Clinical Trial

A Study Comparing Single-Port and Multi-Port Robot-Assisted Surgery in Patients With Prostate or Kidney (Renal) Cancer

Not Yet Recruiting
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Summary
This is a prospective single-center observational study comparing single-port (SP) and multi-port (MP) robot-assisted surgery in adult patients undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer. Consecutive eligible patients will be managed according to routine clinical practice and assigned to SP or MP surgery based on predefined clinical and anatomical criteria, surgeon assessment, patient and tumor characteristics, platform availability, and surgical expertise. No randomization will be performed. The study aims to compare perioperative outcomes between the two surgical approaches, with length of hospital stay (LOS) as the primary endpoint. Secondary endpoints include intraoperative outcomes (operative time, estimated blood loss, and intraoperative complications), postoperative recovery, pain, postoperative complications, readmission rates, positive surgical margins, and hospital costs. Functional and patient-reported outcomes will also be evaluated, including urinary continence, sexual function, health-related quality of life, renal function after partial nephrectomy, decision regret, and cosmetic satisfaction.
Trial Details
NCT Number NCT07610083
Lead Sponsor IRCCS San Raffaele
Conditions Prostate Cancer, Renal Cancer
Enrollment 376 participants
Start Date 2026-06
Primary Completion 2029-07 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-27