented the results in a summary of findings table (Schünemann 2022).

Two independent review authors (SH, SH) applied the GRADE system to rate the certainty of available evidence for each outcome included in the summary of findings table (Schünemann 2013). A third review author (AM) resolved any disagreements. We judged the certainty of available evidence to be very low, low, moderate, or high, based on the following domains.

• Study limitations (risk of bias)

• Inconsistency of results

• Indirectness of evidence

• Imprecision

• Publication bias

Results

Description of studies

Results of the search

The search of electronic databases identified a total of 318 records (167 records without duplicates). We excluded 155 clearly irrelevant records during the title and abstract screen, then we retrieved the full‐text articles of the remaining records, where available. During the full‐text review, we listed three studies as awaiting classification because they were conference abstracts with inadequate information about their methodology, interventions, and included population. The remaining nine studies were eligible for inclusion (Ali 2021; Alvandipour 2016; Amano 2019; Camacho‐Mauries 2013; Dusch 2013; Lee 2014; O'Leary 2017; Reid 2010; Sureshkumar 2018). We identified no ongoing RCTs. Figure 1 shows the study selection process in a PRISMA diagram.

1.

Study flow diagram.

Included studies

Participants

The included studies randomised a total of 757 participants (387 in the PSSC group and 370 in the LSC group). Five RCTs included people undergoing reversal of ileostomy only (Ali 2021; Alvandipour 2016; Dusch 2013; O'Leary 2017; Reid 2010), and four RCTs included people undergoing reversal of ileostomy or colostomy (Amano 2019; Camacho‐Mauries 2013; Lee 2014; Sureshkumar 2018). In total, 618 participants underwent reversal of ileostomy, and 139 participants underwent reversal of colostomy. Eight studies reported comparable baseline characteristics in the PSSC and LSC groups (Ali 2021; Alvandipour 2016; Amano 2019; Camacho‐Mauries 2013; Dusch 2013; Lee 2014; O'Leary 2017; Sureshkumar 2018). In Reid 2010, the two groups were comparable in terms of age, BMI, and comorbidities, but the proportion of men was higher in the LSC group.

Intervention and comparison

PSSC was performed using subcuticular absorbable suture in six RCTs (Ali 2021; Alvandipour 2016; Amano 2019; Lee 2014; O'Leary 2017; Sureshkumar 2018) and subcuticular non‐absorbable suture in three RCTs (Camacho‐Mauries 2013; Dusch 2013; Reid 2010).

LSC was performed using interrupted non‐absorbable suture in seven RCTs (Ali 2021; Alvandipour 2016; Amano 2019; Camacho‐Mauries 2013; Dusch 2013; Lee 2014; Sureshkumar 2018), interrupted absorbable suture in one RCT (Reid 2010), and subcuticular absorbable suture in one RCT (O'Leary 2017).

Only Amano 2019 used wound drain in the LSC group. No RCTs used prophylactic mesh.

Excluded studies

We excluded no studies during the full‐text review. We listed three studies as awaiting classification because they were conference abstracts with inadequate information about the methodology, interventions, and included population (Borsuk 2022; Carannante 2022; Carter 2016). The Characteristics of studies awaiting classification table provides further details.

Risk of bias in included studies

Figure 2 shows our judgements about each risk of bias item presented as percentages across all included studies, and Figure 3 shows our judgements about each risk of bias item for each included study.

2.

Review authors' judgements about each risk of bias item presented as percentages across all included studies.

3.

Review authors' judgements about each risk of bias item for each included study.

Allocation

We judged five RCS at low risk of selection bias related to random sequence generation because the method and type of randomisation was described appropriately (Amano 2019; Lee 2014; O'Leary 2017; Reid 2010; Sureshkumar 2018). Four RCTs described the method of randomisation but not the type of randomisation, so we judged them at unclear risk of bias in this domain (Ali 2021; Alvandipour 2016; Camacho‐Mauries 2013; Dusch 2013).

The method used for randomisation supported allocation concealment in eight RCTs (Ali 2021; Amano 2019; Camacho‐Mauries 2013; Dusch 2013; Lee 2014; O'Leary 2017; Reid 2010; Sureshkumar 2018). We considered Alvandipour 2016 at high risk of selection bias for this domain because allocation concealment was inadequate.

Blinding

We considered all RCTs at high risk of performance and selection bias, as participants, personnel, and outcome assessors were not blinded. Blinding may be unfeasible in this setting owing to the obvious difference in appearance of the two closure techniques.

Incomplete outcome data

All RCTs were at low risk of attrition bias because they had complete outcome data for all participants.

Selective reporting

We detected no selective reporting in six RCTs (Ali 2021; Alvandipour 2016; Amano 2019; Dusch 2013; Lee 2014; Reid 2010). Three RCTs provided inadequate information about protocol registration so were at unclear risk of reporting bias (Camacho‐Mauries 2013; O'Leary 2017; Sureshkumar 2018).

Other potential sources of bias

We detected no other sources of bias in eight RCTs (Ali 2021; Alvandipour 2016; Amano 2019; Camacho‐Mauries 2013; Dusch 2013; Lee 2014; Reid 2010; Sureshkumar 2018). The source of external funding was unclear in O'Leary 2017 (unclear risk of bias).

Effects of interventions

See: Table 1

Purse‐string skin closure versus linear skin closure (all participants)

Primary outcomes

Surgical site infection

All nine RCTs (757 participants) reported SSI within 30 days of the operation. The anticipated absolute risk of SSI is 52 per 1000 people who have PSSC and 243 per 1000 people who have LSC. PSSC compared with LSC likely reduces the risk of SSI (OR 0.17, 95% CI 0.09 to 0.29; I² = 0%; moderate‐certainty evidence; Analysis 1.1; Table 1).

