Opportunistic Salpingectomy at the Time of Cesarean Delivery: A Randomized Controlled Trial of the Safety of Salpingectomy vs Tubal Ligation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)
研究概览
简要总结
The purpose of this study is to compare the safety of performing a bilateral tubal ligation vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the time of cesarean delivery. The investigators want to determine if performing bilateral salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as compared to a bilateral tubal ligation.
详细描述
A non-inferiority, two-arm randomized controlled trial to evaluate the safety and feasibility of prophylactic salpingectomy at the time of a cesarean delivery will be conducted as an initiative to avoid a missed opportunity in the primary prevention of ovarian cancer. Once enrolled and consented, women will be randomized using a stratified block randomization algorithm according to number of prior cesarean deliveries and BMI to either salpingectomy or bilateral tubal ligation. The data collection will include preoperative CBC, time of procedure, postoperative CBC at 24 hours, standard patient demographics, procedural complications, estimated blood loss, return to the OR, length of stay, pain scores, and postoperative complications, including readmission within 6 weeks.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women
- •21 years of age or older
- •Desire permanent sterilization
- •Scheduled for a Cesarean delivery
排除标准
- •Body Mass Index > 50
- •Emergent, 'alpha' Cesarean delivery
- •Single ovary/fallopian tube complex
研究组 & 干预措施
Salpingectomy
Bilateral salpingectomy following cesarean delivery
干预措施: Bilateral Salpingectomy (Procedure)
Tubal Ligation
Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.
干预措施: Bilateral Tubal Ligation (Procedure)
结局指标
主要结局
Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)
时间窗: At least 24 but not greater than 48 hours after surgery
Identify the mean difference in pre and postoperative hemoglobin for patients undergoing salpingectomy for sterilization vs. patients undergoing standard bilateral tubal ligation via mid-segment resection of the fallopian tube at the time of cesarean delivery.
次要结局
- Operative Time(Day of surgery)
- Estimated Blood Loss(Day of surgery)
研究者
Vanessa Torbenson
Consultant Obstetrics and Gynecology
Mayo Clinic