Outpatient Laparoscopic Radical Prostatectomy

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Laparoscopic radical prostatectomy

• Registration Number: NCT05975775
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

The purpose of the study is to evaluate the incidence of surgery-related complications between Day 0 and Day 30.

Detailed Description

This is an observational, prospective, open, non-comparative (single arm), bicentric study.

This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting. The possibility of performing this procedure on an outpatient basis is left to the surgeon's discretion, according to well-defined medical procedure criteria.

This cohort is part of the usual care. The study will observe the incidence and describe the type, number, severity, duration and frequency of procedure-related complications that may arise in the first month post-op of ambulatory Laparoscopic Radical Prostatectomy. For this reason, patient follow-up will stop at 1 month after surgery, during a routine follow-up visit.

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-04
• Study Start: 2023-10-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• Male, age ≥ 18 years;
• Localized prostate cancer;
• Validation in a multidisciplinary consultation meeting of curative treatment;
• Scheduled laparoscopic radical prostatectomy;
• Patient able to understand the information related to the study, to read the information leaflet and to signify his/her non-opposition or opposition to participating in the study;
• Membership of a social security scheme;
• Patient having been informed and having given oral non-opposition.

Exclusion Criteria

• Surgical emergency;
• Patient not eligible for ambulatory care;
• Long-term curative anti-coagulant treatment;
• Resident more than 100km from the clinic;
• Home alone the first night;
• Patient under guardianship, curatorship or deprivation of liberty.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ambulatory patient cohort	Laparoscopic radical prostatectomy	Patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting.

Primary Outcome Measures

Name	Time	Method
Incidence of complications	30 days	The primary endpoint was the incidence of procedural complications between Day 0 and Day 30.

Trial Locations

Locations (1)

Clinique de la Sauvegarde; 🇫🇷 Lyon, France