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few patients met all the inclusion criteria
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MCE first algorithm is not inferior to standard of care algorithm in terms of further bleeding in hemodynamically stable patients with acute overt and non-hematochezia GI bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCE first group | Experimental | Patients randomized to the "MCE first group" will have a MCE deployed as the first detection method. |
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| standard of care group | No Intervention | For patients randomized to the Standard Care Group, gastroenterologists choose which procedures to perform and when to perform them based on their interpretation of the patient's presentation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCE first | Diagnostic Test | Patients randomized to the "MCE first group" will have a MCE deployed as soon as possible once confirmed to fast for at least 8 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of bleeding lesions detection. | Detection rate of bleeding lesions is defined as proportion of patients in whom a potential bleeding lesion is identified. Visualization of gross blood (fresh/coffee grounds) without any lesion will not be considered as a positive diagnosis. The panel will provide a diagnosis based upon the lesion presenting the highest potential for bleeding if there are many lesions detected. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| The time of the bleeding lesions detected from admission | 1 month | |
| The number of procedures patients underwent for detection of the bleeding lesions | 1 month | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008551 | Melena |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
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| The number of colonoscopy needed |
| 1 month |
| Rate of therapeutic intervention required of all patients | Therapeutic interventions include therapeutic endoscopy, radiologic intervention or surgery. | 1 month |
| The length of hospital stay | 1 month |
| The cumulative direct cost of hospitalization | 1 month |
| Time to therapeutic intervention from presentation | 1 month |
| The rate of recurrent bleeding within 30 days of discharge | Further bleeding is defined as overt (hematemesis, melena or hematochezia) or occult (anemia or fecal occult blood positive) bleeding requiring subsequent hospitalization or transfusion, and/or signs of hypovolemic shock (systolic blood pressure of <100 mmHg and pulse rate >100 per min) or a drop-in hemoglobin level of >2g/dL per 24hours. | 1 month |
| The all-cause mortality within 30 days of discharge | 1 month |
| Transfusion rate | 1 month |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |