MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-Oophorectomy in BRCA-Mutated Patients: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.

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

Locations
Other Locations
Italy
Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine
RECRUITING
Udine
Contact Information
Primary
Stefano Restaino
stefano.restaino@asufc.sanita.fvg.it
+390432559653
Time Frame
Start Date: 2025-01-08
Estimated Completion Date: 2025-12
Participants
Target number of participants: 80
Treatments
Active_comparator: A: Standard laparoscopy
Bilateral salpingo-oophorectomy performed with standard laparoscopy
Experimental: B: MiniLap
Bilateral salpingo-oophorectomy performed with MiniLap
Sponsors
Leads: Azienda Sanitaria-Universitaria Integrata di Udine

This content was sourced from clinicaltrials.gov