NCT00925067已完成不适用
Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
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
- 59
- 试验地点
- 1
- 主要终点
- Male fertility aspects
研究概览
简要总结
A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Primary, unilateral or bilateral, inguinal hernia patients
- •Informed consent
排除标准
- •Sterilized patients
研究组 & 干预措施
lightweight TiMesh
Experimental
干预措施: lightweight TiMesh (Device)
lightweight TiMesh
Experimental
干预措施: laparoscopic (TEP) inguinal hernia repair (Procedure)
lightweight VyproII
Experimental
干预措施: laparoscopic (TEP) inguinal hernia repair (Procedure)
lightweight VyproII
Experimental
干预措施: lightweight VyproII (Device)
Heavyweight Marlex
Experimental
干预措施: Heavyweight Marlex (Device)
Heavyweight Marlex
Experimental
干预措施: laparoscopic (TEP) inguinal hernia repair (Procedure)
结局指标
主要结局
Male fertility aspects
时间窗: 12 months
次要结局
- Quality of life, pain development, recurrence(1, 3, 6 and 12 months)
研究者
研究点 (1)
Loading locations...
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