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

NCT06831747 | Recruiting

• 1 other identifier: 0022677
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

BRCA Mutation

Keywords

Laparoscopy; BRCA mutations; Salpingo-Oophorectomy; MiniLap

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain (Visual Analog Score)

  From enrollment to 2 days postoperatively.

• Cosmetic results (Visual Analog Score)

  From enrollment to 60 days postoperatively.

Study Arms (2)

A: Standard laparoscopy

ACTIVE COMPARATOR

Bilateral salpingo-oophorectomy performed with standard laparoscopy

Procedure: Bilateral salpingo-oophorectomy - S-LPS

B: MiniLap

EXPERIMENTAL

Bilateral salpingo-oophorectomy performed with MiniLap

Procedure: Bilateral salpingo-oophorectomy - PSS

Interventions

Bilateral salpingo-oophorectomy - S-LPS PROCEDURE

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.

A: Standard laparoscopy

Bilateral salpingo-oophorectomy - PSS PROCEDURE

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.

B: MiniLap

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.
• Patients with a germline mutation in the BRCA1/2 gene.

You may not qualify if:

• Patients who underwent additional surgery during the adnexectomy procedure.
• Patients in whom an intraoperative frozen section is required.

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (1)

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

Udine, Udine, 33100, Italy

RECRUITING

Central Study Contacts

Stefano Restaino

CONTACT

+390432559653; stefano.restaino@asufc.sanita.fvg.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 18, 2025
• Study Start: January 8, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

IT (1)