NCT06891664

Feasibility of Day-surgery Management for Patients Undergoing Robotic Radical Prostatectomy: a Randomized Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To compare the day-surgery approach versus routine management in patients undergoing robotic radical prostatectomy, aimed at evaluating the feasibility of a one-day hospitalization regimen for robotic radical prostatectomy. The study will allow to evaluate the patients'compliance and subsequently investigate the safety, the impact on the patient's quality of life and on the healthcare costs resulting from day-surgery management of patients undergoing robotic radical prostatectomy.

Detailed description

The clinical study is aimed at evaluating the compliance of patients, candidates for robot-assisted radical prostatectomy for prostate cancer, to be enrolled in an RCT that provides for assignment to day surgery management (experimental arm) or ordinary management (control arm). The study involves the evaluation of the compliance of patients, candidates for robot-assisted radical prostatectomy for prostate cancer, to be enrolled in an RCT that provides for assignment to day surgery management (experimental arm) or ordinary management (control arm). The study will allow us to test a protocol for day-surgery management that includes all the clinical and technological measures at our disposal, including single-port robotic surgery and telemedicine. Using the experience and results obtained from this trial, it will then be possible to design a confirmatory multicenter RCT that compares day-surgery management vs ordinary management. The latter will then have the task of demonstrating with a high level of evidence that robotic radical prostatectomy can be performed safely in day-surgery, guaranteeing economic advantages to the facility while also favoring a more rapid recovery of the patient. Considering that approximately 20,000 radical prostatectomies are performed every year in Italy, this paradigm shift could guarantee a significant economic advantage. A transition of this type requires robust scientific evidence in order to convince doctors, patients and health systems to rely on a more efficient health model based on better management of resources.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Day surgery regimen for patients	The protocol includes admission on the evening of Day -1 and the execution of the surgery on the morning of Day 0 under general anesthesia. The surgery will be performed with the aid of the Da Vinci Single-port robotic system with extraperitoneal access.
OTHER	Ordinary management	Management of patients undergoing robotic radical prostatectomy in an inpatient setting based on a minimum of two nights of hospitalization

Timeline

• Start date: 2024-10-23
• Primary completion: 2027-05-23
• Completion: 2027-05-23
• First posted: 2025-03-24
• Last updated: 2025-03-24

Locations

1 site across 1 country: Italy