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

RecruitingNAAges 18 Years - anyFemaleAzienda Sanitaria-Universitaria Integrata di Udine
NCT06831747 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Bilateral salpingo-oophorectomy - S-LPS
  • Bilateral salpingo-oophorectomy - PSS
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Where

1 site
Department of Maternal and Child Health, Obstetrics and Gynecology Clinic, University Hospital of Udine
Udine, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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