Outpatient Laparoscopic Radical Prostatectomy

NCT ID: NCT05975775

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2025-12-31

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ambulatory patient cohort

Patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting.

Laparoscopic radical prostatectomy

Intervention Type: PROCEDURE

Prostate cancer may require laparoscopic radical prostatectomy, a surgical procedure performed under general anaesthetic.

Interventions

Laparoscopic radical prostatectomy

Prostate cancer may require laparoscopic radical prostatectomy, a surgical procedure performed under general anaesthetic.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique de la Sauvegarde

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Arnaud BALDINI, MD

Role: CONTACT

docteur.baldini@urolyon-ouest.fr

469001019 ext. +33

Facility Contacts

Arnaud BALDINI, MD

Role: primary

docteur.baldini@urolyon-ouest.fr

Other Identifiers

2023-A00622-43

Identifier Type: -

Identifier Source: org_study_id