Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding

A Randomized Controlled Trial of Capsule Endoscopy vs Standard Care in Patients With Iron Deficiency Anemia With Suspected Obscure / Occult Gastrointestinal Bleeding

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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

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
5. Pregnancy
6. Inability to provide informed consent