Early Postoperative Outcomes with the Toumai^® Surgical System for Robot-Assisted Radical Prostatectomy: A Prospective...

Background: Prostate cancer (PCa) imposes a substantial global health burden, with robot-assisted radical prostatectomy (RARP) established as the gold standard for localized disease. While da Vinci^® Xi maintains market dominance, Toumai^® MT-1000 offers a potentially cost-competitive alternative lacking prospective validation. Objective: To evaluate perioperative safety, oncologic quality (primary endpoint: positive surgical margins), early functional recovery (continence), and surgeon learning curve between Toumai^® MT-1000 (T-RARP) and da Vinci^® Xi RARP (DV-RARP) performed in high-volume European practice. Materials and Methods: This is a prospective single-center comparative study carried out at Policlinico Gemelli, Rome (May-November 2025), enrolling 80 patients with localized or locally advanced PCa, elected for radical prostatectomy and casually allocated to receive surgery with Toumai or the da Vinci robotic platform. The primary endpoint was the comparison of positive surgical margin (PSM) rates. Secondary endpoints included the comparison of operative time (skin-to-skin), estimated blood loss, length of hospital stay, 45-day postop outcomes, specifically Clavien-Dindo complications, urinary continence recovery (0-1 pad/day), and IIEF-5 scores. Learning curve was evaluated through the cumulative summation (CUSUM) analysis of operative times and linear regression of operative times (n = 80 cases). The analyses used STATA 19 with two-sided tests at p < 0.05 significance. Results: Baseline characteristics showed balance between cohorts (p > 0.05 for most covariates). Perioperative outcomes proved equivalent: median operative time (OT) was 192.5 min (IQR 165-230) for Toumai^® versus 183.5 min (IQR 147-225) for da Vinci^® Xi (p = 0.38); estimated blood loss (EBL) was 150 mL in both groups (p = 0.87); length of hospital stay (LOS) was 2 days in both groups (p = 0.92). PSM rates were identical at 17.5% (p = 0.79). Continence recovery reached 72.5% versus 80% (p = 0.43). Complications (Clavien-Dindo ≥ II) occurred in 7.5% versus 12.5% of cases (p = 0.45). The CUSUM analysis demonstrated operative time proficiency after only four procedures; operative time regression showed no significant trend (p = 0.38). Conclusions: Toumai^® MT-1000 demonstrates similar performance to da Vinci^® Xi across different RARP quality metrics, with no detectable learning curve for surgeons previously experienced with da Vinci. These findings support a safe integration of cost-effective platforms into clinical practice, pending multicenter randomized confirmation.