A Randomized Controlled Trial of Capsule Endoscopy vs Standard Care in Patients With Iron Deficiency Anemia With Suspected Obscure / Occult Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- diagnostic yield
研究概览
简要总结
The role of capsule endoscopy (CE) in patients with obscure / occult gastrointestinal (GI) bleeding remains unclear. This pragmatic randomized controlled trial is designed to determine the diagnostic yield and clinical outcomes of patients with obscure GI bleeding who receive CE compared to those who receive usual standard care.
详细描述
Patients with iron deficiency anemia from suspected occult GI bleeding will be randomized to receive CE or usual standard care following a negative gastroscopy and colonoscopy. Our primary outcome measure (diagnostic yield) and secondary outcome measures (noted below) will be determined after one year of followup. Patients with have a minimum of one year of clinical followup. Direct health care costs in each arm of the study will be determined after a minimum of two years of followup.
An economic evaluation based on the results of the clinical trial is also planned.
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
- •Adult patients age over 18years with iron deficiency anemia (IDA). IDA is defined as hemoglobin <137g/L in men or <120g/L in women with serum ferritin level <22ug/L in men and <10ug/L in women.
- •Eligible patients should have a negative gastroscopy and negative colonoscopy within 1 year prior to entry into study.
- •Negative celiac screen and /or negative small bowel biopsies
排除标准
- •Overt gastrointestinal bleeding
- •Premenopausal women with menorrhagia
- •Known or suspected small bowel obstruction
- •Serious medical co-morbidities precluding surgery given the risk of capsule impaction
- •Inability to provide informed consent
研究组 & 干预措施
1
Wireless capsule endoscopy
干预措施: Diagnostic Test - Given Imaging Pillcam (Device)
2
Standard Care
干预措施: Diagnostics (Other)
结局指标
主要结局
diagnostic yield
时间窗: 48 weeks
次要结局
- quality of life(48)
- number of blood transfusions(48 weeks)
- health care costs(2 years)
- number of hospitalizations for GI bleeding/anemia(48 weeks)
- number of GI-related procedures and investigations(48)
- procedure-related complications(48)
研究者
Dr. Robert Hilsden
Associate Professor
University of Calgary