Parekh 2013.

Methods	Study design: pilot prospective RCT Study date: July 2009 to June 2011 Study setting: single‐institution study–University of Texas Health Sciences Center at San Antonio, San Antonio, Texas, USA Pilot trial to establish Feasibility and safety of the robotic approach Preliminary data to determine statistical analyses and outcome measures for a phase 3 multi‐institutional clinical trial
Participants	Adults undergoing radical cystectomy (n = 40) Diagnostic criteria: Biopsy‐proven bladder cancer of clinical stage T1‐T3, N0, M0 Inclusion criteria: Candidates for an open or robotic approach at the discretion of the treating surgeon Exclusion criteria: Inability to give informed consent Multiple prior abdominal and pelvic open surgical procedures that would preclude a safe robotic approach Morbid obesity that would preclude the robotic approach Clinical T4 bladder cancer Clinical lymph node‐positive bladder cancer with grossly enlarged pelvic or retroperitoneal lymph nodes Any preexisting condition that precludes safe initiation or maintenance of pneumoperitoneum for a prolonged period Age younger than 30 or older than 90 years Pregnancy Demographic data: RARC vs ORC Median age years (IQR) = 69.5 (62.3 to 74) vs 64.5 (59.8 to 72.3) Male:Female = 18:2 vs 16:4 Body mass index, kg/m², median (IQR) = 27.6 (24.2 to 29.9) vs 28.3 (26.1 to 32.3)
Interventions	Cohort 1 = ORC with urinary diversion and PLND (n = 20) Cohort 2 = RARC with open urinary diversion and PLND (n = 20) The type of urinary diversion was performed at the discretion of the surgeon. The study does not explicitly state if the urinary diversion was performed with an extracorporeal or intracorporeal approach. Lymphadenectomy template: Lymph node dissection for both groups was performed superiorly to the level of the ureteral crossing of the common iliac vessels, including the internal iliac artery and the obturator fossa, and laterally to the genitofemoral nerve, including the tissue overlying the psoas muscle. Surgeon experience: The primary faculty involved in the study had an independent experience of more than 100 ORCs and had performed approximately 50 RARCs. Number of conversions from RARC to ORC: 0 Number of participant cross‐overs to ORC after randomising to RARC: 0
Outcomes	Establish the feasibility of randomising participants Obtain preliminary data on oncological efficacy, perioperative outcomes, and HRQoL outcomes Evaluate HRQoL using the FACT–VCI questionnaire preoperatively, and then at 3, 6, 9, and 12 months postoperatively
Funding sources	Not reported in the study
Declarations of interest	None
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "Patients who met the inclusion criteria were randomized to open or robotic radical cystectomy at their preoperative clinic visit using a computerized randomization program (www.randomization.com) (see figure). This program generated a list of surgical slots numbered 1 through 60, and randomly assigned open or robotic assisted cystectomy to each slot (30 slots for each procedure)." Comment: random sequence generation adequate
Allocation concealment (selection bias)	Low risk	Quote from publication: "Each assignment was placed in a sealed envelope with the corresponding slot number written on the outside. At the time of consent the lowest numbered envelope remaining was opened and the patient was assigned to the surgical procedure listed on the piece of paper inside the envelope." 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: "The surgical team and the patient were then made aware of the type of surgery." Comment: Participants were aware of the approach they had; hence there would have been an expectation bias when they completed their QoL questionnaires. Participant‐reported outcomes. Participants not blinded.
Blinding of outcome assessment (detection bias) Complications	Unclear risk	Comment: The study does not state who the outcome assessor was; it is unclear if the assessor was blinded.
Blinding of outcome assessment (detection bias) Transfusion Rates	Low risk	Comment: unlikely to be affected by nonblinding
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: Most randomised participants were included in the analysis for these outcomes.
Incomplete outcome data (attrition bias) QOL	High risk	Quote from second publication: "The study is limited by the response rate to the questionnaires, with sampling at only 50% for some time periods, which only underscores the difficulty of obtaining prospective data with regard to HRQoL." Comment: Reported in the second publication. In the RARC group, 20 participants were randomised, and 12 (60%) participants returned surveys at 12 months. In the ORC group, 20 participants were randomised, and 13 (65%) participants returned surveys at 12 months.
Incomplete outcome data (attrition bias) Recurrence Free Survival	Unclear risk	Comment: not reported
Selective reporting (reporting bias)	Low risk	All predefined outcomes measured
Other bias	Low risk	None