• CattoJames W FJWFDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, England.Department of Urology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England.Division of Surgery and Interventional Science, University Col, Pramit Khetrapal, Federico Ricciardi, Gareth Ambler, Norman R Williams, Tarek Al-Hammouri, KhanMuhammad ShamimMSDepartment of Urology, Guys and St Thomas' NHS Foundation Trust, London, England., Ramesh Thurairaja, Rajesh Nair, Andrew Feber, Simon Dixon, Senthil Nathan, Tim Briggs, Ashwin Sridhar, Imran Ahmad, Jaimin Bhatt, Philip Charlesworth, Christopher Blick, Marcus G Cumberbatch, Syed A Hussain, Sanjeev Kotwal, Anthony Koupparis, John McGrath, Aidan P Noon, Edward Rowe, Nikhil Vasdev, Vishwanath Hanchanale, Daryl Hagan, Chris Brew-Graves, John D Kelly, and iROC Study Team.
• Department of Oncology and Metabolism, University of Sheffield, Sheffield, England.
• JAMA. 2022 Jun 7; 327 (21): 209221032092-2103.

ImportanceRobot-assisted radical cystectomy is being performed with increasing frequency, but it is unclear whether total intracorporeal surgery improves recovery compared with open radical cystectomy for bladder cancer.ObjectivesTo compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy.Design, Setting, And ParticipantsRandomized clinical trial of patients with nonmetastatic bladder cancer recruited at 9 sites in the UK, from March 2017-March 2020. Follow-up was conducted at 90 days, 6 months, and 12 months, with final follow-up on September 23, 2021.InterventionsParticipants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169).Main Outcomes And MeasuresThe primary outcome was the number of days alive and out of the hospital within 90 days of surgery. There were 20 secondary outcomes, including complications, quality of life, disability, stamina, activity levels, and survival. Analyses were adjusted for the type of diversion and center.ResultsAmong 338 randomized participants, 317 underwent radical cystectomy (mean age, 69 years; 67 women [21%]; 107 [34%] received neoadjuvant chemotherapy; 282 [89%] underwent ileal conduit reconstruction); the primary outcome was analyzed in 305 (96%). The median number of days alive and out of the hospital within 90 days of surgery was 82 (IQR, 76-84) for patients undergoing robotic surgery vs 80 (IQR, 72-83) for open surgery (adjusted difference, 2.2 days [95% CI, 0.50-3.85]; P = .01). Thromboembolic complications (1.9% vs 8.3%; difference, -6.5% [95% CI, -11.4% to -1.4%]) and wound complications (5.6% vs 16.0%; difference, -11.7% [95% CI, -18.6% to -4.6%]) were less common with robotic surgery than open surgery. Participants undergoing open surgery reported worse quality of life vs robotic surgery at 5 weeks (difference in mean European Quality of Life 5-Dimension, 5-Level instrument scores, -0.07 [95% CI, -0.11 to -0.03]; P = .003) and greater disability at 5 weeks (difference in World Health Organization Disability Assessment Schedule 2.0 scores, 0.48 [95% CI, 0.15-0.73]; P = .003) and at 12 weeks (difference in WHODAS 2.0 scores, 0.38 [95% CI, 0.09-0.68]; P = .01); the differences were not significant after 12 weeks. There were no statistically significant differences in cancer recurrence (29/161 [18%] vs 25/156 [16%] after robotic and open surgery, respectively) and overall mortality (23/161 [14.3%] vs 23/156 [14.7%]), respectively) at median follow-up of 18.4 months (IQR, 12.8-21.1).Conclusions And RelevanceAmong patients with nonmetastatic bladder cancer undergoing radical cystectomy, treatment with robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy resulted in a statistically significant increase in days alive and out of the hospital over 90 days. However, the clinical importance of these findings remains uncertain.Trial RegistrationISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410.

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