Status:
Completed
Clinicaltrials.gov identifier:
Sponsor:
University College, London
Enrollment:
339
Study Design:
Prospective, multicenter randomized controlled trial randomizing patients undergoing radical cystectomy (1 : 1) to either intracorporeal robot-assisted radical cystectomy (iRARC) or open radical cystectomy (ORC) to assess recovery and morbidity.
Rationale:
Although robot-assisted laparoscopic radical cystectomy with extracorporeal urinary diversion has been shown to be non-inferior to open radical cystectomy, it is unknown how a totally intracorporeal or robot-assisted laparoscopic urinary diversion will affect outcomes. Therefore, this trial compares intracorporeal robot-assisted radical cystectomy with radical cystectomy in terms of recovery and days in the hospital.
Endpoints:
The primary endpoint was to compare the number of days alive and out of hospital within 90 days from surgery. The secondary endpoints were numerous and included: recovery, complications, quality of life, survival, disability, stamina, activity levels, and the return to normal activities.
Comments:
There is a small statistically significant increase in days alive and out of the hospital with iRARC compared to open surgery. However, results may not be generalizable as the study was undertaken in high volume centers with surgeons with expertise in robotic surgery. In addition, the study took place during the COVID-19 pandemic and closed early so that may have affected some endpoints. It may be that in order for robotic surgery to be potentially better than open surgery, a totally intracorporeal approach may need to be employed.
Results:
A total of 338 patients were randomized and 306 patients ultimately underwent radical cystectomy (157 had iRARC and 149 had ORC). Most patients had an ileal conduit diversion (89%). The median number of days alive and out of the hospital within 90 days of surgery was 82 (IQR: 76-84) for patients undergoing iRARC vs. 80 (IQR: 72-83) for patients undergoing ORC (adjusted difference, 2.2 days [95% CI, 0.50-3.85]; P = .01). Thromboembolic and wound complications were less common with robotic surgery than open surgery. There were no statistically significant differences in cancer recurrence and overall mortality at median follow-up of 18.4 months.
