<p>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 (&gt; 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 &lt; 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.</p>

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Six-month outcomes of a three-arm prospective study comparing Da Vinci vs. Hugo RAS vs. versius robotic radical prostatectomy: (the COMPAR-P trial)

  • Alessandro Antonelli,
  • Alessandro Veccia,
  • Sarah Malandra,
  • Vincenzo De Marco,
  • Riccardo Rizzetto,
  • Alessandra Gozzo,
  • Alberto Bianchi,
  • Matteo Brunelli,
  • Marianna Noale,
  • Maria Angela Cerruto,
  • Riccardo Bertolo,
  • Mariana Finocchiaro,
  • Luca Rahmati,
  • Mattia Ronca,
  • Michele Aloe,
  • Peres Fokana Pongmoni,
  • Andrea Franceschini,
  • Antonio Raiti,
  • Endri Toska,
  • Vincenzo Vetro,
  • Francesco Artoni,
  • Alberto Baielli,
  • Claudio Brancelli,
  • Sonia Costantino,
  • Piero Fracasso,
  • Francesca Fumanelli,
  • Francesca Montanaro,
  • Iolanda Palumbo,
  • Greta Pattenuzzo,
  • Luca Roggero,
  • Michele Boldini,
  • Davide Brusa,
  • Giovanni Corghi,
  • Lorenzo De Bon,
  • Francesco Ditonno,
  • Lorenzo Pierangelo Treccani

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.