Salpingectomy in Women Undergoing Elective Laparoscopic Cholecystectomy (SaLCHE): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomy
研究概览
简要总结
Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of serous ovarian cancer. This study explores the acceptability and feasibility of opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy (LCHE).
详细描述
Many serous ovarian cancers are now thought to originate in the fimbria of the fallopian tubes. This has led a number of professional societies worldwide to recommend consideration of prophylactic salpingectomy at the time of elective gynecologic surgery or tubal sterilization.
This study explores the acceptability and feasibility of incidental (opportunistic, risk-reducing, prophylactic) salpingectomy at the time of a common nongynecologic procedure in women, i.e. elective laparoscopic cholecystectomy (LCHE). The study addresses whether women ≥45 years would accept opportunistic salpingectomy and the technical feasibility (time, port placement, complications) in women who consented to salpingectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Scheduled (elective) laparoscopic cholecystectomy for a benign indication
- •Age >45 years
排除标准
- •Age <45 years
- •Desire to preserve fertility
- •Cholecystectomy for malignant disease
- •Extensive previous abdominal surgery
研究组 & 干预措施
Salpingectomy
Opportunistic salpingectomy at the time of laparoscopic cholecystectomy
干预措施: Salpingectomy (Procedure)
结局指标
主要结局
Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomy
时间窗: At time of laparoscopic cholecystectomy surgery
Evaluation of how often opportunistic bilateral salpingectomy can be accomplished at the time of laparoscopic cholecystectomy
次要结局
- Time(At the time of surgery)
- Port repositioning(At surgery)
- Complications(30 days)
- Patient-recorded outcome(Preop. and 1 year)