Contact information
Type
Scientific
Primary contact
Dr B M Wiarda
ORCID ID
Contact details
Medical Center Alkmaar
P.O. Box 500
Alkmaar
1800 AM
Netherlands
+31 (0)72 548 3419
b.m.wiarda@mca.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0503; NTR774
Study information
Scientific title
Acronym
COMRADE
Study hypothesis
Comparison of two new techniques for detection of small bowel pathology: magnetic resonance (MR) enteroclysis and videocapsule enteroscopy with double-balloon enteroscopy with respect to diagnostic yield, accuracy of findings, and patient preference.
Please note that as of 02/10/2008 the anticipated end date was extended. The initial anticipated end date was 01/10/2008. As of 06/02/2009 the anticipated end date was again extended. The previous anticipated end date was 01/01/2009. As of 24/03/2009 inclusion to this trial is closed.
Ethics approval
Approval received from:
1. The Medical Ethics Review Board (Medische Ethische Toetsingcommissie Noord-Holland ) on the 9 June 2006 (ref: M06-023).
2. The Medical Ethics Review Board (Medische Ethische Toetsingcommissie Erasmus Medical Center Rotterdam) on the 10th October 2006 (ref: MEC-2006-178).
Study design
Prospective study comparing two imaging techniques
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Other
Trial type
Screening
Patient information sheet
Condition
Small bowel pathology
Intervention
1. Magnetic resonance imaging (MRI) enteroclysis
2. Double ballon endoscopy
3. Video capsule
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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. For patients with known or suspected Crohns disease of the small bowel, a comparison will be made for prevalence, location, severity of inflammatory lesions, and complications such as formation of stenotic lesions. For patients with gastrointestinal blood loss, the techniques will be compared for prevalence and location of bleeding foci and characters of the lesion. The findings at the double balloon endoscopy will be used as the gold standard.
Secondary outcome measures
Patients appreciation of the different diagnostic methods. This will be analysed by means of a questionnaire. Patients will be asked to repeatedly fill out the same questionnaire, 24 hours before and after each examination and five weeks after all the examinations.
Overall trial start date
01/10/2006
Overall trial end date
01/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients of more than 18 and less than 75 years
2. One of the following patient groups:
2.1. Patients with suspected Crohns disease
2.2. Patients with Crohns disease, in need of visualisation of the small bowel because of suspected disease activity
2.3. Patients with signs of chronic or repeated gastrointestinal bleeding with negative gastroscopy and colonoscopy
3. Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Patients with suspected intra-abdominal abscess
2. Abdominal surgery in the six weeks prior to inclusion
3. Patients with clinical suspicion of high grade small bowel obstruction
4. Pregnancy
5. Breastfeeding
6. Inability to swallow the video capsule
7. Presence of a pacemaker or cardioversion device
8. Patients with a history of contrast media reaction and history of allergy (especially asthma)
9. Severe concomitant disease with limited life expectancy
10. A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study
Recruitment start date
01/10/2006
Recruitment end date
01/06/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Medical Center Alkmaar
Alkmaar
1800 AM
Netherlands
Sponsor information
Organisation
Schering Nederland BV (Netherlands)
Sponsor details
c/o Christiane Pering
M.D.
Van Houten Industriepark 1
Weesp
NL-1381
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Research organisation
Funder name
Foreest Institute (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary