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

Official title

MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-Oophorectomy in BRCA-Mutated Patients: a Randomized Controlled Trial

Overview

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.

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

Primary outcome measures

• Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification) [Time frame: From enrollment to 30 days postoperatively]

Secondary outcome measures (2)

• Pain (Visual Analog Score) [Time frame: From enrollment to 2 days postoperatively.]
• Cosmetic results (Visual Analog Score) [Time frame: From enrollment to 60 days postoperatively.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hosp — Udine

Identifiers

NCT: NCT06831747 · 0022677

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