MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-Oophorectomy in BRCA-Mutated Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.
- •Patients with a germline mutation in the BRCA1/2 gene.
排除标准
- •Patients who underwent additional surgery during the adnexectomy procedure.
- •Patients in whom an intraoperative frozen section is required.
结局指标
主要结局
Perioperative outcomes: operative time (minutes), intraoperative blood loss (mL), postoperative complications (clavien dindo classification)
时间窗: 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.
次要结局
- Pain (Visual Analog Score)(From enrollment to 2 days postoperatively.)
- Cosmetic results (Visual Analog Score)(From enrollment to 60 days postoperatively.)
研究者
Stefano Restaino
Doctor
Azienda Sanitaria-Universitaria Integrata di Udine