PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Incisional hernia
研究概览
简要总结
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
详细描述
Incisional hernia after loop-ileostomy closure may be an underestimated problem. Research on both biological and synthetic mesh in this context is scarce and no randomized controlled trials comparing meshes exist.
The aim of this study is to compare Parietene Macro and Permacol in prevention of incisional site hernia after temporary loop-ileostomy reversal after anterior resection and TME for rectal cancer.
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 (Participant, Outcomes Assessor)
盲法说明
Subject is blinded of the mesh used. Outcome at 10 month follow-up is assessed by surgeon who was not involved in the operation.
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
- •Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
- •18 years or older
- •Patient has a life expectancy of at least 12 months.
- •Patient signs the Informed consent and agrees to attend all study visits
排除标准
- •Patient with a comorbid illness or condition that would precluded the use of surgery (ASA 4-5).
- •Patients with concurrent or previous malignant tumors within 5 years before study enrollment
- •Patients with T4b tumors which imposed a multi-organ resection
- •Patient undergone emergency procedures
- •Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
- •Metastatic disease with life expectancy of less than 12 months
- •Pregnancy or suspected pregnancy
结局指标
主要结局
Incisional hernia
时间窗: 10 months
Incidence of incisional hernia
Surgical site infection
时间窗: 30 days
The incidence of surgical site infections at 30 days follow up
次要结局
- Operative time(30 days)
- Incidence of hernia(5 years)
- Complications classified by Clavien-Dindo classification(30 days)
- Re-operation rate(5 years)
- Cost analysis(5 years)
- Length of stay(30 days)
- Quality of life measured by RAND-36 survey(5 years)