Skip to content

Small bowel imaging COmparing MR Enteroclysis and Video CApsule with Double-Balloon Endoscopy; the COMRADE study

Small bowel imaging COmparing MR Enteroclysis and Video CApsule with Double-Balloon Endoscopy; the COMRADE study - The COMRADE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30347
Enrollment
80
Registered
2006-06-09
Start date
2006-10-01
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M. Crohn obscure gastrointestinal bleeding

Interventions

MR enteroclyse, dubbel ballon endoscopie, videocapsule

Sponsors

Medisch Centrum Alkmaar
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)