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OpenTrials
Completed

NCT Number: NCT00694954

Capsule Endoscopy vs Standard of Care for Obscure Intestinal 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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Pregnancy
  • Inability to provide informed consent

Treatment and study plan

Diagnostic Test - Given Imaging Pillcam

Device

Procedure performed once only after randomization. If procedure is incomplete due to a number of variables, procedure may possibly need to be repeated.

Diagnostic possibilities: normal exam, active bleeding, potential source of bleeding (angiodysplasia, ulcer, tumor)

Other names: Capsule endoscopy, Given Imaging Pillcam, Pill camera

Diagnostics

Other

Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.

Primary outcomes

  1. diagnostic yield

    Time frame: 48 weeks

Secondary outcomes

  1. number of blood transfusions

    Time frame: 48 weeks

  2. number of hospitalizations for GI bleeding/anemia

    Time frame: 48 weeks

  3. number of GI-related procedures and investigations

    Time frame: 48

  4. procedure-related complications

    Time frame: 48

  5. quality of life

    Time frame: 48

    measured by 1) SF36 - 8 domains + PCS/MCS, 2) GI Quality of Life Index (GIQLI), 3) EQ-5D - index + visual analogue scale

  6. health care costs

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Alberta Heritage Foundation for Medical Research
  • Calgary Health Region

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2015
Study completion
2016
First posted
Jun 11, 2008
Registry last updated
Dec 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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