Randomised controlled trials (RCTs) comparing open radical cystectomy (ORC) and robot-assisted RC (RARC) have involved an extracorporeal approach for urinary diversion (UD), undermining the potential benefits of a totally robotic procedure. Our objective was to compare 3-yr outcomes from a RCT comparing ORC to RARC with totally intracorporeal UD (iUD).
Patients with cT2-4 N0 M0 or bacillus Calmette-Guérin-failed high-grade non-muscle-invasive urothelial carcinoma who were candidates for RC without absolute contraindications to robotic surgery were included. A covariate adaptive randomisation process based on body mass index, American Society of Anesthesiologists score, preoperative haemoglobin, type of UD, neoadjuvant chemotherapy, and cT stage was used. The primary endpoint was to investigate the superiority of RARC with iUD in terms of a 50% reduction in transfusion rate. Secondary outcomes included adherence to an early recovery after surgery protocol, perioperative and postoperative outcomes, readmission and complication rates, a cost analysis, and functional, oncological, and health-related quality-of-life outcomes.
Overall, 116 patients were enrolled. The primary endpoint was confirmed, as the overall perioperative transfusion rate was significantly lower in the RARC cohort, with an absolute risk reduction of 19% (95% confidence interval 2-36%; p = 0.046). No differences in perioperative and postoperative complications and 3-yr oncological outcomes were observed between the groups. Despite the superiority of ORC on quantitative analysis of night-time pad use, there were no differences in the probabilities of recovery of daytime and night-time continence. Body image was significantly better in the RARC cohort. Cost analysis confirmed that RARC is a more expensive surgical procedure.
Our findings support RARC with iUD as a safe surgical option; the transfusion rate was reduced by 50% and the complication rates and 3-yr oncological outcomes were comparable to those with ORC. The minimally invasive nature of RARC was reflected in better body image perception in this cohort. The probabilities of daytime and night-time continence recovery were comparable between the groups. Higher costs remain a drawback of robotic surgery.
This RCT demonstrated a 50% transfusions rate's reduction compared to ORC. We confirmed safety and feasibility of RARC with i-UD providing comparable peri- and postoperative complication rates, as well as, 3yr oncologic outcomes to those of ORC. Patients receiving either RARC-iUD or ORC had comparable probabilities of urinary continence recovery after surgery.
European urology. 2024 Feb 08 [Epub ahead of print]
Riccardo Mastroianni, Gabriele Tuderti, Mariaconsiglia Ferriero, Umberto Anceschi, Alfredo Maria Bove, Aldo Brassetti, Simone D'Annunzio, Leonardo Misuraca, Giulia Torregiani, Marco Covotta, Salvatore Guaglianone, Michele Gallucci, Giuseppe Simone
Department of Urology, IRCCS Regina Elena National Cancer Institute, Rome, Italy. Electronic address: ., Department of Urology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.