Six-month outcomes of a three-arm prospective study comparing Da Vinci vs. Hugo RAS vs. versius robotic radical prostatectomy: (the COMPAR-P trial)
摘要
To compare postoperative, oncological, and patient-reported outcomes of robot-assisted radical prostatectomy (RARP) performed with three CE-marked robotic platforms: Da Vinci Xi, Hugo RAS, and Versius. The COMPAR-P trial is a prospective, monocentric, post-market study conducted at the Azienda Ospedaliera Universitaria Integrata of Verona, Italy (ClinicalTrials.gov NCT05766163). From March 2023, 150 patients with organ-confined prostate cancer were consecutively enrolled and allocated to undergo RARP with Da Vinci Xi (n = 50), Hugo RAS (n = 50), or Versius (n = 50). Two high-volume robotic surgeons performed all procedures, experienced with Da Vinci but naïve to Hugo RAS and Versius before trial initiation. Surgical technique, perioperative protocols, and follow-up were standardized across cohorts. Outcomes at 6 months included serum PSA, complications (Clavien–Dindo classification), late sequelae (> 90 days), and health-related quality of life (SF-36 and UCLA-PCI questionnaires). Longitudinal analyses used linear mixed-effects models. Baseline demographics and disease characteristics were comparable across groups. At 6 months, PSA was undetectable in most patients, with no significant intergroup differences. Complication rates and late sequelae were low and evenly distributed. Questionnaire completion exceeded 90% at all time points. No significant long-term differences emerged in most SF-36 and UCLA-PCI domains. However, at 1 month, Hugo RAS and Versius patients reported lower Sexual Function scores than Da Vinci (–20 and − 28 points, respectively), and Versius patients reported lower Sexual Bother scores (–25 points, all p < 0.05). These differences disappeared at 3 and 6 months. Hugo RAS patients showed a temporary advantage in Physical Functioning at 1 month (+ 17 points vs. Da Vinci). Within the present study, and notwithstanding its inherent limitations, Da Vinci, Hugo RAS, and Versius achieved comparable safety, oncological, and short-term patient-reported outcomes in RARP. Early functional differences were transient and resolved over time. Surgical expertise, rather than the platform type, appears to be the primary determinant of outcomes.