Prospective, Multicenter, Randomized, Parallel Group Clinical Study Evaluating the Efficacy of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 7
- 主要终点
- rate of parastomal hernia
研究概览
简要总结
In France around 5,000 colostomies are performed after elective or emergency surgery. These colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases.
To reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception.
Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the prevention of parastomal hernia.
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
- 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
- •Patient requiring a colorectal surgery with a terminal colostomy
- •Elective or emergency surgery
排除标准
- •Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI.
- •Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
- •Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs
- •Is pregnant, or lactating.
- •Allergic to any porcine or collagen products.
- •survival < 6 months
研究组 & 干预措施
Strattice
a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception
干预措施: strattice (Device)
No strattice
the colostomy is not reinforced with a mesh
干预措施: No strattice (Procedure)
结局指标
主要结局
rate of parastomal hernia
时间窗: postoperative month 6
the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan
次要结局
- the quality of life(2 years after the surgery)
- evaluation of the pain(2 years after the surgery)
- the postoperative morbidity(postoperative month 1)
- the parastomal hernia rate(postoperative year 1)