NCT00323141已完成不适用
Prospective Randomized Trial to Study the Effectiveness of an Intraperitoneal Mesh With an Overlap of 3cm Versus a Rives-Stoppa Repair With an Overlap of 6cm With Patients With a Hernia Umbilicalis
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
- 50
- 试验地点
- 2
- 主要终点
- Number of relapses after 1 and 3 years
研究概览
简要总结
To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Symptomatic hernia umbilicalis
- •> 18 years old
排除标准
- 未提供
研究组 & 干预措施
Ventralex
Active Comparator
干预措施: Ventralex versus Leight Weight Vypro II prothesis (Device)
Leight Weight Vypro II prothesis
Active Comparator
干预措施: Ventralex versus Leight Weight Vypro II prothesis (Device)
结局指标
主要结局
Number of relapses after 1 and 3 years
时间窗: after 1 and 3 years
次要结局
- Duration of surgery(Depends from type of surgery.)
- Duration of hospitalisation(Depends from type of surgery.)
- Frequency of complications(After 1 and 3 years.)
- Pain assessment(After 1 and 3 years.)
研究者
研究点 (2)
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