Bochner 2015.

Methods	Study design: parallel RCT, expertise‐based, superiority trial Study date: March 2010 to March 2013 Study setting: hospital‐based, single‐institution study –Memorial Sloan Kettering Cancer Center (MSKCC), USA Randomisation ratio: 1:1 Study hypothesised that the rate of Clavien grade 2 to 5 complications would be 20% lower in absolute terms for RARC compared with ORC. This trial with an α of 5% and 80% power would require 93 participants per arm. However, due to a mandated interim analysis to occur halfway through enrolment, the study intended to accrue 105 participants per arm to maintain 80% power. For the interim analysis, study authors would calculate the upper bound of a one‐sided 95% CI for the difference in rate of Clavien grade 2 to 5 complications between surgery groups. If the upper bound was 20%, they would stop the trial for futility.
Participants	Adults undergoing radical cystectomy (n = 118) Diagnostic criteria: Bladder cancer with clinical stage Ta–T3/N0–3/M0 Inclusion criteria: Medically cleared for RC plus PLND Aged 18 years Clinical stage Ta–T3/N0–3/M0 Exclusion criteria: Previous pelvic radiation Clinical stage T4 or M1 Any contraindication for Trendelenburg position, or extensive prior abdominal surgery Demographic data: RARC vs ORC Median age years (IQR) = 66 (60 to 71) vs 65 (58 to 69) Male sex, n (%) = 51 (85) vs 42 (72) Body mass index, kg/m², median (IQR) = 27.9 (24.7 to 31.0) vs 29.0 (26.3 to 33.7)
Interventions	Cohort 1 = ORC with urinary diversion and PLND (n = 58) Cohort 2 = RARC with extracorporeal urinary diversion and PLND (n = 60) Men underwent removal of the prostate if present, and women underwent hysterectomy and bilateral salpingo‐oophorectomy if organs were present. Lymphadenectomy template: The extent of the PLND was left to the discretion of the surgeon based on clinician preference and judgement (extent of disease, vascular disease) and was determined before randomisation. The extent of PLND was alterable intraoperatively based on clinical findings (vascular disease, fibrosis, adenopathy). Surgeon experience: This is an expertise‐based study. All RARC procedures were performed by 1 of 3 surgeons with extensive robotic pelvic surgery experience. All urinary diversions were performed as open surgeries; therefore, 1 of the surgeons experienced in open procedures completed them, regardless of the randomisation arm. All surgeons were urological oncology fellowship trained and had a minimum of 10 years’ operative experience in practice after fellowship. Number of conversions from RARC to ORC: 0 Number of participant crossovers to ORC after randomising to RARC: 4 (patient refusal to have RARC)
Outcomes	Primary outcomes Overall 90‐day grade 2 to 5 complications defined by a modified Clavien system Secondary outcomes included Comparison of high‐grade complications Estimated blood loss Operative time Pathological outcomes 3‐ and 6‐month patient‐reported QoL outcomes Total operative room and inpatient costs ITT analysis performed
Funding sources	This study was supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan Kettering Cancer Center, Pin Down Bladder Cancer, and the Michael and Zena Wienerfor Therapeutics Program in Bladder Cancer. Study sponsors were involved in the design and conduct of the study; in collection, analysis, management, and interpretation of the data; and in preparation, review, and approval of the manuscript.
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: "Consenting patients were stratified by age (64 vs 65 yr) and American Society of Anesthesiologists score (1–2 vs 3–4), then randomly assigned 1:1 to undergo RARC or ORC using randomly permuted blocks of random length." Comment: adequate random sequence generation performed
Allocation concealment (selection bias)	Low risk	Quote from publication: "Randomization was conducted by an independent office, where allocation concealment was ensured by a password‐protected database, such that the randomization group could not be predicted prior to receiving group assignment and group could not be changed after randomization." Comment: adequate allocation concealment
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: Trial does not explicitly state who collected these data.
Blinding of outcome assessment (detection bias) QOL	High risk	Comment: participant‐reported outcomes; participants not blinded
Blinding of outcome assessment (detection bias) Complications	High risk	Quote from publication: "All complications were graded on the MSKCC modified Clavien grading scale. Complications data were collected prospectively by unblinded MSKCC research study staff at the initial postoperative, 3‐mo, and 6‐mo follow‐up visits using the institution’s standard reporting method for postoperative complications." Comment: assessor unblinded
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	Quote from publication: "All pathologic specimens were reviewed blinded to surgical technique." Comment: adequate blinding; additionally, regardless of blinding, low risk of detection bias
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: "Fifty‐eight patients returned evaluable baseline surveys and 53 returned follow‐up surveys at 3 and 6 mo." Comment: In the RARC group, 60 participants were randomised, and 30 (50%) participants returned surveys at 6 months. In the ORC group, 58 participants were randomised, and 22 (38%) participants returned surveys at 6 months.
Incomplete outcome data (attrition bias) Recurrence Free Survival	Low risk	Comment: All randomised participants were included in the analysis.
Selective reporting (reporting bias)	Low risk	All predefined outcomes were reported for both groups in the time period suggested.
Other bias	Low risk	Comment: not detected