Outpatient Laparoscopic Radical Prostatectomy (LORP)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Laparoscopic radical prostatectomy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05975775

2023-A00622-43

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

64 participants in 1 patient group

ambulatory patient cohort

Description:

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

Treatment:

Procedure: Laparoscopic radical prostatectomy