NCT00184483已完成不适用
Randomized Multi Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- pain postoperative
研究概览
简要总结
Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary unilateral groin hernia in adult
排除标准
- •recurrence warfarin treatment bilateral groin hernia
研究组 & 干预措施
Lichtenstein's operation
Experimental
Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia
干预措施: Lichtenstein's operation (Procedure)
Prolene Hernia System
Active Comparator
Patients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia
干预措施: Prolene Hernia System (Procedure)
结局指标
主要结局
pain postoperative
时间窗: 3 years
次要结局
- Recurrences after groin hernia repair(3 years)
研究者
研究点 (1)
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