Comparison of Conventional Laparoscopy and Natural Orifice Transluminal Endoscopic Surgery in the Surgical Treatment of Tubal Ectopic Pregnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reoperation rate
研究概览
简要总结
In this study we aim to compare conventional laparoscopy and natural orifice transluminal endoscopic surgery in the surgical treatment of ectopic pregnancy.
All the patients, with an indication of surgery for ectopic pregnancy, will be asked to participate in this clinical trial.
Indication of surgery will be based on clinical findings, ultrasound scans and serum hcg levels. There will be no exclusion criteria.
Duration of surgery, successful completion of the operation, intraoperative data and postoperative data will be collected.
All the patients will be asked to fill out quality of recovery-40 (QoR-40) questionnaire and 36-item short form health survey (SF-36) before surgery.
QoR-40 questionnaire will be repeated 24 hours after surgery and repeated every 24 hours until discharge. SF-36 will be repeated at 1-month follow-up visit. Patients will be also evaluated at postoperative 3-months, and female sexual function index will be asked to be filled-out.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years of age,
- •Diagnosis of tubal ectopic pregnancy
- •Patient's preference to undergo salpingectomy
排除标准
- •Patients with contraindication to endoscopic surgery
- •Refusal to sign informed consent.
结局指标
主要结局
Reoperation rate
时间窗: During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Complication rate
时间窗: During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Operating time
时间窗: Intraoperative
Successful completion of surgery as intended
时间窗: Intraoperative, from the beginning to the end of surgical intervention
The completion of the surgery with the route planned without having to change the surgical route
次要结局
- Quality of life change(Preoperative, Postoperative 1-month)
- Postoperative pain scores(Postoperative 2 hours, 6 hours, 12 hours, 24 hours, and every 24 hours until discharge (if the patient stays longer than 1 day at the hospital), , expected to be up to 3 days following surgery)
- Sexual function(Postoperative 3 months)
- The need for additional analgesic use(Postoperative period until discharge, expected to be up to 3 days following surgery)
- Quality of Recovery-40 questionnaire(Preoperatively and Postoperative every 24 hours until discharge, expected to be up to 3 days following surgery)