NCT00989560已完成3 期
Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Endoscopic recurrence of disease
研究概览
简要总结
This randomised, controlled study aims to evaluate the impact of endoscopic assessment, and adjustment of therapy, after surgery in patients with Crohn's disease. The primary endpoint is the severity of endoscopic recurrence. In addition, tissue will be collected for microbiological and immunological analysis.
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
- None
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
- •clinical diagnosis of Crohn's and proven history of disease
- •patient undergone surgical resection with creation of a primary anastomosis
排除标准
- •endoscopically inaccessible anastomosis by standard colonoscopy
- •presence of an end stoma
- •pregnancy
- •suspected perforation of the gastrointestinal tract
- •presence of certain unsuitable comorbidities
结局指标
主要结局
Endoscopic recurrence of disease
时间窗: 18 months
次要结局
未报告次要终点
研究者
Michael Kamm
Professorial Fellow, Department of Medicine
University of Melbourne
研究点 (2)
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