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

Azienda Sanitaria-Universitaria Integrata di Udine

Status: Enrolling

Conditions: BRCA Mutation

Treatments: Procedure: Bilateral salpingo-oophorectomy - PSS; Procedure: Bilateral salpingo-oophorectomy - S-LPS

Study type: Interventional

Funder types: Other

Identifiers

NCT06831747

0022677

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

A: Standard laparoscopy

Active Comparator group

Description:

Bilateral salpingo-oophorectomy performed with standard laparoscopy

Treatment:

Procedure: Bilateral salpingo-oophorectomy - S-LPS

B: MiniLap

Experimental group

Description:

Bilateral salpingo-oophorectomy performed with MiniLap

Treatment:

Procedure: Bilateral salpingo-oophorectomy - PSS