Radical Cystectomy (RC) with urinary diversion (UD) is still considered a complex surgery associated with significant morbidity. Open RC (ORC) remains the reference option of treatment, even if adoption of robot-assisted RC (RARC) is rapidly increasing. To date, all the available RCTs were characterized by an extracorporeal approach in performing UD, undermining potential benefits of a totally minimally invasive procedure. In this study, we aimed to report perioperative and 6-months (mo) outcomes from the first RCT comparing ORC and RARC with totally intracorporeal (i) UD.
Patients were eligible for randomization if they had a diagnostic TURBt with cT2-4, cN0, cM0, or recurrent high-grade non-muscle invasive bladder cancer and no anesthesiologic contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomization process based on the following variables: BMI, ASA score, baseline haemoglobin, planned UD, neoadjuvant chemotherapy and cT-stage. Primary endpoint was to demonstrate the superiority of RARC with i-UD in terms of a 50% transfusions rate's reduction.
Overall, 116 consecutive patients (58 RARC, 58 ORC) were enrolled. Among primary endpoint, overall perioperative transfusion rates were significantly lower in the RARC cohort (RARC: 22% vs ORC: 41%; p=0.046).
This prospective randomized trial observed 22% and 41% overall perioperative transfusion rates in RARC- and ORC-treated patients, respectively, confirming a significant benefit in favour to RARC with i-UD. However, perioperative complications, hospital stay, and 6-mo HRQoL were largely comparable between groups. Oncologic and functional outcomes will be assessed at longer follow-up to observe potential differences between arms.
The Journal of urology. 2022 Jan 05 [Epub ahead of print]
Riccardo Mastroianni, Mariaconsiglia Ferriero, Gabriele Tuderti, Umberto Anceschi, Alfredo Maria Bove, Aldo Brassetti, Leonardo Misuraca, Ashanti Zampa, Giulia Torregiani, Edoardo Ghiani, Diana Giannarelli, Salvatore Guaglianone, Michele Gallucci, Giuseppe Simone
IRCCS "Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy., IRCCS "Regina Elena" National Cancer Institute, Department of Clinical Trial Centre, Biostatistics and Bioinformatics, Rome, Italy.