NCT02948205Unknown不适用
Analysis of Trans-umbilical Laparoendoscopic Single-site Surgery by 3D Laparoscopy in the Treatment of Infertility
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 主要终点
- pain score
研究概览
简要总结
This study intends to carry out a prospective, randomized controlled trial to compare the trans-umbilical laparoendoscopic single-site surgery by 3D laparoscopy with normal laparoendoscopic surgery in the treatment of infertility patient, so as to further clarify the safety and curative effect of TU-LESS by 3D laparoscopy and provide evidence-based basis for its application in infertility population.
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
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients are younger than 36 and older than
- •Clearly diagnosed with female Infertility.
- •Infertility within 1 to 10 years.
- •informed consent form signed
排除标准
- •Over the age of
- •Indefinite diagnosis.
- •With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
- •abdominal surgery history
- •Unwilling to comply with the research plan.
研究组 & 干预措施
3D group
Experimental
infertility patient get TU-LESS by 3D Laparoscopy
干预措施: 3D group (Procedure)
normal group
Other
infertility patient get normal laparoscopic surgery
干预措施: normal group (Procedure)
结局指标
主要结局
pain score
时间窗: in 24 hours after surgery
Visual Analogue Score for the pain feeling of the patient
pregnancy rate
时间窗: 6 months after surgery
次要结局
- Operation time(intraoperative)
研究者
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