Outpatient Laparoscopic Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic radical prostatectomy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of Postoperative Complications After Laparoscopic Outpatient Radical Prostatectomy in Patients With Localized Prostate Cancer
Overview
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.
Interventions
- Procedure Laparoscopic radical prostatectomy
Prostate cancer may require laparoscopic radical prostatectomy, a surgical procedure performed under general anaesthetic.
Primary outcome measures
- Incidence of complications [Time frame: 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Clinique de la Sauvegarde — Lyon
Identifiers
NCT: NCT05975775 · 2023-A00622-43