1.1. Analysis.

Comparison 1: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): all participants, Outcome 1: Surgical site infection

Participant satisfaction

The outcome of participant satisfaction was heterogeneous across studies in terms of the scale itself, the way the scale was used, and reporting of measurements. Moreover, although six studies measured participant satisfaction (Ali 2021; Alvandipour 2016; Camacho‐Mauries 2013; Lee 2014; Reid 2010; Sureshkumar 2018), most reported satisfaction scores inadequately, without providing standard deviations of the mean score or interquartile range for the median score. Consequently, we synthesised and analysed participant satisfaction as two dichotomous outcomes: the number of participants classed as very satisfied or satisfied, and the number of participants classed as unsatisfied or very unsatisfied. Two RCTs (122 participants) assessed the outcome in this way, at six months (Camacho‐Mauries 2013), and at 12 months (Reid 2010).

Very satisfied or satisfied

The likelihood of being very satisfied or satisfied with stoma closure may be higher amongst people who have PSSC compared with people who have LSC (OR 20.11, 95% CI 1.09 to 369.88; 2 studies, 122 participants; low‐certainty evidence; Analysis 1.2; Table 1). The level of heterogeneity between the studies could not be estimated.

1.2. Analysis.

Comparison 1: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): all participants, Outcome 2: Participant satisfaction (very satisfied or satisfied)

Unsatisfied or very unsatisfied

Our meta‐analysis indicated a lower probability of being unsatisfied or very unsatisfied amongst people who had PSSC compared with people who had LSC (OR 0.05, 95% CI 0.00 to 0.91; 2 studies, 122 participants; Analysis 1.3). The level of heterogeneity between the studies could not be estimated.

1.3. Analysis.

Comparison 1: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): all participants, Outcome 3: Participant satisfaction (unsatisfied or very unsatisfied)

Secondary outcomes

Incisional hernia

Four RCTs (297 participants) reported incisional hernia (Ali 2021; Camacho‐Mauries 2013; Dusch 2013; Sureshkumar 2018). The anticipated absolute risk of incisional hernia is 29 per 1000 people who have PSSC and 55 per 1000 people who have LSC. PSSC compared with LSC may have little or no effect on the risk of incisional hernia, but the evidence is very uncertain (OR 0.51, 95% CI 0.07 to 3.70; I² = 49%; very low‐certainty evidence; Analysis 1.4; Table 1).

1.4. Analysis.

Comparison 1: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): all participants, Outcome 4: Incisional hernia

Anastomotic leak

Three RCTs (213 participants) reported anastomotic leak within 30 days of the operation (Ali 2021; Camacho‐Mauries 2013; Sureshkumar 2018). Our meta‐analysis indicated little or no difference between PSSC and LSC in the risk of anastomotic leak (OR 0.41, 95% CI 0.06 to 2.91; I² = 0%; Analysis 1.5).

1.5. Analysis.

Comparison 1: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): all participants, Outcome 5: Anastomotic leak

Intestinal obstruction

Two RCTs (145 participants) reported intestinal obstruction within 30 days of the operation (Camacho‐Mauries 2013; Dusch 2013). Our meta‐analysis indicated little or no difference between PSSC and LSC in the risk of intestinal obstruction (OR 1.07, 95% CI 0.40 to 2.85; I² = 0%; two studies; Analysis 1.6).

1.6. Analysis.

Comparison 1: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): all participants, Outcome 6: Intestinal obstruction

Operative time

Six RCTs (460 participants) reported operative time (Ali 2021; Alvandipour 2016; Dusch 2013; Lee 2014; O'Leary 2017; Reid 2010). There may be little or no difference in operative time between PSSC and LSC, but the evidence is very uncertain (MD −2.67 minutes, 95% CI −8.56 to 3.22; I² = 65%; very low‐certainty evidence; Analysis 1.7; Table 1).

1.7. Analysis.

Comparison 1: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): all participants, Outcome 7: Operative time (minutes)

Length of hospital stay

Six RCTs (460 participants) reported length of hospital stay (Ali 2021; Alvandipour 2016; Dusch 2013; Lee 2014; O'Leary 2017; Reid 2010). Our meta‐analysis indicated little or no difference between PSSC and LSC in length of hospital stay (MD −0.77 days, 95% CI −1.77 to 0.23; I² = 73%; Analysis 1.8).

1.8. Analysis.

Comparison 1: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): all participants, Outcome 8: Length of hospital stay (days)

Purse‐string skin closure versus linear skin closure (participants with ileostomy)

Primary outcomes

Surgical site infection

Five RCTs (344 participants) reported SSI (Ali 2021; Alvandipour 2016; Dusch 2013; O'Leary 2017; Reid 2010). Our meta‐analysis indicated a lower risk of SSI with PSSC versus LSC (OR 0.15, 95% CI 0.07 to 0.32; I² = 0%; Analysis 2.1).

2.1. Analysis.

Comparison 2: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): participants with ileostomy, Outcome 1: Surgical site infection

Participant satisfaction

Very satisfied or satisfied

Only Reid 2010 (61 participants) reported the number of participants classed as very satisfied or satisfied. All participants in both groups were very satisfied or satisfied, so we could not calculate the OR (Analysis 2.2).

2.2. Analysis.

Comparison 2: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): participants with ileostomy, Outcome 2: Participant satisfaction (very satisfied or satisfied)

Unsatisfied or very unsatisfied

Only Reid 2010 (61 participants) reported the number of participants classed as unsatisfied or very unsatisfied. No participants in either group were unsatisfied or very unsatisfied, so we could not calculate the OR (Analysis 2.3).

