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-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.

Figure 1.. Participant Flow in the iROC Trial

^aReasons for not undergoing any cystectomy in the robotic cystectomy group: disease progression prior to cystectomy (n = 4), received radiotherapy (n = 2), and unknown reasons (n = 2). ^bReasons for undergoing open cystectomy in the robotic cystectomy group: surgeon not trained in robotic cystectomy (n = 1), waiting list issue (n = 1), conversion to open surgery (n = 1). ^cThis patient received robotic surgery outside the study. ^dReasons for not undergoing any cystectomy in the open cystectomy group: disease progression prior to cystectomy (n = 4), patient opted for another choice (n = 4), received radiotherapy (n = 1), and unknown reasons (n = 4). ^eReasons for undergoing robotic cystectomy in the open cystectomy group: patient opted for another choice (n = 3), surgeon decision (n = 1), advanced-stage disease (n = 1), nephrectomy (n = 1), and anesthesiologist decision (n = 1).

Figure 2.. Distribution of Days Alive and Out of the Hospital Within 90 Days of Surgery According to Group

As shown by the vertical dotted lines, the median number of days patients were alive and out of the hospital was 82 (IQR, 76-84) days for robotic radical cystectomy and 80 (IQR, 72-83) days for open radical cystectomy (P = .01 by linear regression, adjusted for site and reconstruction).

Figure 3.. Secondary Outcomes After Radical Cystectomy

Self-reported health-related quality of life instruments were (A) the European Quality of Life 5-Dimension, 5-Level (EQ-5D-5L; range, 0-1) and (B) the European Organisation for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30; range, 0-100). For both, higher scores indicate greater quality of life. Statistically significantly better health-related quality of life was seen with robotic surgery at 5 weeks on the EQ-5D-5L (P = .003) and at 5 weeks (P < .001) and 12 weeks (P = .01) on the EORTC QLQ-C30. Self-reported disability was measured using (C) the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 (range, 0-100), for which higher scores indicate greater disability. The open surgery group had statistically significantly more disability at 5 weeks (P = .003) and 12 weeks (P = .01). Wrist-based activity trackers recorded steps per day; findings are presented as (D) mean over 7 days and (E) maximum within 24 hours over 7 days (no statistically significant differences). Strength and stamina were measured using (F) a 30-second chair-to-stand test. The robotic surgery group had statistically significantly more stands in 30 seconds at 5 weeks (P = .03) and 12 weeks (P = .03). Participants with completed outcomes are shown. Horizontal lines in the middle of each box indicate medians; borders of each box, 25th and 75th percentiles; whiskers, the further point within 1.5× the IQR; and circles, points beyond the whiskers.

Figure 4.. Bladder Cancer Recurrence and All-Cause Mortality Following Radical Cystectomy, Stratified by Group

No statistically significant difference was seen in rates of bladder cancer recurrence (P = .70) and all-cause mortality (P = .80), plotted using the Kaplan-Meier method. Hazard ratios from the Cox regression model are shown. The median follow-up was 18.3 (IQR, 12.4-26.4) months for robotic radical cystectomy and 18.38 (IQR, 12.5-28.0) months for open radical cystectomy.