M. Crohn obscure gastrointestinal bleeding
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of >18 and
Exclusion criteria
Exclusion criteria: Patients will be excluded in case of: - Abdominal surgery in the 6 weeks prior to inclusion - Pregnancy - Breastfeeding - Inability to swallow the video capsule - Presence of a pacemaker or cardioversion device - Severe concomitant disease with limited life expectancy - A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diagnostic yield, including location and nature of lesions. The pathologic findings in the small bowel of the different diagnostic methods will be correlated with each other to analyse location and nature of lesions. This will assessed in two populations: 1. Patients with known or suspected Crohn*s disease. The findings of the two techniques will be compared to the double balloon endoscopy on these items: location, severity of Crohn*s activity, stenosis and complications 2. Patients with signs of chronic or repeated gastrointestinal bleeding with negative gastroscopy and colonoscopy. The findings of the two techniques will be compared to the double balloon endoscopy on these items: location of bleeding focus and characters of the lesion. The findings of the double balloon endoscopy will be used as the gold standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients* appreciation of the different diagnostic methods. This will be analysed by means of a questionnaire. The specific questions of each examination will be filled in before all examinations, 24 hours after the specific examination and 5 weeks after all the examinations. | — |
Countries
Netherlands