2.3. Analysis.

Comparison 2: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): participants with ileostomy, Outcome 3: Participant satisfaction (unsatisfied or very unsatisfied)

Secondary outcomes

Incisional hernia

Two RCTs (156 participants) reported incisional hernia (Ali 2021; Dusch 2013). Our meta‐analysis indicated little or no difference between PSSC and LSC in the risk of incisional hernia (OR 1.65, 95% CI 0.11 to 25.47; I² = 51%; Analysis 2.4).

2.4. Analysis.

Comparison 2: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): participants with ileostomy, Outcome 4: Incisional hernia

Anastomotic leak

Only Ali 2021 (72 participants) reported anastomotic leak. There was no anastomotic leak in either group, so we could not calculate the OR (Analysis 2.5).

2.5. Analysis.

Comparison 2: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): participants with ileostomy, Outcome 5: Anastomotic leak

Intestinal obstruction

Only Dusch 2013 (84 participants) reported intestinal obstruction. Our analysis indicated little or no difference between PSSC and LSC in the risk of intestinal obstruction (OR 0.94, 95% CI 0.30 to 2.98; Analysis 2.6).

2.6. Analysis.

Comparison 2: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): participants with ileostomy, Outcome 6: Intestinal obstruction

Operative time

Five RCTs (344 participants) reported operative time (Ali 2021; Alvandipour 2016; Dusch 2013; O'Leary 2017; Reid 2010). Our meta‐analysis indicated little or no difference in operative time between PSSC and LSC (MD −2.24 minutes, 95% CI −8.46 to 3.99; I² = 71%; Analysis 2.7).

2.7. Analysis.

Comparison 2: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): participants with ileostomy, Outcome 7: Operative time (minutes)

Length of hospital stay

Five RCTs (344 participants) reported length of hospital stay (Ali 2021; Alvandipour 2016; Dusch 2013; O'Leary 2017; Reid 2010). Our meta‐analysis indicated little or no difference in length of hospital stay between PSSC and LSC (MD −0.78 days, 95% CI −1.87 to 0.32; I² = 78%; Analysis 2.8).

2.8. Analysis.

Comparison 2: Purse‐string skin closure (PSSC) versus linear skin closure (LSC): participants with ileostomy, Outcome 8: Length of hospital stay (days)

Other subgroups

The available data from the included RCTs were inadequate to perform analyses for the following subgroups.

• Participants with colostomy

• Participants with wound drain

• Immunocompromised participants

Sensitivity analysis

We performed sensitivity analyses for SSI, incisional hernia, operative time, and length of hospital stay where at least four RCTs had contributed data to the outcome. Separate analysis of RCTs with prophylactic use of antibiotics, separate analysis of RCTs with low risk of selection bias related to randomisation, and separate analysis of RCTs with low risk of selection bias related to allocation concealment showed results consistent with the main analyses (sensitivity analyses not shown). Owing to lack of data regarding timing of stoma closure in relation to adjuvant chemotherapy, we could not perform sensitivity analysis based on RCTs with stoma closure during adjuvant chemotherapy. In addition, separate analysis for trials at low risk of bias related to blinding was not possible, as no RCTs were blinded.

Discussion

Summary of main results

Analysis of data from nine RCTs including a total 757 participants suggested that PSSC compared with LCS likely reduces the risk of SSI in people undergoing stoma reversal. People who have PSSC may be happier with the result compared with people who have LSC. There may be little or no difference between the skin closure techniques in terms of incisional hernia and operative time, though the evidence is very uncertain for these two outcomes. Findings were consistent when we restricted the analyses to participants with ileostomy only, and in all sensitivity analyses undertaken.

Overall completeness and applicability of evidence

We consider the evidence for SSI to be complete and applicable. All included RCTs measured risk of SSI, using similar definitions and measurement scales. The participants were representative of people who have stoma reversal in real practice, and the clinical and statistical heterogeneity for SSI were low.

However, the evidence for participant satisfaction was poor. Measurement and reporting of this outcome were heterogeneous across the included RCTs. Different RCTs used different scales, or used the same scale in different ways. Most RCTs reported the satisfaction score as mean or median, but without reporting the associated standard deviation or interquartile range. Therefore, we were unable to conduct a meaningful analysis of participant satisfaction as a continuous variable. Two RCTs reported participant satisfaction as dichotomous outcomes, classifying participants as very satisfied, satisfied, unsatisfied, and very unsatisfied. Consequently, we considered the available evidence on participant satisfaction to be incomplete and non‐conclusive.

In terms of secondary outcomes, reporting of operative time and length of hospital stay was better than for incisional hernia, anastomotic leak, and intestinal obstruction. Although all nine RCTs reported operative time and length of hospital stay, we were unable to analyse data from three RCTs because there were no standard deviations or interquartile ranges for the mean or median values. Nevertheless, there was no significant clinical heterogeneity (despite moderate statistical heterogeneity) among the remaining six RCTs, and we considered the results of the meta‐analysis to be conclusive.

Only three RCTs reported anastomotic leak, and two RCTs reported intestinal obstruction, possibly because investigators do not consider these to be clinically important outcomes when skin closure technique is the intervention of interest. Therefore, although the available evidence is incomplete, we do not believe further evidence synthesis is necessary for these outcomes when comparing skin closure techniques in stoma reversal.

There is inadequate evidence related to the effect of wound drains on outcomes of skin closure techniques in people undergoing stoma reversal. Moreover, we found no evidence on the effect of each technique in immunodeficient participants.

The RCTs were comparable in terms of setting and included population. Our results are applicable to any adult undergoing reversal of ileostomy or colostomy in an elective general surgery setting.

Quality of the evidence

For SSI, we downgraded the certainty of the evidence to moderate because of the risk of performance and detection biases related to lack of blinding in the included RCTs. However, in view of the obvious difference in appearance of the two closure techniques, blinding may be unfeasible in this setting.

