Comparing MiniLap and Standard Laparoscopy for Preventive Surgery in BRCA-Mutated Patients
MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-Oophorectomy in BRCA-Mutated Patients: a Randomized Controlled Trial
This study tests whether a smaller surgical technique called MiniLap is better than standard laparoscopy for patients with BRCA mutations who are having preventive surgery to remove their ovaries and fallopian tubes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Azienda Sanitaria-Universitaria Integrata di Udine Academic / other |
| Locations | 1 site (Udine, Udine) |
| Trial ID | NCT06831747 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of MiniLap compared to standard laparoscopy in patients with BRCA mutations undergoing prophylactic bilateral salpingo-oophorectomy. The primary focus is on evaluating differences in operative duration, blood loss, and postoperative complications between the two surgical techniques. Additionally, the study aims to assess postoperative pain levels and patient satisfaction regarding aesthetic outcomes. Patients will be randomly assigned to either surgical approach, and data will be collected through the hospital's electronic management system.
Who should consider this trial
Good fit: Ideal candidates are patients with BRCA1 or BRCA2 mutations who are planning to undergo prophylactic bilateral adnexectomy.
Not a fit: Patients who require additional surgeries during the adnexectomy or those needing intraoperative frozen sections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced postoperative pain and improved recovery experiences for patients undergoing preventive surgery.
How similar studies have performed: While similar studies have explored laparoscopic techniques, the specific comparison of MiniLap in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery. * Patients with a germline mutation in the BRCA1/2 gene. Exclusion Criteria: * Patients who underwent additional surgery during the adnexectomy procedure. * Patients in whom an intraoperative frozen section is required.
Where this trial is running
Udine, Udine
- Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine — Udine, Udine, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Restaino
- Email: stefano.restaino@asufc.sanita.fvg.it
- Phone: +390432559653
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.