NCT00130715已完成不适用
A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
Genzyme, a Sanofi Company24 个研究点 分布在 5 个国家开始时间: 1998年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 24
- 主要终点
- Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm occurring within 30 days postoperatively, and the incidence of abdominopelvic abscess within 6 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were undergoing colon and/or rectal resections and/or adhesiolysis for treatment of bowel obstruction
排除标准
- •Patients with any medical condition or disease where 5-year survival was not expected
- •Patients undergoing laparoscopy
- •Patients undergoing surgery for treatment of acute abdominal trauma
- •Patients with an abscess (abdominal or pelvic) present during the initial surgery
- •Patients with a history of pulmonary embolus or deep vein thrombosis (DVT) within 1 year of surgery
结局指标
主要结局
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
次要结局
未报告次要终点
研究者
研究点 (24)
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