Salpingectomy During Cesarean Section, for Risk Reduction of Ovarian Cancer, Compared With Tubal Ligation- Morbidity and Long Term Complications
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- intra- operative complications
研究概览
简要总结
Based on the accumulated literature, salpingectomy may significantly reduce the risk for ovarian cancer. If investigators can prove that there is no increase in surgical complications and morbidity during salpingectomy in CS, compared to tubal ligation, investigators can recommend for women who are interested in sterilization- salpingectomy during cesarean section .
详细描述
Until recently, ovarian resection was considered the only option to prevent ovarian cancer. Recently new evidence showing that the fallopian tube itself may be the source of certain types of ovarian cancer. So salpingectomy, may offer some protection. However, the extent of this protection has not been determined. Therefore, and based on the foregoing, the investigators think there is an advantage in removal of fallopian tubes rather than tubal ligation Cesarean sections. Given the lack of evidence in the literature about the complications of this procedure, currently the investigators organize a study examines the rate of complications of salpingectomy compared to tubal ligation during cesarean section.
Therefore, the main objective of the study is to assess the incidence of intra-operative complications during cesarean section.
The effect of the procedure will be examined on the following indicators:
- The duration of the operation,
- The rates of bleeding during the operation as estimated by the surgeon,
- hemoglobin before and after the surgery,
- Rates of giving blood or after surgery
- The technical difficulty in performing tubal resection according to surgeon assessment
- The need for further surgical intervention
A secondary objective of the study is evaluating the long-term 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
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women planned for cesarean section , according to medical or obstetric indication , and seek sterilization
- •Women aged 30 and older
- •Women who are capable to understand , read and sign an informed consent form
排除标准
- •women aged less then 30 years
- •women who disagree to participate in the research
结局指标
主要结局
intra- operative complications
时间窗: 5 days
operation duration,hemorrhage, technical difficulty in performing salpingectomy during CS
次要结局
- long term complication(3 months)
研究者
enab.kadour
MD
Bnai Zion Medical Center