An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- sf36
研究概览
简要总结
The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted
详细描述
The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted. Patients randomized 1:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Age 18 or older
- •Obscure overt GI bleeding
- •No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding
排除标准
- •Known or suspected swallowing disorders
- •Known or suspected small bowel obstruction
- •Multiple comorbidities precluding surgery
- •Patients with implantable electromagnetic devices
- •Pregnant women
研究组 & 干预措施
1
Wireless capsule endoscopy
干预措施: Wireless capsule endoscopy (Device)
2
Standard care
干预措施: standard care (Other)
结局指标
主要结局
sf36
时间窗: 48 weeks
diagnostic yield
时间窗: 48 weeks
giqli
时间窗: 48 weeks
eq50
时间窗: 48 weeks
次要结局
- transfusions(48 weeks)
研究者
Dr. Robert Hilsden
Associate Professor, Department of Medicine & Research Director, Colon Cancer Screening Centre
University of Calgary