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NCT Number: NCT06831747

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

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.

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Key information

Conditions

BRCA Mutation

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Udine, 33100, Italy

Location status: Recruiting

Location contact

Stefano Restaino

CONTACT

[email protected]

+390432559653

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification)

    Time frame: From enrollment to 30 days postoperatively

    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.

Secondary outcomes

  1. Pain (Visual Analog Score)

    Time frame: From enrollment to 2 days postoperatively.

    The secondary objective of this study is to compare postoperative pain (VAS 0-10; higher scores mean worse)

  2. Cosmetic results (Visual Analog Score)

    Time frame: From enrollment to 60 days postoperatively.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Restaino

CONTACT

[email protected]

+390432559653

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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