Expired Study
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Saint Louis, Missouri 63110


Purpose:

Acute gastrointestinal bleeding is a common medical problem. When patients with gastrointestinal bleeding present with melena (dark, tarry stool) the blood loss is usually originating in the upper gastrointestinal tract (esophagus, stomach or duodenum) and first step in evaluating the patient is an upper endoscopy; which allows direct visualization of the esophagus, stomach and duodenum. However, the cause of bleeding is located in the small bowel or colon in 20-30% of patients who present with melena. Traditionally colonoscopy has been the next test preformed if upper endoscopy does not identify the cause of melena/ gastrointestinal bleeding, however less than 25% of patients who present with melena have bleeding originating in the colon, and the remainder of patients have bleeding originating in the small intestine, which can only be fully evaluated with video capsule endoscopy (a pill camera which is swallowed and takes pictures while it travels thought the small bowel and colon). Currently patients only undergo video capsule endoscopy if colonoscopy does not identify the cause of bleeding. The investigators are preforming a randomized study which seeks to determine if colonoscopy or video capsule endoscopy is a better way to identify the cause of gastrointestinal bleeding in patients who present with melena and have normal findings on upper endoscopy. To do this the investigators will enroll patients who present with melena prior to their upper endoscopy and if the cause of bleeding is not identified at that time patients will be randomized to video capsule endoscopy (with the capsule being placed into the small bowel during the upper endoscopy) or next day colonoscopy.


Criteria:

Inclusion Criteria: • Inpatients >18 years of age presenting with lower gastrointestinal bleeding and have melenic stool Exclusion Criteria: - Unable to provide written informed consent - A probable bleeding source is identified on upper endoscopy - Pregnancy or lactation - Swallowing Disorder - Unable to tolerate sedation or anesthesia due to medical co-morbidities - Uncorrected coagulopathy (platelet count <50,000, INR> 2, PTT> 2x upper limit of normal) - Known or suspected gastrointestinal obstruction or stricture - Cardiac pacemaker or other implanted electromedical device - Contraindication to bowel preparation


NCT ID:

NCT02609100


Primary Contact:

Principal Investigator
Vladimir M Kushnir, MD
Washington University School of Medicine


Backup Contact:

N/A


Location Contact:

Saint Louis, Missouri 63110
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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