The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement.
研究概览
简要总结
The use of mesh in the repair of umbilical hernias is a gold standard. The best location of the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal cavity (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so not in contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists of polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and the surgery.
This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene for preperitoneal use), will be used in this multicentric trial, to evaluate the best procedure in terms of efficacy, safety and postoperative complications.
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
- Single (Participant)
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
- •written informed consent from the patient or his/her legal representative
- •primary umbilical hernia requiring elective surgical repair
- •diameter between 0 and 3 cm
排除标准
- •no written informed consent
- •incisional hernia at the level of the umbilicus
- •recurrent umbilical hernia, as they have to be considered an incisional hernia
- •emergency surgery (incarcerated hernia)
- •pregnancy
- •non-compliance
结局指标
主要结局
Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement.
时间窗: Total duration of the operation with an expected average of approximately 45 minutes.
Time registration of the operating time will be extracted from the hospital electronic patient files.
次要结局
- Surgical wound morbidity complication rate.(Up to 1 year.)
- Recurrence Rate(up to 2 years)
- Pain evaluation(within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years)
- Discomfort evaluation.(Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years.)