N/A N=87 Randomized Diagnostic

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

Melena · Gastrointestinal Hemorrhage

Bottom Line

View on ClinicalTrials.gov: NCT02442830 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Time to Localization of Bleeding — 21; 16 hours — p=.002

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Early Video Capsule Endoscopy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Massachusetts, Worcester
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Localization of Bleeding	21; 16	.002 sig
SECONDARY Number of Participants With Localization of Bleeding by the End of Admission	27; 15	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02442830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.