Effect of Robot-Assisted Radical Cystectomy With Intracorporeal Urinary Diversion vs Open Radical Cystectomy on 90-Day Morbidity and Mortality Among Patients With Bladder Cancer: A Randomized Clinical Trial
James W F Catto, Pramit Khetrapal, Federico Ricciardi, Gareth Ambler, Norman R Williams, Tarek Al-Hammouri, Muhammad Shamim Khan, 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, iROC Study Team, E Ruth Groves, Louise Goodwin, Jayne Willson, Phillip Ravencroft, Stephen Kennish, Derek J Rosario, Carol Torrington, Rajesh Nair, Ramesh Thurairaja, Sue Amery, Kathryn Chatterton, Samantha Broadhead, David Hendry, Abdullah Zreik, Sunjay Jain, Steve Prescott, Hannah Roberts, Angela Morgan, Chris Main, Elspeth Bedford, Lorraine Wiseman, Bernice Mpofu, Claire Daisey, Michelle Donachie, Jon Aning, Lyndsey Johnson, Carol Brain, Constance Shiridzinomwa, Martin Ebon, Alexander Hampson, Roisin Schimmel, Scott Horsley, Sayyida Nembhard, Clare Collins, Jemma Gilmore, Faith Wilson, Louise Peacock, Sheena Lim, Rhosyll Gabriel, Rachael Sarpong, Melanie Tan, James W F Catto, Pramit Khetrapal, Federico Ricciardi, Gareth Ambler, Norman R Williams, Tarek Al-Hammouri, Muhammad Shamim Khan, 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, iROC Study Team, E Ruth Groves, Louise Goodwin, Jayne Willson, Phillip Ravencroft, Stephen Kennish, Derek J Rosario, Carol Torrington, Rajesh Nair, Ramesh Thurairaja, Sue Amery, Kathryn Chatterton, Samantha Broadhead, David Hendry, Abdullah Zreik, Sunjay Jain, Steve Prescott, Hannah Roberts, Angela Morgan, Chris Main, Elspeth Bedford, Lorraine Wiseman, Bernice Mpofu, Claire Daisey, Michelle Donachie, Jon Aning, Lyndsey Johnson, Carol Brain, Constance Shiridzinomwa, Martin Ebon, Alexander Hampson, Roisin Schimmel, Scott Horsley, Sayyida Nembhard, Clare Collins, Jemma Gilmore, Faith Wilson, Louise Peacock, Sheena Lim, Rhosyll Gabriel, Rachael Sarpong, Melanie Tan
Abstract
Importance: Robot-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.
Objectives: To compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy.
Design, setting, and participants: Randomized 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.
Interventions: Participants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169).
Main outcomes and measures: The 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.
Results: Among 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 relevance: Among 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 registration: ISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410.
Conflict of interest statement
Conflict of Interest Disclosures: Dr Catto reported receiving reimbursement for consultancy from AstraZeneca, Ferring, Roche, and Janssen; speaker fees from Bristol Myers Squibb, Merck Sharp & Dohme, Janssen, Astellas, Nucleix, and Roche; honoraria for membership in advisory boards from Ferring, Roche, Gilead, Photocure, Bristol Myers Squibb, QED Therapeutics, and Janssen; and research funding from Roche. Mr Sridhar reported receiving research funding and payment for proctorship from Intuitive Surgical. Dr Ahmad reported receiving payment for proctorship from Intuitive Surgical. Dr Hussain reported receiving reimbursement for consultancy from Pierre Fabre, Bayer, Janssen Oncology, Roche, Merck, Bristol Myers Squibb, AstraZeneca, Pfizer, Astellas, and GlaxoSmithKline; research funding from Cancer Research UK, the Medical Research Council/National Institute for Health and Care Research (NIHR), Boehringer Ingelheim, Roche, Janssen-Cilag, and Pierre Fabre; support for attending meetings and/or travel from Janssen-Cilag, Bayer, Boehringer Ingelheim, Pierre Fabre, Pfizer, Roche, Bristol Myers Squibb, AstraZeneca, and Merck Sharp & Dohme Oncology. Dr Koupparis reported receiving payment for proctorship from Intuitive Surgical. Dr McGrath reported receiving educational funding from Intuitive Surgical. Dr Noon reported receiving financial support for travel from Intuitive Surgical. No other disclosures were reported.
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Source: PubMed