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

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 8, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
BRCA Mutation
Interventions
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.

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.

Trial Locations (1)

33100

RECRUITING

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

All Listed Sponsors
lead

Azienda Sanitaria-Universitaria Integrata di Udine

OTHER