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

Last updated: February 16, 2025
Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Bilateral salpingo-oophorectomy - S-LPS

Bilateral salpingo-oophorectomy - PSS

Clinical Study ID

NCT06831747
0022677
  • Ages > 18
  • Female

Study Summary

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.

  • Patients with a germline mutation in the BRCA1/2 gene.

Exclusion

Exclusion Criteria:

  • Patients who underwent additional surgery during the adnexectomy procedure.

  • Patients in whom an intraoperative frozen section is required.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Bilateral salpingo-oophorectomy - S-LPS
Phase:
Study Start date:
January 08, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

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

    Udine, 33100
    Italy

    Active - Recruiting

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