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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

Eligibility

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.

Study details
    BRCA Mutation

NCT06831747

Azienda Sanitaria-Universitaria Integrata di Udine

15 October 2025

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