Outpatient Laparoscopic Radical Prostatectomy

Prostate Cancer Clinical Trial

— LORP  

Official title:

Study of Postoperative Complications After Laparoscopic Outpatient Radical Prostatectomy in Patients With Localized Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975775
• Other study ID #: 2023-A00622-43
• Status: Recruiting
• Start date: October 20, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Arnaud BALDINI, MD
• Phone: 469001019
• Email: docteur.baldini[@]urolyon-ouest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Clinique de la Sauvegarde	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complications	The primary endpoint was the incidence of procedural complications between Day 0 and Day 30.	30 days