NCT02168426已完成3 期
Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- ileus rate
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days 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 (Participant)
入排标准
- 年龄范围
- 25 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of GI cancer
排除标准
- •Withdrew consent
- •Distant metastasis
- •Liver dysfunction (serum total bilirubin >2.0 mg/dL)
- •Renal failure (serum creatinine >1.5 mg/dL)
- •A past history of small bowel obstruction.
结局指标
主要结局
ileus rate
时间窗: within 60 days
Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
次要结局
- adverse effect rate(within 60 days)
研究者
Won-Suk Lee
Won-Suk Lee
Gachon University Gil Medical Center
研究点 (1)
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