A Randomized Controlled Trial of Capsule Endoscopy vs Standard Care in Patients With Iron Deficiency Anemia With Suspected Obscure / Occult Gastrointestinal Bleeding
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Calgary
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- diagnostic yield
Study Overview
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 yield and clinical outcomes of patients with obscure GI bleeding who receive CE compared to those who receive usual standard care.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
- •Inability to provide informed consent
Arms & Interventions
1
Wireless capsule endoscopy
Intervention: Diagnostic Test - Given Imaging Pillcam (Device)
2
Standard Care
Intervention: Diagnostics (Other)
Outcomes
Primary Outcomes
diagnostic yield
Time Frame: 48 weeks
Secondary Outcomes
- number of hospitalizations for GI bleeding/anemia(48 weeks)
- number of GI-related procedures and investigations(48)
- number of blood transfusions(48 weeks)
- quality of life(48)
- health care costs(2 years)
- procedure-related complications(48)
Investigators
Dr. Robert Hilsden
Associate Professor
University of Calgary