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Trial Title:
Outpatient Laparoscopic Radical Prostatectomy
NCT ID:
NCT05975775
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic radical prostatectomy
Description:
Prostate cancer may require laparoscopic radical prostatectomy, a surgical procedure
performed under general anaesthetic.
Arm group label:
ambulatory patient cohort
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.
Criteria for eligibility:
Study pop:
This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic
radical prostatectomy has been validated at a multidisciplinary consultation meeting.
Ambulatory management is at the surgeon's discretion, according to well-defined medical
procedure criteria.
Sampling method:
Non-Probability Sample
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique de la Sauvegarde
Address:
City:
Lyon
Zip:
69009
Country:
France
Status:
Recruiting
Contact:
Last name:
Arnaud BALDINI, MD
Email:
docteur.baldini@urolyon-ouest.fr
Start date:
October 20, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Agency class:
Other
Source:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05975775
