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| ID | Type | Description | Link |
|---|---|---|---|
| Internal tracking #1763 |
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| Name | Class |
|---|---|
| Alberta Heritage Foundation for Medical Research | OTHER |
| Calgary Health Region | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Wireless capsule endoscopy |
|
| 2 | Active Comparator | Standard Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| diagnostic yield | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| number of blood transfusions | 48 weeks | |
| number of hospitalizations for GI bleeding/anemia | 48 weeks | |
| number of GI-related procedures and investigations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine J. Dube, MD PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D053704 | Capsule Endoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
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| Diagnostics | Other | Any other diagnostic tests (if not already performed) that the referring or attending physician deems necessary aside from Wireless Capsule Endoscopy. |
|
| 48 |
| procedure-related complications | 48 |
| quality of life | measured by 1) SF36 - 8 domains + PCS/MCS, 2) GI Quality of Life Index (GIQLI), 3) EQ-5D - index + visual analogue scale | 48 |
| health care costs | 2 years |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |