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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05975775
Other study ID # 2023-A00622-43
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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