NCT01187680终止4 期
Polyethylene Glycol Adhesion Barrier Reduces Adhesions After Gynecologic Laparoscopy; a Prospective Randomized Controlled Pilot Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- successful adhesion prevention
研究概览
简要总结
The purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 years
- •Undergoing gynecologic laparoscopy
排除标准
- •Suspected malignancy
- •Incomplete adhesiolysis during initial laparoscopy
- •Pregnancy
- •Lactating
- •Stage IV endometriosis
研究组 & 干预措施
Spraygel
Experimental
干预措施: Spraygel (Device)
Control
Active Comparator
干预措施: Control (Device)
结局指标
主要结局
successful adhesion prevention
Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.
次要结局
- LABS adhesion score
- Adhesion sites
研究者
研究点 (1)
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