Pelvic Congestion Syndrome Following Salpingectomy Compared to Tubal Ligation at Time of Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- symptoms of pelvic congestion syndrome
研究概览
简要总结
Permanent tubal sterilization during Caesarean section is a reliable method of contraception. It is done either by bilateral tubal ligation or bilateral salpingectomy according to surgeon's preference.
Studies revealing bilateral salpingectomy has an added benefit of primary prevention of ovarian cancer has encouraged surgeons to perform bilateral salpingectomy rather than tubal ligation as a risk reducing surgery owing to the acceptance of fallopian tubes as the origin of high grade serous ovarian cancer.
Another aspect to take into consideration is the post tubal ligation syndrome as it severely affects the quality of life. Diagnosis is based on clinical picture, imaging, and exclusion of other causes of chronic pelvic pain. Women experience dysmenorrhea, dyspareunia, menstrual irregularities, and pelvic pain. The gold standard is venography; however, the first choice for initial evaluation is duplex ultrasound.
In this study, we assess impact of bilateral salpingectomy versus tubal ligation in terms of pelvic congestion by participant's symptoms and ultrasound findings
详细描述
Women planned for caesarean delivery and tubal sterilization will be screened for eligibility on presenting to the labor unit.
Informed written consent will be taken from all the participants before enrollment in the study.
Randomization will be done at a 1:1 ratio to bilateral salpingectomy or bilateral tubal ligation by a computer-generated scheme. Sequentially numbered sealed opaque envelopes will be prepared, each containing patient allocated procedure. It will be revealed to the case surgeon.
- Surgical Intervention: Caesarean section and tubal sterilization will be performed by resident on duty.
Identification of the fimbriated end of the Fallopian tube. It will be grasped by a Babcock or Allis forceps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females undergoing caesarean section and requesting tubal sterilization as a permanent method of contraception.
- •30 years or older
排除标准
- •Previous history of tubal surgery (changes in blood flow)
- •Previous history of oophorectomy (changes in blood flow)
- •Congenital anomalies or malformations in fallopian tubes or ovaries. (affection of normal anatomy of pelvic blood vessels)
- •Women diagnosed with pelvic congestion. (Known cause for pelvic congestion other than tubal sterilization)
- •High likelihood of lost to follow up.
- •Inability to provide good data.
结局指标
主要结局
symptoms of pelvic congestion syndrome
时间窗: Ten weeks postoperative
A questionnaire to detect changes in menstrual pattern or new onset of pelvic pain.
次要结局
- intraoperative complications(intraoperative)
- signs of pelvic congestion syndrome(Ten weeks postoperative)