Evaluating complications after outpatient laparoscopic prostate surgery
Study of Postoperative Complications After Laparoscopic Outpatient Radical Prostatectomy in Patients With Localized Prostate Cancer
This study looks at the complications that may happen in the month after outpatient laparoscopic prostate surgery for men with localized prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05975775 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of surgery-related complications in patients undergoing outpatient laparoscopic radical prostatectomy for localized prostate cancer. It is a prospective, open-label, single-arm study conducted at two centers, focusing on the type, number, severity, duration, and frequency of complications occurring within the first month post-surgery. The decision to perform the procedure on an outpatient basis is made by the surgeon based on established medical criteria. Patient follow-up will occur during a routine visit one month after the surgery.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older with localized prostate cancer who are scheduled for laparoscopic radical prostatectomy and have been validated for curative treatment.
Not a fit: Patients who are not eligible for ambulatory care or have surgical emergencies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve patient safety and outcomes by identifying and minimizing complications associated with outpatient laparoscopic prostate surgery.
How similar studies have performed: Other studies have shown success with similar outpatient surgical approaches, indicating potential for positive outcomes in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lyon
- Clinique de la Sauvegarde — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Arnaud BALDINI, MD
- Email: docteur.baldini@urolyon-ouest.fr
- Phone: 469001019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.