Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal Bleeding

Completed · Not applicable

Conditions studied: Melena, Gastrointestinal Hemorrhage

In brief

The objectives of this study are to test whether there are statistically significant differences between the standard of care workup workup of non-hematemesis gastrointestinal bleeding by endoscopy \[upper, lower and other tests\], compared with deployment of a video capsule as the first test followed by the most appropriate endoscopic procedure based on video capsule findings, if needed. The investigators propose to examine differences in time to diagnosis, reduction in numbers of procedures, and length of stay between a standard of care workup protocol and our proposed protocol of early capsule endoscopy deployment.

Key facts

Study ID

NCT02442830

Run by

University of Massachusetts, Worcester

People needed

87

Starts

2015-04-19

Expected to finish

2017-07-02

Last updated by the study team

2018-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 18 years old
• New onset of melena or hematochezia
• Able to sign consent
• Hemodynamically stable (i.e. blood pressure >100/60 or pulse <110 at the time of consent)
• ED must plan to admit patient to the hospital or Clinical Decision Unit.

You may not qualify if…

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners
• Prior history of gastroparesis
• Prior history of gastric, or small bowel surgery
• Prior history of Crohn's disease
• Concern for infectious colitis
• Non-English speaking
• Evidence of dysphagia at the time of presentation
• Presence of bright red blood per rectum concerning for hemorrhoids
• Allergy to metoclopramide or erythromycin
• Code status of Do Not Resuscitate/Do Not Intubate (DNR/DNI) or Comfort Measures Only (CMO)
• Prior history of abdominal radiation
• Presence of Implantable Cardioverter Defibrillator (ICD) or pacemaker or other implanted electronic devices
• Abdominal pain suggesting an acute abdomen or obstruction. In clinical practice, only patients with crampy abdominal pain due to Crohn's disease, previous intestinal surgery and a previous history of radiation therapy require a patency capsule or CT enterography before capsule endoscopy.
• Patients who cannot undergo surgery

Where it is running

• University of Massachusetts Memorial Medical Center -- University Campus — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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