Single-port vs. Multi-port Robot-assisted Surgery for Prostate or Renal Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 376
- Locations
- 1
Study Overview
Brief 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.
Detailed Description
This prospective observational cohort study is conducted at a single high-volume tertiary referral center performing robot-assisted urologic surgery using both single-port (SP) and multi-port (MP) robotic platforms.
The study includes consecutive adult patients (≥18 years) undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer during the study period.
Treatment allocation is not randomized. The choice between SP and MP surgery is made in routine clinical practice by the treating surgeon based on predefined clinical and anatomical criteria, including patient characteristics, tumor features, surgical indication, platform availability, and surgeon experience.
The primary objective is to compare perioperative outcomes between SP and MP robotic-assisted surgery, with length of hospital stay (LOS) defined as the primary endpoint. LOS is measured from the end of surgery (skin closure) to hospital discharge according to standardized discharge criteria.
Secondary outcomes include intraoperative parameters (operative time, estimated blood loss, intraoperative complications), postoperative recovery assessed by validated measures, pain scores, postoperative complications graded by Clavien-Dindo classification, readmission rates, positive surgical margins, and total hospital-related costs.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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)
Arms & Interventions
Multi-Port Robot-Assisted Surgery
Single-Port Robot-Assisted Surgery
Investigators
Francesco Montorsi
Professor and Chairman
IRCCS San Raffaele