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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Iron Deficiency Anemia

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

diagnostic yield

Outcome Time Frame:

48 weeks

Safety Issue:

No

Principal Investigator

Catherine J. Dube, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Calgary

Authority:

Canada: Health Canada

Study ID:

E20270

NCT ID:

NCT00694954

Start Date:

February 2007

Completion Date:

December 2013

Related Keywords:

  • Iron Deficiency Anemia
  • Iron deficiency anemia
  • Wireless capsule endoscopy
  • Obscure-occult gastrointestinal bleeding
  • Anemia
  • Gastrointestinal Hemorrhage
  • Hemorrhage
  • Deficiency Diseases
  • Anemia, Iron-Deficiency

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