Naik 2010.

Study characteristics
Methods	Comparative phase II randomised controlled trial
Participants	15 women with histologically confirmed early‐stage 1B cervical cancer requiring radical surgical treatment 8 of the 15 women with early‐stage cervical cancer were randomised to LARVH and 7 women to RAH Median age for LARVH group was 38.5 years (IQR: 33.5 to 53.5) and 37 years for the RAH group (IQR: 29.5 to 46) Mean BMI in the LARVH group was 24.8 (SD 1.3) and 25 in the RAH group (SD 1.8) Median parity in the LARVH group was 2 (IQR: 1 to 3) and 2 in the RAH group (IQR: 1 to 2) 12 (92%) women had diagnostic LLETZ 2 (15%) women had lympho‐vascular space involvement Smoking status was 5 (38%) women were smokers and 8 (62%) women were non‐smokers The tumour histological type was adenocarcinoma in 2 (15%) women and squamous cell carcinoma in 11 (85%) women The mean lateral tumour size was 1.2 cm (SD 0.3 cm) in the LARVH group and 1.4 cm (SD 0.2 cm) in the RAH group The mean depth of invasion was 5.6 mm (SD 1.2 mm) in the LARVH group and 5.8 mm (SD 1.1 mm) in the RAH group There was no statistically significant difference between the 2 groups with respect to any of the reported baseline characteristics
Interventions	Intervention: LARVH: LARVH is performed using a viewing instrument (laparoscope) and other surgical instruments inserted through a number of small abdominal incisions. Laparoscopic lymph node dissection is followed by dissection of the uterus and surrounding tissues. Rest of the operation is carried out vaginally and the specimens are removed from the body through the vagina (Dargent 2000) Comparison: RAH: RAH involves removal of the cervix, uterus (womb) and supporting tissues (parametrium), together with the pelvic lymph nodes and a cuff of vagina. The operation is performed via an open or abdominal approach, utilising either a midline subumbilical or a transverse suprapubic incision (Lopes 1995) All women received intraoperative broad‐spectrum antibiotics for the duration of their surgery. Deep vein thrombosis prophylaxis was via perioperative subcutaneous low‐molecular‐weight heparin and intraoperative pneumatic calf compression garments. All women received morphine (1 mg/mL) via a patient‐controlled analgesia system for the first 24 hours postoperatively and oral analgesia thereafter
Outcomes	Requirement in days for bladder catheterisation after surgery Operating time Blood loss Hospital stay Opiate pain relief Complication rate Time to normal activities Resection size of major ligaments and vaginal cuff
Notes	15 women were recruited to the study over a 20‐month period. The trial was stopped at the end of the funding period because extension would not increase the precision of the estimated differences There were 2 exclusions after randomisation. 1 woman in the LARVH arm declined her allocation, exited the trial and defaulted to standard treatment. 1 woman in the RAH arm had her surgery abandoned before hysterectomy could be performed because a synchronous bowel tumour with multiple liver metastases was discovered intraoperatively In the group assigned to laparoscopic surgery, there was 1 intraoperative conversion to the open procedure (14%) because of an enterotomy. After examination under anaesthetic, another woman was found to have a cervical defect (because of previous conisation) potentially compromising the vaginal part of the procedure and the decision for open surgery was made Statistically significant differences (P value < 0.05) were found for the following when LARVH was compared with RAH: the median duration of catheterisation, median operating time, median blood loss, median hospital stay and median opiate requirement in the first 36 hours postoperatively There were 2 intraoperative complications in the LARVH group ‐ 1 enterotomy requiring conversion to the open procedure and 1 cystotomy, which was repaired vaginally. Neither woman suffered any long‐term sequelae Postoperative complications encountered were minor. 1 woman was readmitted to hospital after 32 days with severe constipation after RAH
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The participants underwent a 1:1 randomisation to either laparoscopic or standard open surgery using computer‐generated block randomisation"
Allocation concealment (selection bias)	Low risk	"The block size was four and this information was not known to the researchers until the trial had closed"
Blinding (performance bias and detection bias) All outcomes	Unclear risk	It was not reported whether the outcome assessors were blinded to all outcomes but they were blinded to the randomisation allocation of the women who completed the BBUSQ‐22
Incomplete outcome data (attrition bias) All outcomes	Low risk	% analysed: 13/15 (87%)
Selective reporting (reporting bias)	Low risk	Scope of trial was short‐term effects so it is unlikely any outcomes were selectively reported. Survival outcomes were not reported as these are long‐term outcomes
Other bias	Unclear risk	Insufficient information to assess whether an additional risk of bias exists

BBUSQ‐22: Bowel and Urinary Symptoms Questionnaire 22‐item inventory; BMI: body mass index; IQR: interquartile range; LARVH: laparoscopic assisted radical vaginal hysterectomy; LLETZ: large loop excision of the transformation zone; RAH: radical abdominal hysterectomy; SD: standard deviation.