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MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-Oophorectomy in BRCA-Mutated Patients: a Randomized Controlled Trial
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine
Udine, Udine, Italy
Start Date
January 8, 2025
Primary Completion Date
December 1, 2025
Completion Date
December 1, 2025
Last Updated
February 18, 2025
80
ESTIMATED participants
Bilateral salpingo-oophorectomy - S-LPS
PROCEDURE
Bilateral salpingo-oophorectomy - PSS
PROCEDURE
Lead Sponsor
Azienda Sanitaria-Universitaria Integrata di Udine
NCT06666270
NCT06470685
Data Source & Attribution
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