Capsule Endoscopy vs Standard of Care for Obscure Intestinal Bleeding
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|ClinicalTrials.gov Identifier: NCT00694954|
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia||Device: Diagnostic Test - Given Imaging Pillcam Other: Diagnostics||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Capsule Endoscopy vs Standard Care in Patients With Iron Deficiency Anemia With Suspected Obscure / Occult Gastrointestinal Bleeding|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||July 2016|
Wireless capsule endoscopy
Device: Diagnostic Test - Given Imaging Pillcam
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)
Active Comparator: 2
Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy.
- diagnostic yield [ Time Frame: 48 weeks ]
- number of blood transfusions [ Time Frame: 48 weeks ]
- number of hospitalizations for GI bleeding/anemia [ Time Frame: 48 weeks ]
- number of GI-related procedures and investigations [ Time Frame: 48 ]
- procedure-related complications [ Time Frame: 48 ]
- 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
- health care costs [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694954
|University of Calgary|
|Calgary, Alberta, Canada, T2N 4N1|
|Principal Investigator:||Catherine J. Dube, MD PhD||University of Calgary|