Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin levels on postoperative day one
研究概览
简要总结
One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.
A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •request for permanent sterilization at the time of cesarean delivery
- •24 weeks' gestation or beyond
- •21 years old or older
- •Medicaid sterilization consent per Virginia Department of Medical Assistance Services regulations (if Medicaid recipient).
排除标准
- •vaginal delivery
- •history of prior adnexal surgery (such as prior bilateral tubal ligation or unilateral salpingectomy oophorectomy)
- •placenta accreta spectrum
- •placenta previa
- •history of bleeding diathesis.
研究组 & 干预措施
Complete salpingectomy using traditional suture ligation
干预措施: Traditional suture ligation (Other)
Complete salpingectomy using a hand-held bipolar energy instrument
干预措施: Hand-held bipolar energy instrument (Other)
结局指标
主要结局
Change in Hemoglobin levels on postoperative day one
时间窗: preoperatively and one day after surgery
Change in hemoglobin levels reported in gram per deciliter on postoperative day one, calculated as the difference between immediate preoperative and postoperative day 1 hemoglobin levels
次要结局
- Completion rate of sterilization(preoperatively and one day after surgery)
- Total procedure estimated blood loss(intraoperatively)
- Total operative time(intraoperatively)
- ICU admission(from day of surgery up to 7 days postpartum)
- Hospital readmission postoperatively(Day of initial dischage through 6 weeks postpartum)
- Cost(intraoperatively)
- Adjacent organ damage(intraoperatively)
- Need for blood transfusion(from day of surgery up to 30 days pospartum)
- Length of hospital stay(from day of surgery up to 6 weeks postpartum)
- Reoperation rates(postoperative day 0 through 6 weeks postpartum)
- Pain score(from day of surgery up to 7 days postparum)
- Surgical site infection(postoperative day 0 through 6 weeks postpartum)