Comparing MiniLap and Standard Laparoscopy for Preventive Surgery in BRCA-Mutated Patients
Official title: MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-Oophorectomy in BRCA-Mutated Patients: a Randomized Controlled Trial
Run by Azienda Sanitaria-Universitaria Integrata di Udine · NCT06831747 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | Azienda Sanitaria-Universitaria Integrata di Udine Academic / other |
| Locations | 1 site (Udine, Udine) |
| Status | Recruiting |
| Started | January 8, 2025 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | February 18, 2025 |
| Trial ID | NCT06831747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with BRCA1 or BRCA2 mutations who are planning to undergo prophylactic bilateral adnexectomy.
✕Probably not a fit
Patients who require additional surgeries during the adnexectomy or those needing intraoperative frozen sections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar studies have explored laparoscopic techniques, the specific comparison of MiniLap in this context is relatively novel.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.