Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal… (NCT02442830) | Clinical Trial Compass
CompletedNot Applicable
Comparing Early Capsule Deployment to Current Standard of Care for Management of Gastrointestinal Bleeding
United States87 participantsStarted 2015-04-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
What they're measuring
1
Time to Localization of Bleeding
Timeframe: Enrollment to localization of bleeding as measured in hours, up to 720 hours, whichever is sooner.