A Study Comparing Single-Port and Multi-Port Robot-Assisted Surgery in Patients With Prostate or Kidney (Renal) Cancer
Starting soon
Conditions studied: Prostate Cancer, Renal Cancer
In brief
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.
Key facts
- Study ID
- NCT07610083
- Run by
- IRCCS San Raffaele
- People needed
- 376
- Starts
- 2026-06-01
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-05-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients < 18 years
- 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
- Contraindication to surgery
- Presence of distant metastases (M1)
Where it is running
- IRCCS Ospedale San Raffaele — Milan, Italy
Full record on ClinicalTrials.gov
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