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NCT07610083

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

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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.

Official title: Single-port vs. Multi-port Robot-assisted Surgery for Prostate or Renal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

376

Start Date

2026-06

Completion Date

2030-06

Last Updated

2026-05-27

Healthy Volunteers

No

Locations (1)

IRCCS Ospedale San Raffaele

Milan, Italy