Open Radical Cystectomy Versus Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Early Outcomes of a Single Center Randomised Controlled Trial

Introduction: 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. Methods: 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. Results: 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%vsORC: 41%; p=0.046). Conclusions: 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.