Outpatient Laparoscopic Radical Prostatectomy

NCT05975775 | Recruiting

• 1 other identifier: 2023-A00622-43
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of complications

  The primary endpoint was the incidence of procedural complications between Day 0 and Day 30.

  30 days

Study Arms (1)

ambulatory patient cohort

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

Procedure: Laparoscopic radical prostatectomy

Interventions

Laparoscopic radical prostatectomy PROCEDURE

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

ambulatory patient cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting. Ambulatory management is at the surgeon's discretion, according to well-defined medical procedure criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Arnaud BALDINI, MD

CONTACT

469001019; docteur.baldini@urolyon-ouest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 4, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

FR (1)