Outpatient Laparoscopic Radical Prostatectomy

GCS Ramsay Santé pour l'Enseignement et la Recherche64 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Interventions

Laparoscopic radical prostatectomyPROCEDURE

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinique de la Sauvegarde

Lyon, France

RECRUITING

Outcomes

Primary Outcomes

Incidence of complications

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

Time frame: 30 days

Central Contacts

Arnaud BALDINI, MD

CONTACT

469001019 docteur.baldini@urolyon-ouest.fr

Data from ClinicalTrials.gov

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