NCT06036303招募中不适用
Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery
ClinAmygate1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- duration of port site closure
研究概览
简要总结
The study will investigate the efficacy and safety of a new fascial closure device "Nasr Fascial Closure Device" compared to the Karl Storz Berci Fascial Closure Device 26173AM.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18
- •eligible for Laparoscopic cholecystectomy
排除标准
- •refused to participate
结局指标
主要结局
duration of port site closure
时间窗: 1 day
Duration in seconds
Rate of failure of port site
时间窗: 1 day
Rate of failure to close the port site
次要结局
- Incidence of port site hernia(6 weeks)
- Incidence of port site infection(1 month)
研究者
研究点 (1)
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