Original Investigation May 15, 2022

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, et al

JAMA. Published online May 15, 2022. doi:10.1001/jama.2022.7393

Key Points

Question  Does robot-assisted surgery improve perioperative outcomes for patients undergoing radical cystectomy for bladder cancer?

Findings  In this randomized clinical trial that included 317 patients with nonmetastatic bladder cancer undergoing radical cystectomy, robot-assisted radical cystectomy with intracorporeal urinary diversion vs open radical cystectomy resulted in a median of 82 vs 80 days alive and out of the hospital within 90 days of surgery, a difference that was statistically significant.

Meaning  Robot-assisted surgery compared with open surgery for radical cystectomy among patients with bladder cancer resulted in a statistically significantly higher number of days alive and out of the hospital, but the clinical importance of this difference is uncertain.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