Khan 2016.

Methods	Study design: randomised controlled 3‐arm parallel‐group, expertise‐based, superiority trial Study date: March 2009 to July 2012 Study setting: hospital setting –Guy’s Hospital, London, UK Study authors estimated the RARC complication rate as 10% to 15% and the ORC complication rate as 25% to 60%. Therefore, the number needed in each arm ranges from 43 to 58, so the 95% CI for the estimated difference in rates is 16%. Based on these considerations, researchers aimed to recruit 47 participants per arm. A 3‐year interim analysis suggests no significant differences in primary outcomes between arms, and, coupled with recruitment difficulties, the institutional research project steering board recommended terminating the trial at that point.
Participants	Adults undergoing radical cystectomy (n = 60) Diagnostic criteria: MIBC and high‐risk NMIBC Inclusion criteria: Participants between 18 and 80 years of age requiring RC for MIBC or high‐risk NMIBC Exclusion criteria: Unsuitable for laparoscopic radical cystectomy or robotic‐assisted radical cystectomy due to severe cardiorespiratory comorbidities Extensive abdominopelvic surgery or radiation Demographic data: RARC vs ORC Mean age years (SD) = 68.6 (6.8) vs 66.6 (8.8) Male sex, n (%) = 17 (85) vs 18 (90) Body mass index, kg/m², mean (SD) = 27.5 (4.2) vs 27.4 (3.9)
Interventions	Cohort 1 = ORC with urinary diversion and PLND (n = 20) Cohort 2 = RARC with extracorporeal urinary diversion and PLND (n = 20) Cohort 3 = LRC with extracorporeal urinary diversion and PLND (n = 20) All neobladders were fashioned using the Studer technique. Lymphadenectomy template: obturator, external/internal/common iliac, and presacral nodes Surgeon experience: This is an expertise‐based study. At trial initiation, the ORC surgeon had performed > 150 ORCs and the RARC surgeon had performed 110 RARCs. Number of conversions from RARC to ORC: 0 Number of participant cross‐overs to ORC after randomising to RARC: 1 (equipment failure)
Outcomes	Primary end points 30‐ and 90‐day complication rates Secondary end points Perioperative parameters (operative time, EBL, delay in bowel function, and LOS) Pathological outcomes (margin status and number of lymph nodes retrieved) 12‐month oncological outcomes QoL –study authors do not state in the methodology when they plan to assess
Funding sources	The research, including statistical support (Jennifer A. Summers and Janet L. Peacock), was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre, based at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London. Prokar Dasgupta and Kamran Ahmed acknowledge support from the NIHR Biomedical Research Centre, Medical Research Council Centre for Transplantation, King’s Health Partners, Guy’s and St. Thomas’ Charity, School of Surgery, London Deanery, Royal College of Surgeons of England, Intuitive Surgical, The Urology Foundation, Olympus, EU‐FP7, ProstateCancer UK, Technology Strategy Board, and The Vattikuti Foundation.
Declarations of interest	None
Notes	Language of publication: English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "Randomisation was undertaken by the trial nurse (J.W.) using identical sealed opaque envelopes, each containing a piece of paper designating the surgical modality (ORC, LRC, or RARC). Simple randomisation was performed in two groups of 30. In each group, each modality was allocated 10 envelopes. These were shuffled and then numbered 1–30. Patients received the next envelope in numerical order." Comment: random sequence generation adequate
Allocation concealment (selection bias)	Low risk	Quote from publication: "Envelopes were kept in a locked room, accessed only by the trial nurse to minimise opportunities for tampering, and they were opened by the patient in the presence of three members of the research team to ensure that no changes were made to allocation." Comment: allocation concealment adequate
Blinding of participants and personnel (performance bias)	High risk	Comment: participants and personnel not blinded
Blinding of outcome assessment (detection bias) Recurrence Free Survival	Unclear risk	Comment: not reported
Blinding of outcome assessment (detection bias) QOL	High risk	Quote from publication: "This study was nonblinded because the different incisions would be difficult to camouflage." Comment: participant‐reported outcomes; participants not blinded
Blinding of outcome assessment (detection bias) Complications	High risk	Quote from publication: "This study was nonblinded because the different incisions would be difficult to camouflage." Comment: no outcome assessor blinding; study does not report the assessor
Blinding of outcome assessment (detection bias) Transfusion Rates	Unclear risk	Comment: not reported
Blinding of outcome assessment (detection bias) Hospital Stay	Low risk	Comment: unlikely to be affected by nonblinding
Blinding of outcome assessment (detection bias) Positive Margin Rates	Low risk	Comment: unlikely to be affected by nonblinding
Incomplete outcome data (attrition bias) Complications/Transfusion/Hospital Stay/Positive Margins	Low risk	Comment: All randomised participants were included in the analysis for these outcomes.
Incomplete outcome data (attrition bias) QOL	High risk	Quote from publication: "Overall, 53 patients completed the QoL questionnaire. One questionnaire was analysed per patient (average 8 mo postoperatively). Incomplete questionnaires were excluded." Comment: In the RARC group, 20 participants were randomised, and 15 (75%) participants returned surveys. In the ORC group, 20 participants were randomised, and 16 (80%) participants returned surveys.
Incomplete outcome data (attrition bias) Recurrence Free Survival	Unclear risk	Comment: not reported
Selective reporting (reporting bias)	Low risk	Comment: predefined outcomes reported for both groups in the time period suggested
Other bias	Low risk	Comment: not detected