Diagnostic Yield of Video Capsule Endoscopy for Iron Deficiency Anaemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
This project aim to investigate whether wireless capsule endoscopy(WCE) has a similar diagnostic yield as conventional endoscopy in detecting the cause of iron deficiency anemia (IDA)
详细描述
IDA is common and 90-95% of cases are caused by bleeding from ulcers, tumours or vascular malformations in the oesophagus, stomach, duodenum, small intestine or the large bowel.Bleeding from more than one localisation is common.
International guidelines recommend bidirectional endoscopy(gastro- and colonoscopy) to detect and treat the source of bleeding.
Our hypothesis is that WCE is non-inferior to the combination of gastroscopy and colonoscopy in locating GI-bleeding and that complete examinations will be achieved in ≥90% of the examinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Referred to flexible endoscopy for a verified Iron Deficiency Anaemia
排除标准
- •Unwillingness to participate
- •Not able to provide informed consent
- •Not understanding the instructions
- •Severe cardio-vascular disease New York Heart Association III-IV
- •Symptoms of bowel obstruction/previous bowel obstruction
- •Bowel surgery except for end to end anastomosis in the colon
- •Pregnancy
结局指标
主要结局
Diagnostic yield
时间窗: 90 minutes
Mucosal lesions detected
次要结局
- Small bowel lesions(90 minutes)
- Adequate examinations(90 minutes)
- Complete examination(90 minutes)
- Bowel preparation(90 minute)