For participant satisfaction, we downgraded the certainty of the evidence to low because of the risk of performance and detection biases related to lack of blinding in the included RCTs, and because of concerns regarding imprecision of the effect size.

The certainty of evidence for incisional hernia and operative time was very low. The certainty of evidence for these outcomes was downgraded for inconsistency, indirectness, and the risk of performance and detection biases related to lack of blinding in the included RCTs.

Potential biases in the review process

We made every attempt to minimise the risk of selection bias in this review. We searched multiple electronic data resources using a sensitive search strategy, and two review authors independently conducted article screening, study selection, data collection, and analyses. Furthermore, we followed our preregistered protocol to minimise the risk of bias due to selective reporting in this review. Unfortunately, we included fewer than 10 RCTs so were unable to formally assess publication bias. Participant satisfaction (one of our primary outcomes) was poorly reported in the included RCTs, and the results of our meta‐analyses for this outcome may be subject to type 2 error.

We calculated the OR as the summary measure for dichotomous variables. The OR and risk ratio (RR) are recognised to be valid for measuring an intervention effect; we calculated ORs instead of RRs in this review solely because OR calculation is the normal practice of the review author team. However, we were mindful not to misinterpret ORs as RRs, the consequence of which would be overestimation of the intervention effect. Therefore, we believe that calculation of ORs instead of RRs did not induce any bias in this review.

The variation in stoma site skin closure techniques is unlikely to be associated with any other rare adverse outcomes not covered in this review. However, some of the evaluated adverse outcome parameters (e.g. anastomotic leak or intestinal obstruction) might have been under‐reported by some included RCTs, as these outcomes were rare and may not be directly relevant to the investigated interventions. This might have biased our findings in favour of one of the interventions.

Agreements and disagreements with other studies or reviews

Our findings are consistent with those of previous meta‐analyses (Gachabayov 2019; Hajibandeh 2018; Hsieh 2015; Rondelli 2018; Wu 2019). Gachabayov 2019 analysed 1812 participants from 20 studies (randomised and non‐randomised) and concluded that PSSC is associated with a lower risk of SSI in people undergoing loop ileostomy reversal. Wu 2019 included a meta‐analysis of nine RCTs (806 participants) and demonstrated significantly lower risk of SSI with PSSC versus LSC. We previously conducted a meta‐analysis of 14 studies (six RCTs and eight observational studies) in 1102 people and found a significantly lower risk of SSI amongst people who had PSSC compared with those who had LSC (Hajibandeh 2018). Trial sequential analysis suggested that the risk of type 1 error was minimal and meta‐analysis was conclusive (Hajibandeh 2018). The results of the other systematic reviews have been consistent with the above findings (Hsieh 2015; Rondelli 2018).

Consistent with the current review, our previous meta‐analysis showed no difference between the two skin closure techniques in terms of risks of incisional hernia, anastomotic leak, intestinal obstruction, operative time, and length of hospital stay. Moreover, we could not meta‐analyse data on participant satisfaction due to poor reporting of the outcome and heterogeneity amongst the available studies in terms of the scales used (Hajibandeh 2018).

Authors' conclusions

Implications for practice.

Purse‐string skin closure (PSSC) compared with linear skin closure (LSC) likely reduces the risk of surgical site infection in people undergoing reversal of stoma. People who have PSSC may be more satisfied with the result compared with people who have LSC. There may be little or no difference between the skin closure techniques in terms of incisional hernia and operative time, though the evidence is very uncertain for these two outcomes.

Implications for research.

There is a need to standardise measurement and reporting of participant satisfaction in future trials of PSSC versus LSC. Investigators should also assess the effects of PSSC versus LSC plus wound drain on surgical site infection and participant satisfaction, and compare the cost‐effectiveness of the two closure techniques.

History

Protocol first published: Issue 6, 2022

Appendices

Appendix 1. Glossary of terms

Terms	Meaning
Intestinal stoma	Surgically created intestinal opening on the surface of the abdomen
Ileostomy	Opening of small intestine on the surface of the abdomen
Colostomy	Opening of large intestine on the surface of the abdomen
Intestinal anastomosis	A surgically created connection between two formerly distant portions of the intestine
Inflammation	Complex biological response of body tissues to harmful stimuli
Malignancy	The state or presence of a malignant tumour; cancer
Hernia	Abnormal exit of tissue or an organ, such as the bowel, through the wall of the cavity in which it normally resides
Surgical site infection	Infection of wound after surgery
Anastomotic leak	Leakage of luminal contents from a surgical join or anastomosis
Secondary intention healing	The healing that occurs when a wound is left open to heal naturally
Seroma	A pocket of clear serous fluid that sometimes develops in the body after surgery
Morbidity	The frequency of complications as a result of a treatment or disease
Subcutaneous	Situated or applied under the skin

Appendix 2. Search strategy in Ovid MEDLINE (1946 to 21 December 2022)

Search No	Search Strategy
1	Surgical Stomas/
2	Ileostomy/
3	Colostomy/
4	ostom*.mp
5	MeSH Ostomy/
6	(Ileostom* or colostom* or stoma or stomas or ostom*).mp.
7	1 or 2 or 3 or 4 or 5 or 6
8	exp wound closure techniques/
9	(pursestring or purse).mp.
10	(sutur* adj3 techni*).mp.
11	((skin or stoma or stomas or stomata or stomatas or wound*) adj3 clos*).mp.
12	8 or 9 or 10 or 11
13	7 and 12

Appendix 3. Adjusted search strategy in CENTRAL (searched 21 December 2022)

