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NCT07610083Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
376 (estimated)
First submitted
20 May 2026
Start date
Nov 2026
Primary completion date
Nov 2029
Lead sponsor
IRCCS San Raffaele
NCT number
NCT07610083

What you commit to

  • Study type: Observational
  • Planned participants: 376
  • From Nov 2026 to the primary completion date, Nov 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication to surgery

Age

  • Patients \< 18 years

Other

  • Mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
  • Inability to read and sign the informed consent
  • No available pre-operative staging
  • Presence of distant metastases (M1)

Who the study is looking for

  • The participant provides written informed consent
  • Male or female participants who are at least 18 years of age on the day of signing informed consent
  • Men with a diagnosis of prostate or renal cancer and women with a diagnosis of renal cancer
  • Pre-operative imaging performed for staging purposes (i.e. CT scan, PSMA PET) showing no suspicious evidence of distant metastases in prostate or renal cancer patients
  • Suitable for RARP or RAPN.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.