NCT00771407已完成4 期
A Prospective, Multicenter, Randomized, Controlled, Third-party Blinded Study of Strattice Fascial Inlay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- LifeCell
- 入组人数
- 120
- 试验地点
- 24
- 主要终点
- Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.
研究概览
简要总结
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, 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
- •need for permanent ileostomy or colostomy
排除标准
- •history of hernia at new ostomy site
- •has previously implanted surgical mesh at site of planned ostomy
- •requires a temporary ostomy
- •has need for multiple ostomies
- •is receiving chronic immunosuppression therapy, has MELD score of > 17, has severe COPD, systemic infection, or known collagen disorder
- •is bedridden or otherwise non-ambulatory
结局指标
主要结局
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.
时间窗: 24 months
次要结局
- Stoma Complications(more than 1 month postoperatively)
- Stoma Quality of Life(Serially over 24 months)
研究者
研究点 (24)
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