Search No	Search strategy
#1	MeSH descriptor: [Surgical Stomas] explode all trees
#2	MeSH descriptor: [Ileostomy] explode all trees
#3	MeSH descriptor: [Colostomy] explode all trees
#4	MeSH descriptor: [Ostomy] explode all trees
#5	(Ileostom* or colostom* or stoma or stomas or ostom*):ti,ab,kw
#6	#1 or #2 or #3 or #4 or #5
#7	MeSH descriptor: [Wound Closure Techniques] explode all trees
#8	(pursestring or purse):ti,ab,kw
#9	((suture* or (wound next clos*) or (stoma next clos*)) NEAR/3 techni*):ti,ab,kw
#10	#7 or #8 or #9
#11	#6 and #10 in Trials

Appendix 4. Adjusted search strategy in Embase (1974 to 21 December 2022) and CINAHL EBSCOhost (1980 to 21 December 2022)

Search No	Search strategy
#1	purse‐string: TI,AB,KW
#2	purse string: TI,AB,KW
#3	#1 OR #2
#4	linear: TI,AB,KW
#5	conventional: TI,AB,KW,KW
#6	traditional: TI,AB,KW
#7	#4 OR #5 OR #6
#8	MeSH descriptor: [ileostomy] explode all trees
#9	ileostom*: TI,AB,KW
#10	MeSH descriptor: [colostomy] explode all trees
#11	colostom*: TI,AB,KW
#12	#8 OR #9 OR #10 OR #11
#13	#3 AND #7 AND #12
TI: Title; AB: Abstract; KW: Keyword

Appendix 5. Search terms used in trial databases (searched 21 December 2022)

Search terms

purse‐string stoma closure

purse‐string ileostomy closure

purse‐string colostomy closure

purse‐string ostomy closure

pursestring stoma closure

pursestring ileostomy closure

pursestring colostomy closure

pursestring ostomy closure

Data and analyses

Comparison 1. Purse‐string skin closure (PSSC) versus linear skin closure (LSC): all participants.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Surgical site infection	9	757	Odds Ratio (M‐H, Random, 95% CI)	0.17 [0.09, 0.29]
1.2 Participant satisfaction (very satisfied or satisfied)	2		Odds Ratio (M‐H, Random, 95% CI)	Subtotals only
1.2.1 Very satisfied	2	122	Odds Ratio (M‐H, Random, 95% CI)	4.32 [0.64, 29.23]
1.2.2 Satisfied	2	122	Odds Ratio (M‐H, Random, 95% CI)	0.39 [0.17, 0.88]
1.2.3 Satisfied or very satisfied	2	122	Odds Ratio (M‐H, Random, 95% CI)	20.11 [1.09, 369.88]
1.3 Participant satisfaction (unsatisfied or very unsatisfied)	2		Odds Ratio (M‐H, Random, 95% CI)	Subtotals only
1.3.1 Unsatisfied	2	122	Odds Ratio (M‐H, Random, 95% CI)	0.06 [0.00, 1.11]
1.3.2 Very unsatisfied	2	122	Odds Ratio (M‐H, Random, 95% CI)	0.31 [0.01, 7.97]
1.3.3 Unsatisfied or very unsatisfied	2	122	Odds Ratio (M‐H, Random, 95% CI)	0.05 [0.00, 0.91]
1.4 Incisional hernia	4	297	Odds Ratio (M‐H, Random, 95% CI)	0.51 [0.07, 3.70]
1.5 Anastomotic leak	3	213	Odds Ratio (M‐H, Random, 95% CI)	0.41 [0.06, 2.91]
1.6 Intestinal obstruction	2	145	Odds Ratio (M‐H, Random, 95% CI)	1.07 [0.40, 2.85]
1.7 Operative time (minutes)	6	460	Mean Difference (IV, Random, 95% CI)	‐2.67 [‐8.56, 3.22]
1.8 Length of hospital stay (days)	6	460	Mean Difference (IV, Random, 95% CI)	‐0.77 [‐1.77, 0.23]

Comparison 2. Purse‐string skin closure (PSSC) versus linear skin closure (LSC): participants with ileostomy.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Surgical site infection	5	344	Odds Ratio (M‐H, Random, 95% CI)	0.15 [0.07, 0.32]
2.2 Participant satisfaction (very satisfied or satisfied)	1		Odds Ratio (M‐H, Random, 95% CI)	Subtotals only
2.2.1 Very satisfied	1	61	Odds Ratio (M‐H, Random, 95% CI)	1.64 [0.50, 5.35]
2.2.2 Satisfied	1	61	Odds Ratio (M‐H, Random, 95% CI)	0.61 [0.19, 2.00]
2.2.3 Very satisfied or satisfied	1	61	Odds Ratio (M‐H, Random, 95% CI)	Not estimable
2.3 Participant satisfaction (unsatisfied or very unsatisfied)	1		Odds Ratio (M‐H, Random, 95% CI)	Subtotals only
2.3.1 Unsatisfied	1	61	Odds Ratio (M‐H, Random, 95% CI)	Not estimable
2.3.2 Very unsatisfied	1	61	Odds Ratio (M‐H, Random, 95% CI)	Not estimable
2.3.3 Unsatisfied or very unsatisfied	1	61	Odds Ratio (M‐H, Random, 95% CI)	Not estimable
2.4 Incisional hernia	2	156	Odds Ratio (M‐H, Random, 95% CI)	1.65 [0.11, 25.47]
2.5 Anastomotic leak	1	72	Odds Ratio (M‐H, Random, 95% CI)	Not estimable
2.6 Intestinal obstruction	1	84	Odds Ratio (M‐H, Random, 95% CI)	0.94 [0.30, 2.98]
2.7 Operative time (minutes)	5	344	Mean Difference (IV, Random, 95% CI)	‐2.24 [‐8.46, 3.99]
2.8 Length of hospital stay (days)	5	344	Mean Difference (IV, Random, 95% CI)	‐0.78 [‐1.87, 0.32]

Comparison 3. Purse‐string skin closure (PSSC) versus linear skin closure (LSC) plus wound drain.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Surgical site infection	1	159	Odds Ratio (M‐H, Random, 95% CI)	0.54 [0.15, 1.93]

3.1. Analysis.

Comparison 3: Purse‐string skin closure (PSSC) versus linear skin closure (LSC) plus wound drain, Outcome 1: Surgical site infection

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ali 2021.

