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

Recruiting now · Not applicable

Conditions studied: BRCA Mutation

In brief

The study hypothesis is that surgical treatment performed with MiniLap results in reduced postoperative pain in a population of patients undergoing prophylactic laparoscopic adnexal surgery. The primary objectives are to assess differences in operative duration, intraoperative blood loss, and postoperative complications in patients undergoing bilateral laparoscopic adnexectomy performed with standard laparoscopy versus MiniLap. The secondary objectives of this study are to compare postoperative pain and patient satisfaction with aesthetic outcomes. Patients with BRCA 1/2 mutations undergoing prophylactic surgery will be assigned to either MiniLap or standard laparoscopic treatment based on randomization. Subsequently, the necessary study data will be collected using the hospital's electronic management system and medical records.

Key facts

Study ID

NCT06831747

Run by

Azienda Sanitaria-Universitaria Integrata di Udine

People needed

80

Starts

2025-01-08

Expected to finish

2025-12-01

Last updated by the study team

2025-02-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.
• Patients with a germline mutation in the BRCA1/2 gene.

You may not qualify if…

• Patients who underwent additional surgery during the adnexectomy procedure.
• Patients in whom an intraoperative frozen section is required.

Where it is running

• Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine — Udine, Udine, Italy (enrolling)

Full record on ClinicalTrials.gov

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