Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 381
- 试验地点
- 1
- 主要终点
- radiological incisional hernia rate
研究概览
简要总结
This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer
详细描述
This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer.
Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure.
Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.
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)
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
- •Age > 18
- •Operated on for diverting ileostoma closure after sphincter saving rectal cancer surgery, irrespective of the time delay between ileostoma closure and rectal cancer surgery
- •Signed consent
- •Affiliation to the French social security system
排除标准
- •Emergency surgery
- •History of laparotomy before ileostoma closure.
- •Surgery associated to the ileostoma closure, excluding appendectomy or liver biopsy
- •Lactating or pregnant woman
- •Allergy to porcine product or collagen-based product. Allergy to polypropylene.
- •Participation to another protocol focusing on ileostoma closure
研究组 & 干预措施
Synthetic Mesh
Synthetic mesh placed in retromuscular position
干预措施: Synthetic Mesh (Device)
Biologic Mesh
Biologic mesh placed in retromuscular position
干预措施: Biologic Mesh (Device)
No Mesh
No mesh
结局指标
主要结局
radiological incisional hernia rate
时间窗: up to 36 months
Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up. Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient
次要结局
- Postoperative morbidity(30 days)
- Postoperative pain(36 months)
- Postoperative rehospitalization(36 months)
- Postoperative reintervention(36 months)
- Clinical incisional hernia rate(36 months)
- Quality of life (The Short Form (36) Health Survey score)(12 months)