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

Abstract

Importance Robot-assistedradical cystectomy is being performed with increasing frequency, but it isunclear whether total intracorporeal surgery improves recovery compared withopen radical cystectomy for bladder cancer. Objectives To compare recovery and morbidity afterrobot-assisted radical cystectomy with intracorporeal reconstruction vs openradical cystectomy. Design,Setting, and Participants Randomizedclinical trial of patients with nonmetastatic bladder cancer recruited at 9sites in the UK, from March 2017-March 2020. Follow-up was conducted at 90days, 6 months, and 12 months, with final follow-up on September 23, 2021. Interventions Participants were randomized to receiverobot-assisted radical cystectomy with intracorporeal reconstruction (n = 169)or open radical cystectomy (n = 169). MainOutcomes and Measures Theprimary outcome was the number of days alive and out of the hospital within 90days of surgery. There were 20 secondary outcomes, including complications,quality of life, disability, stamina, activity levels, and survival. Analyseswere adjusted for the type of diversion and center. Results Among 338 randomized participants, 317 underwentradical cystectomy (mean age, 69 years; 67 women [21%]; 107 [34%] receivedneoadjuvant chemotherapy; 282 [89%] underwent ileal conduit reconstruction);the primary outcome was analyzed in 305 (96%). The median number of days aliveand out of the hospital within 90 days of surgery was 82 (IQR, 76-84) forpatients 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 roboticsurgery 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 2.0scores, 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 significantafter 12 weeks. There were no statistically significant differences in cancerrecurrence (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). Conclusionsand Relevance Among patients with nonmetastaticbladder cancer undergoing radical cystectomy, treatment with robot-assistedradical cystectomy with intracorporeal urinary diversion vs open radicalcystectomy resulted in a statistically significant increase in days alive andout of the hospital over 90 days. However, the clinical importance of thesefindings remains uncertain.