Safety of Opportunistic Salpingectomy During Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
研究概览
简要总结
The knowledge, coupled with epidemiological studies demonstrating lower ovarian cancer rates in women with a history of tubal sterilization has led to recommendations for opportunistic salpingectomy at the time of benign gynecological surgery. However, this recommendation was not explored in the setting of non-gynecological surgeries, of most if the surgery performed not in pelvis.
This study aims to evaluate the safety of performing opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy in women aged 45 years or older. Of note, the only available prospective study from Austria evaluated feasibility of combined operation. By assessing complication rates and other perioperative outcomes, the study seeks to determine if this combined approach is a safe for opportunistic ovarian cancer prevention. Ultimately, this research may inform surgical practice and potentially reduce the incidence of ovarian cancer in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 45 years or older.
- •No known history of ovarian or fallopian tube cancer.
- •Completed family planning.
- •Scheduled to undergo elective laparoscopic cholecystectomy for benign gallbladder disease.
- •Able to provide informed consent.
- •Willing to comply with study procedures and follow-up assessments.
排除标准
- •Previous abdominal Surgery or any inflammatory bowel disease.
- •Current pregnancy or breastfeeding (verbally asked).
- •Contraindications to laparoscopic surgery (e.g., severe cardiopulmonary disease, extensive prior abdominal surgery).
- •Any medical condition that, in the opinion of the investigator, would preclude safe participation in the study or interfere with follow-up.
- •Participation in another clinical trial that may confound the results of this study.