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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
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.
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.
Time frame: 1 month
The time of the bleeding lesions detected from admission
Time frame: 1 month
The number of procedures patients underwent for detection of the bleeding lesions
Time frame: 1 month
The number of colonoscopy needed
Time frame: 1 month
Rate of therapeutic intervention required of all patients
Therapeutic interventions include therapeutic endoscopy, radiologic intervention or surgery.
Time frame: 1 month
The length of hospital stay
Time frame: 1 month
The cumulative direct cost of hospitalization
Time frame: 1 month
Time to therapeutic intervention from presentation
Time frame: 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.
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Time frame: 1 month
The all-cause mortality within 30 days of discharge
Time frame: 1 month
Transfusion rate
Time frame: 1 month