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.
To compare recovery and morbidity after robot-assisted radical cystectomy with intracorporeal reconstruction vs open radical cystectomy.
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.
Participants were randomized to receive robot-assisted radical cystectomy with intracorporeal reconstruction (n = 169) or open radical cystectomy (n = 169).
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.
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).
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.
ISRCTN Identifier: ISRCTN13680280; ClinicalTrials.gov Identifier: NCT03049410.
JAMA. 2022 Jun 07 [Epub]
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
Department of Oncology and Metabolism, University of Sheffield, Sheffield, England., Division of Surgery and Interventional Science, University College London, London, England., Owlstone Medical, Cambridge, England., Department of Statistical Science, University College London, London, England., Surgical and Interventional Trials Unit (SITU), Division of Surgery and Interventional Science, University College London, London, England., Department of Urology, Guys and St Thomas' NHS Foundation Trust, London, England., Health Economics and Decision Science, NIHR Research Design Service Yorkshire and the Humber, University of Sheffield, Sheffield, England., Queen Elizabeth University Hospital, Glasgow, Scotland., The Harold Hopkins Department of Urology, Royal Berkshire NHS Foundation Trust, Reading, England., Pyrah Department of Urology, St James University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, England., Department of Urology, North Bristol NHS Trust, Bristol, England., Department of Urology, Royal Devon University Hospitals Foundation Trust and University of Exeter, Exeter, England., Department of Urology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England., Hertfordshire and Bedfordshire Urological Cancer Centre, Lister Hospital, University of Hertfordshire, Hatfield, England., Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, England.