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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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

Первичные конечные точки

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

Вторичные конечные точки (2)

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

Критерии участия

Критерии включения

• Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.
• Patients with a germline mutation in the BRCA1/2 gene.

Критерии исключения

• Patients who underwent additional surgery during the adnexectomy procedure.
• Patients in whom an intraoperative frozen section is required.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

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

Идентификаторы

NCT: NCT06831747 · 0022677

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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