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: 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.

Study Overview

• Status: Recruiting
• Conditions: BRCA Mutation
• Intervention / Treatment: Procedure: Bilateral salpingo-oophorectomy - S-LPS; Procedure: Bilateral salpingo-oophorectomy - PSS

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Restaino; Phone Number: +390432559653; Email: stefano.restaino@asufc.sanita.fvg.it

Study Locations

• Italy
  • Udine, Italy, 33100
    • Recruiting
    • Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine
    • Contact: Stefano Restaino; Phone Number: +390432559653; Email: stefano.restaino@asufc.sanita.fvg.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A: Standard laparoscopy; Bilateral salpingo-oophorectomy performed with standard laparoscopy	Procedure: Bilateral salpingo-oophorectomy - S-LPS; In standard laparoscopy (S-LPS), the initial laparoscopic access was performed at the umbilical level using open laparoscopy (Hasson technique). The subsequent accesses were carried out in the right and left iliac fossa. In the S-LPS, these accesses are performed using a 5mm trocars. Finally, a 5mm ancillary trocar was placed in the suprapubic region to use instruments such as bipolar forceps, irrigators, and scissors. The subsequent surgical steps were identical for both techniques.
Experimental: B: MiniLap; Bilateral salpingo-oophorectomy performed with MiniLap	Procedure: Bilateral salpingo-oophorectomy - PSS; In the MiniLap® Percutaneous Surgical System (PSS), the initial laparoscopic access was performed at the umbilical level using open laparoscopy (Hasson technique). The subsequent two accesses were carried out in the right and left iliac fossa. These latter accesses are directly performed using MiniLap® with a 2.4mm incision. Finally, a 5mm ancillary trocar was placed in the suprapubic region to use instruments such as bipolar forceps, irrigators, and scissors. The subsequent surgical steps were identical for both techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification)	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.	From enrollment to 30 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain (Visual Analog Score)	The secondary objective of this study is to compare postoperative pain (VAS 0-10; higher scores mean worse)	From enrollment to 2 days postoperatively.
Cosmetic results (Visual Analog Score)	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).	From enrollment to 60 days postoperatively.

Collaborators and Investigators

• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: February 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Laparoscopy; BRCA mutations; MiniLap; Salpingo-Oophorectomy
• Other Study ID Numbers: 0022677

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No