NCT04679116Unknown不适用
Laparoscopic vs Open Bilateral Inguinal Hernia Repair
General Hospital of Larissa2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Post operative Pain
研究概览
简要总结
The European Hernia Society Guidelines of 2018 suggest that laparoscopic surgery should be preferred over open surgery for bilateral inguinal hernia repair even though scientific evidence are scarce. We will conduct a prospective, non randomise control trial, to investigate the superiority of one technique over the other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- Male
- 接受健康志愿者
- 否
入选标准
- •bilateral inguinal hernia
排除标准
- •American Society of Anaesthesiology score >3
- •complicated inguinal hernias
结局指标
主要结局
Post operative Pain
时间窗: 24 hours post surgery
Evaluation of the post operative pain 24 hours after surgery. For the assessment of the pain will be used the Visual Analog Scale (VAS) score. (VAS Score Scale from 0-10, 0 no pain, 10 max pain)
次要结局
- urinary retention(8 hours)
- foreign body sensation to the inguinal area(1 year)
- days of hospitalization(30 days)
- chronic pain(1 year)
- complications(30 days)
- recurrence(1 year)
研究者
Georgios Koukoulis
General Surgery Consultant
General Hospital of Larissa
研究点 (2)
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