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

Not Applicable

Recruiting

• Conditions: BRCA Mutation

• Registration Number: NCT06831747
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-08
• Study First Submitted: 2025-01-19
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-16
• Last Update Submitted: 2025-02-16
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification)	From enrollment to 30 days postoperatively	The primary objectives are to assess differences in: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification) in patients undergoing bilateral laparoscopic adnexectomy performed with standard laparoscopy versus MiniLap.

Secondary Outcome Measures

Name	Time	Method
Pain (Visual Analog Score)	From enrollment to 2 days postoperatively.	The secondary objective of this study is to compare postoperative pain (VAS 0-10; higher scores mean worse)
Cosmetic results (Visual Analog Score)	From enrollment to 60 days postoperatively.	The secondary objective of this study is to compare patient satisfaction with aesthetic outcomes using a VAS scale (0-10, with higher scores indicating greater satisfaction).

Trial Locations

Locations (1)

Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine; 🇮🇹 Udine, Italy