Iron Deficiency Anemia Clinical Trial
Official title:
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.
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