Study characteristics
Methods	Design: parallel‐group RCT Study period: December 2017–December 2018
Participants	Setting: elective general or colorectal surgery Type of stoma: ileostomy Inclusion criteria Age ≥ 18 years Temporary stoma formation secondary to typhoid perforation Exclusion criteria Stoma formation for other pathologies Death or dropout Need for secondary surgery at other centres
Interventions	PSSC using subcuticular absorbable suture (n = 37) versus LSC using interrupted non‐absorbable suture (n = 35). No mesh or drain was used during closure in either group.
Outcomes	SSI (according to CDC diagnostic guidelines) Participant satisfaction (POSAS) at 1 month and 3 months Intestinal obstruction/leakage Hospital stay
Notes	The 2 groups were comparable in terms of baseline demographics (age, sex, BMI) and comorbidities. The length of follow‐up was 3 months. The study received no external funding, and the protocol had been registered with the Chinese Clinical Trial Registry (registration number: ChiCTR 1900025624). The study authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Article describes method of randomisation but not type of randomisation.
Allocation concealment (selection bias)	Low risk	The method used for randomisation supports allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded (blinding may not be practical in this setting).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessment was not blinded (blinding may not be practical in this setting).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete outcome data for all participants.
Selective reporting (reporting bias)	Low risk	No selective reporting detected.
Other bias	Low risk	No other sources of bias detected.

Alvandipour 2016.

Study characteristics
Methods	Design: parallel‐group RCT Study period: February 2015–May 2015
Participants	Setting: elective general or colorectal surgery Type of stoma: ileostomy Inclusion criteria Age ≥ 18 years Colorectal cancer Protective ileostomy after surgery Benign condition that required ileostomy Exclusion criteria Death or dropout Need for secondary surgery at other centres
Interventions	PSSC using subcuticular absorbable suture (n = 34) versus LSC using interrupted non‐absorbable suture (n = 32). No mesh or drain was used during closure in either group.
Outcomes	SSI (any infection of the superficial or deep tissues or the organ/space affected by the surgery when no prosthesis has been implanted) as identified by a surgeon in the outpatient clinic within 30 days of surgery Operating time Length of hospital stay Postoperative pain (VAS) at 3 days, 7 days, 1 month, and 3 months after surgery Participant satisfaction with the wound or scar (VAS) at 3 days, 7 days, 1 month, and 3 months after surgery
Notes	The 2 groups were comparable in terms of baseline demographics (age, sex, BMI) and comorbidities. The length of follow‐up was 3 months. The study received no external funding, and the protocol had been registered with the Iranian Registry of Clinical Trials (registration number: IRCT2015040714483N3). The study authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Article describes method of randomisation but not type of randomisation.
Allocation concealment (selection bias)	High risk	Method used for randomisation is not recognised to support allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded (blinding may not be practical in this setting).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessment was not blinded (blinding may not be practical in this setting).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete outcome data for all participants.
Selective reporting (reporting bias)	Low risk	No selective reporting detected.
Other bias	Low risk	No other sources of bias detected.

Amano 2019.

Study characteristics
Methods	Design: parallel‐group RCT Study period: November 2007–September 2016
Participants	Setting: elective general or colorectal surgery Type of stoma: ileostomy or colostomy Inclusion criteria Age ≥ 18 years Elective stoma reversal Ability to provide voluntary informed consent for participation Exclusion criteria Parastomal hernia requiring intensive repair Double stomas located close to each other Refusal to provide consent for participation in the trial
Interventions	PSSC using subcuticular absorbable suture (n = 89) versus LSC using interrupted non‐absorbable suture plus use of wound drain (n = 79). Wound drain was used in the LSC group but no mesh was used during closure in either group.
Outcomes	Wound healing 30 days after surgery SSI at the stoma site 30 days after surgery (diagnosed by the presence of erythema, pain, swelling or discharge at or around the stoma site
Notes	The 2 groups were comparable in terms of baseline demographics (age, sex, BMI) and comorbidities. The length of follow‐up was 1 month. The study received no external funding, and the protocol had been registered with University Hospital Medical Information Network (registration number: UMIN000030772). The study authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Method and type of randomisation described appropriately.
Allocation concealment (selection bias)	Low risk	Method used for randomisation supports allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded (blinding may not be practical in this setting).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessment was not blinded (blinding may not be practical in this setting).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete outcome data for all participants.
Selective reporting (reporting bias)	Low risk	No selective reporting detected.
Other bias	Low risk	No other sources of bias detected.

Camacho‐Mauries 2013.

