Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

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 typeInterventional
Ages18 Years and up
SexWomen only
Enrollment80 (estimated)
SponsorAzienda Sanitaria-Universitaria Integrata di Udine
Academic / other
Locations1 site (Udine, Udine)
StatusRecruiting
StartedJanuary 8, 2025
Main results expectedDecember 2025
Study endsDecember 2025
Registry record updatedFebruary 18, 2025
Trial IDNCT06831747 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

  • Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine
    Udine, Udine, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.