A Randomized Controlled Trial of Capsule Endoscopy vs Standard Care in Patients With Iron Deficiency Anemia With Suspected Obscure / Occult Gastrointestinal Bleeding
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.
1. 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.
2. Eligible patients should have a negative gastroscopy and negative colonoscopy within
1 year prior to entry into study.
3. Negative celiac screen and /or negative small bowel biopsies
1. Overt gastrointestinal bleeding
2. Premenopausal women with menorrhagia
3. Known or suspected small bowel obstruction
4. Serious medical co-morbidities precluding surgery given the risk of capsule impaction
6. Inability to provide informed consent
Type of Study:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Time Frame:
Catherine J. Dube, MD PhD
University of Calgary
Canada: Health Canada
- Iron Deficiency Anemia
- Iron deficiency anemia
- Wireless capsule endoscopy
- Obscure-occult gastrointestinal bleeding
- Gastrointestinal Hemorrhage
- Deficiency Diseases
- Anemia, Iron-Deficiency