Study of Postoperative Complications After Laparoscopic Outpatient Radical Prostatectomy in Patients With Localized Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Incidence of complications
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Incidence of complications
Time Frame: 30 days
The primary endpoint was the incidence of procedural complications between Day 0 and Day 30.