Study characteristics
Methods	Design: parallel‐group RCT Study period: January 2010–February 2011
Participants	Setting: elective general or colorectal surgery Type of stoma: ileostomy or colostomy Inclusion criteria Age ≥ 18 years End or loop stoma Willingness to restore the intestinal tract Exclusion criteria Altered mental status Inability to answer the survey
Interventions	PSSC using subcuticular non‐absorbable suture (n = 31) versus LSC using interrupted non‐absorbable suture (n = 30). No mesh or drain was used during closure in either group.
Outcomes	SSI, defined as any superficial or deep infection in the surgical site that occurred between day 1 and day 30 of the postoperative period Participant satisfaction (Likert questionnaire) 6 months after surgery Postoperative pain (VAS) 6 months after surgery Cosmetic appearance of scar (VAS) 6 months after surgery Incisional hernia Anastomotic leak Intestinal obstruction Operative time Length of hospital stay
Notes	The 2 groups were comparable in terms of baseline demographics (age, sex, BMI) and comorbidities. The length of follow‐up was 12 months. The study received no external funding, but it was unclear whether the protocol had been registered. The study authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Article describes method of randomisation but not type of randomisation.
Allocation concealment (selection bias)	Low risk	Method used for randomisation supports allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded (blinding may not be practical in this setting).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessment was not blinded (blinding may not be practical in this setting).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete outcome data for all participants.
Selective reporting (reporting bias)	Unclear risk	Unclear if protocol was registered.
Other bias	Low risk	No other sources of bias detected.

Dusch 2013.

Study characteristics
Methods	Design: parallel‐group RCT Study period: January 2009–January 2011
Participants	Setting: elective general or colorectal surgery Type of stoma: ileostomy Inclusion criteria Age ≥ 18 years Indication for elective ileostomy closure Informed consent Expected patient compliance Exclusion criteria Participation in other trials
Interventions	PSSC using subcuticular non‐absorbable suture (n = 43) versus LSC using interrupted non‐absorbable suture (n = 41). No mesh or drain was used during closure in either group.
Outcomes	SSI according to CDC definition, within 30 days of operation Cosmetic outcome (POSAS and BIQ), 30 days and 6 months after operation Incisional hernia Intestinal obstruction Operative time Length of hospital stay
Notes	The 2 groups were comparable in terms of baseline demographics (age, sex, BMI) and comorbidities. The length of follow‐up was 6 months. The study received no external funding, and the protocol had been registered with the German Clinical Trials Register (registration number: DRKS00000073). The study authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Article describes method of randomisation but not type of randomisation.
Allocation concealment (selection bias)	Low risk	Method used for randomisation supports allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded (blinding may not be practical in this setting).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessment was not blinded (blinding may not be practical in this setting).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete outcome data for all participants.
Selective reporting (reporting bias)	Low risk	No selective reporting detected.
Other bias	Low risk	No other sources of bias detected.

Lee 2014.

Study characteristics
Methods	Design: parallel‐group RCT Study period: December 2008–August 2012
Participants	Setting: elective general or colorectal surgery Type of stoma: ileostomy or colostomy Inclusion criteria Age ≥ 18 years Colostomy or ileostomy appropriate for stoma reversal Exclusion criteria Protocol violations or insufficient follow‐up
Interventions	PSSC using subcuticular absorbable suture (n = 58) versus LSC using interrupted non‐absorbable suture (n = 55). No mesh or drain was used during closure in either group.
Outcomes	SSI within 30 days of surgery, according to CDC criteria Participant satisfaction with wound appearance on postoperative days 7 and 30 (5‐point Likert scale) Operative time Length of hospital stay
Notes	The 2 groups were comparable in terms of baseline demographics (age, sex, BMI) and comorbidities. The length of follow‐up was 1 month. The study received no external funding, and the protocol had been registered with ClinicalTrials.gov (registration number: NCT01713452). The study authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Method and type of randomisation described appropriately.
Allocation concealment (selection bias)	Low risk	Method used for randomisation supports allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded (blinding may not be practical in this setting).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessment was not blinded (blinding may not be practical in this setting).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete outcome data for all participants.
Selective reporting (reporting bias)	Low risk	No selective reporting detected.
Other bias	Low risk	No other sources of bias detected.

O'Leary 2017.

Study characteristics
Methods	Design: parallel‐group RCT Study period: February 2013–July 2015
Participants	Setting: elective general or colorectal surgery Type of stoma: ileostomy Inclusion criteria Age ≥ 18 years Ability to consent to undergo elective reversal of a loop ileostomy Exclusion criteria Any systemic immunosuppressive medication including steroids at the time of surgery
Interventions	PSSC using subcuticular absorbable suture (n = 34) versus LSC using continuous absorbable suture (n = 37). No mesh or drain was used during closure in either group.
Outcomes	SSI, according to CDC guidelines (superficial incisional SSI, deep incisional SSI, and organ/space SSI) Quality of life (Likert scale translated to a numerical scale) at 1 month and 6 months after surgery Operative time Length of hospital stay
Notes	The 2 groups were comparable in terms of baseline demographics (age, sex, BMI) and comorbidities. The length of follow‐up was 6 months. The source of external funding and registration of the protocol were unclear. The study authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Method and type of randomisation described appropriately.
Allocation concealment (selection bias)	Low risk	Method used for randomisation supports allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded (blinding may not be practical in this setting).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessment was not blinded (blinding may not be practical in this setting).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete outcome data for all participants.
Selective reporting (reporting bias)	Unclear risk	Unclear is protocol was registered.
Other bias	Unclear risk	Unclear source of external funding.

Reid 2010.

Study characteristics
Methods	Design: parallel‐group RCT Study period: November 2006–December 2007
Participants	Setting: elective general or colorectal surgery Type of stoma: ileostomy Inclusion criteria Age ≥ 18 years Exclusion criteria Language difficulties or impaired mental state
Interventions	PSSC using subcuticular non‐absorbable suture (n = 30) versus LSC using interrupted absorbable suture (n = 31). No mesh or drain was used during closure in either group.
Outcomes	SSI according to CDC criteria (any infection of the superficial or deep tissues or the organ/space affected by surgery, and which occurs within 30 days of surgery when no prosthesis has been implanted) Participant satisfaction (5‐point Likert scale), at least 12 months after surgery Operating time Length of hospital Postoperative pain (VAS) on postoperative days 1, 2, and 3 in hospital, at the point of hospital discharge, and 30 days after surgery
Notes	The 2 groups were comparable in terms of age, BMI, and comorbidities. There were more men in the LSC group. The length of follow‐up was 12 months. The study received no external funding, and the protocol had been registered with the Australian New Zealand Clinical Trials Registry (registration number: ACTRN12609000021279). The study authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Method and type of randomisation described appropriately.
Allocation concealment (selection bias)	Low risk	Method used for randomisation supports allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded (blinding may not be practical in this setting).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessment was not blinded (blinding may not be practical in this setting).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete outcome data for all participants.
Selective reporting (reporting bias)	Low risk	No selective reporting detected.
Other bias	Low risk	No other sources of bias detected.

