Status:
COMPLETED
Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Alberta Heritage Foundation for Medical Research
Calgary Health Region
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 mea...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Pregnancy
- Inability to provide informed consent
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00694954
Start Date
February 1 2007
End Date
July 1 2016
Last Update
December 5 2017
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4N1