Comparison Between 2 Techniques for Bilateral Salpingectomy During Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Total salpingectomy time.
研究概览
简要总结
A comparison between 2 techniques for bilateral salpingectomy during cesarean section.
Primary outcomes are total operative time and bilateral completion of the randomized procedure. Secondary outcomes included surgical complications and post operation complications.
详细描述
Ovarian cancer is the most lethal gynecologic malignancy. Major contributors to this high mortality are the lack of effective screening strategies, diagnosis at advanced stage of presentation as well as the high risk of recurrence. In the last years the Gynecologic Associations worldwide have recommended that total salpingectomy be considered for potential ovarian cancer risk reduction in benign gynecologic surgeries after completion of childbearing.
However, the data are limit regarding the Preferred surgical technique during cesarean section.
In this randomized controled trial the investigators will compare between various techniques for bilateral salpingectomy during cesarean section.
Primary outcomes are total operative time and bilateral completion of the randomized procedure. Secondary outcomes included surgical complications and post operation complications.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants undergoing elective Cesarean Section and are interested and have signed informed consent regarding bilateral salpingectomy.
排除标准
- •Inability to give informed consent.
- •Preterm delivery (< 37 weeks' gestation).
- •Fetal demise.
- •Prenatal diagnosis of fetal or placental abnormalities.
- •Previous tubal surgery.
- •The use of anticoagulants.
- •Associated immunosuppressive conditions.
研究组 & 干预措施
Study group
Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.
干预措施: LIGASURE (Device)
Control group
Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.
干预措施: Clamping and suturing (Procedure)
结局指标
主要结局
Total salpingectomy time.
时间窗: Up to 1 week from recruitment
Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.
次要结局
- Bleeding during cesarean section(Up to 4 hours from the beginning of the procedure)
- Need for opioids(Up to 2 weeks from surgery)
- Hemoglobin level(Up to 5 days from surgery)
- Postoperative stay(Up to 2 weeks from surgery)
- Blood transfusion rate(Up to 5 days from surgery)
- Bleeding during salpingectomy(Up to 4 hours from the beginning of the procedure)
- Visual analogue score(Up to 2 weeks from surgery)
- Wound complications(Up to 2 weeks from surgery)
研究者
Yaniv Zipori MD
Principal Investigator
Rambam Health Care Campus