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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
diagnostic yield
48 weeks
No
Catherine J. Dube, MD PhD
Principal Investigator
University of Calgary
Canada: Health Canada
E20270
NCT00694954
February 2007
December 2013
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