IRCCS Ospedale San Raffaele
Milan, 20132, Italy
NCT Number: NCT07610083
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 opening soon.
Get Notified18 year and older
All sexes
Observational
Milan, 20132, Italy
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.
Additional secondary outcomes include functional outcomes after RARP (urinary continence, sexual function, and health-related quality of life), renal function after RAPN (estimated glomerular filtration rate), decision regret, and cosmetic satisfaction and body image perception.
All outcomes are collected prospectively according to predefined time points within routine follow-up schedules.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 30
Length of hospital stay (LOS), defined as the time from the end of surgery (skin closure) to hospital discharge, expressed in days or hours. Discharge will be based on predefined and standardized discharge criteria.
IRCCS San Raffaele
Other
Single-port vs. Multi-port Robot-assisted Surgery for Prostate or Renal Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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