"Prospective Randomized Clinical Trial of Ileostomy Closure Site Hernia and it´s Prophylaxis by Placing an Absorbable Mesh "
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Eventration
研究概览
简要总结
Design Prospective , randomized, parallel phase IV.
Objectives Main objective
- Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of incisional hernia of the abdominal wall at the site of a loop ileostomy when it is "closed " to rebuild the intestinal transit. The effectiveness evaluation is done by tracking with scheduled patient visits for 12 months, assessing the physical examination the presence or absence of an incisional hernia and an abdominal tomography at the end of the 12 months .
Secondary objectives Comparison of complications(morbidity and mortality) to assess safety and tolerability of the placement of the mesh described .
详细描述
Experimental: Reinforcement with Absorbable Mesh Closure of the ileostomy closure incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a "sandwich" method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1.
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, Care Provider)
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
- •Patients undergoing a loop ileostomy closure
排除标准
- •Patients under 18
- •Pregnancy and Lactation
- •Patients allergic to polyglycolic / trimethylene carbonate
- •Carrier of prosthetic mesh in the ostomy
- •Patients presenting midline hernia.
- •Patients affected by inflammatory bowel disease
结局指标
主要结局
Eventration
时间窗: 1 year
Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery.
次要结局
- Iatrogenic problems(30 days after surgery)
- Cardiac complications(30 days after surgery)
- Gastrointestinal complications(30 days after surgery)
- Local complications(30 days after surgery)
- Occlusive problems(30 days after surgery)
- Bleeding problems(30 days after surgery)
- Nephro-urinary complications(30 days after surgery)
- Impaired healing(30 days after surgery)
- Neurological complications(30 days after surgery)
- Respiratory complications(30 days after surgery)
- Vascular Complications(30 days after surgery)
- Local infection(30 days after surgery)
- Hospital stay(Days)