Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Wound infection,mesh infection, parastomal hernia.
研究概览
简要总结
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.
详细描述
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes.
A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection.
Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis.
Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical need of an enterostoma
排除标准
- •Patients denies inclusion in the trial.
结局指标
主要结局
Wound infection,mesh infection, parastomal hernia.
时间窗: Within five years
次要结局
- Fistula formation, stenosis,pain.(Within five years)