MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-oophorectomy in BRCA-Mutated Patients

Launched by AZIENDA SANITARIA-UNIVERSITARIA INTEGRATA DI UDINE · Feb 16, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two types of surgical approaches for women with BRCA mutations who are having a preventive surgery called bilateral salpingo-oophorectomy, which involves removing the ovaries and fallopian tubes to lower the risk of cancer. The study aims to find out if using a MiniLap technique leads to less pain after surgery compared to the standard laparoscopic method. Researchers will look at how long the surgery takes, how much blood is lost during the procedure, and any complications that arise afterward. They will also assess how much pain participants feel post-surgery and how satisfied they are with their surgical results.

Women aged 65 to 74 with BRCA 1 or 2 gene mutations who are planning to undergo this preventive surgery may qualify for the study. Participants will be randomly assigned to receive either the MiniLap or standard treatment. Throughout the trial, information about their surgeries and recovery will be collected through the hospital's electronic system. This study is currently recruiting participants, and those interested should discuss it with their healthcare provider to see if they meet the eligibility criteria.

Gender

FEMALE

Eligibility 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.