Sureshkumar 2018.

Study characteristics
Methods	Design: parallel‐group RCT Study period: not reported
Participants	Setting: elective general or colorectal surgery Type of stoma: ileostomy or colostomy Inclusion criteria Age ≥ 12 years Exclusion criteria Unwillingness to participate
Interventions	PSSC using subcuticular absorbable suture (n = 40) versus LSC using interrupted non‐absorbable suture (n = 40). No mesh or drain was used during closure in either group.
Outcomes	SSI within 30 days of operation according to CDC criteria Participant satisfaction (Likert 5‐point scale) at 3 months' follow‐up Incisional hernia Anastomotic leak Operative time Length of hospital stay
Notes	The 2 groups were comparable in terms of baseline characteristics. The length of follow‐up was 3 months. The study received no external funding, but it was unclear whether the protocol had been registered. The study authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Method and type of randomisation described appropriately.
Allocation concealment (selection bias)	Low risk	Method used for randomisation supports allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded (blinding may not be practical in this setting).
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessment was not blinded (blinding may not be practical in this setting).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete outcome data for all participants.
Selective reporting (reporting bias)	Unclear risk	Unclear if protocol was registered.
Other bias	Low risk	No other sources of bias detected.

BIQ: Body Image Questionnaire; BMI: body mass index; CDC: Centres for Disease Control and Prevention; LSC: linear skin closure; n: number of participants; PSSC: purse‐string skin closure; POSAS: Patient and Observer Scar Assessment Scale; RCT: randomised controlled trial; SSI: surgical site infection; VAS: visual analogue scale.

Characteristics of studies awaiting classification [ordered by study ID]

Borsuk 2022.

Methods	Design: parallel‐group RCT Study period: October 2018–October 2022
Participants	People undergoing an ileostomy reversal Setting: elective general or colorectal surgery
Interventions	Primary linear closure with incisional negative pressure wound therapy versus purse‐string approximation
Outcomes	Wound healing time SSI
Notes	Preliminary results of this study suggested that primary linear closure with incisional negative pressure wound therapy may be a favourable alternative to purse‐string approximation. The article was a conference abstract with inadequate information about its methodology, interventions, and included population.

Carannante 2022.

Methods	Design: parallel‐group RCT Study period: not available
Participants	People undergoing ileostomy closure Setting: elective general or colorectal surgery
Interventions	Purse‐string closure (n = 50) versus direct closure (n = 50)
Outcomes	SSI Cosmetic outcomes
Notes	The results of the study suggested that purse‐string closure is associated with a lower risk of SSI. The article was a conference abstract with inadequate information about its methodology, interventions, and included population.

Carter 2016.

Methods	Design: parallel‐group RCT Study period: May 2013–July 2015
Participants	People undergoing ileostomy reversal Setting: elective general or colorectal surgery
Interventions	Primary linear closure (n = 27) versus purse‐string approximation (n = 34)
Outcomes	SSI Patient satisfaction Quality of life
Notes	The study showed significant decrease in SSI rates when purse‐string approximation was performed compared to primary linear closure. The article was a conference abstract with inadequate information about its methodology, interventions, and included population.

n: number of participants; RCT: randomised controlled trial; SSI: surgical site infection.

Differences between protocol and review

See Hajibandeh 2022 (protocol).

Although in the protocol we planned to use random‐effects or fixed‐effect modelling as appropriate depending on observed between‐study heterogeneity for analysis of each outcome, we only used random‐effects modelling in the review to account for inevitable heterogeneity associated with studies on surgical procedures.

We planned to measure participant satisfaction at one month, three months, and six months postoperatively by itemised questionnaires. However, owing to significant heterogeneity amongst the included studies in terms of the scales, the way the scales were used, and reporting of measurements, we synthesised and analysed participant satisfaction as a dichotomous outcome: the number of participants classed as very satisfied or satisfied and the number classed as unsatisfied or very unsatisfied (as reported in two studies). Consequently, we did not calculate the standardised mean difference (SMD).

We did not construct funnel plots to visually assess publication bias because no meta‐analyses included more than 10 studies.

The available data were inadequate to perform analyses for the following subgroups.

• Participants with colostomy

• Immunocompromised participants

Due to lack of data regarding timing of stoma closure in relation to adjuvant chemotherapy, we were unable to perform sensitivity analysis based on trials that evaluated stoma closure during adjuvant chemotherapy. Neither could we perform separate analyses for trials at low risk of bias in terms of blinding, as none were blinded.

Contributions of authors

Shahab H: conception, design, protocol, literature search, data collection, data analysis, writing, and final approval of the review
Shahin H: conception, design, protocol, literature search, data collection, data analysis, writing, and final approval of the review
AM: conception, design, protocol, literature search, data collection, data analysis, writing, and final approval of the review

Sources of support

Internal sources

• None, UK

  The study received no support from internal sources.

External sources

• None, UK

  The study received no support from external sources.

Declarations of interest

Shahab H: none known
Shahin H: none known
AM: none known

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