LORP: Outpatient Laparoscopic Radical Prostatectomy
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate the incidence of surgery-related complications between Day 0 and Day 30.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Prostate cancer may require laparoscopic radical prostatectomy, a surgical procedure performed under general anaesthetic.
|
Outcome Measures
Primary Outcome Measures
- Incidence of complications [30 days]
The primary endpoint was the incidence of procedural complications between Day 0 and Day 30.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male, age ≥ 18 years;
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Localized prostate cancer;
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Validation in a multidisciplinary consultation meeting of curative treatment;
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Scheduled laparoscopic radical prostatectomy;
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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;
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Membership of a social security scheme;
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Patient having been informed and having given oral non-opposition.
Exclusion Criteria:
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Surgical emergency;
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Patient not eligible for ambulatory care;
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Long-term curative anti-coagulant treatment;
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Resident more than 100km from the clinic;
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Home alone the first night;
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Patient under guardianship, curatorship or deprivation of liberty.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique de la Sauvegarde | Lyon | France | 69009 |
Sponsors and Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-A00622-43