Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 4
- 主要终点
- Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.
研究概览
简要总结
The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial.
Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •elective repair for a primary unilateral inguinal hernia OR
- •elective repair for a recurrent unilateral inguinal hernia after non-mesh repair
排除标准
- 未提供
结局指标
主要结局
Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.
时间窗: 12 months post-surgery
A CT scan is performed.
次要结局
- Pain assessment.(after 1 year)
- Recurrence of hernia.(after 1 year)
- Wound morbidity.(after 4 weeks)
- Discomfort assessment.(after 1 year)
- Use of oral analgetics.(after 1 year)