Small bowel imaging COmparing Magnetic Resonance enteroclysis and video cApsule with Double-balloon Endoscopy: the COMRADE study

ISRCTN ISRCTN78685405
DOI https://doi.org/10.1186/ISRCTN78685405
Secondary identifying numbers 0503; NTR774
Submission date
28/12/2006
Registration date
28/12/2006
Last edited
24/03/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr B M Wiarda
Scientific

Medical Center Alkmaar
P.O. Box 500
Alkmaar
1800 AM
Netherlands

Phone +31 (0)72 548 3419
Email b.m.wiarda@mca.nl

Study information

Study designProspective study comparing two imaging techniques
Primary study designInterventional
Secondary study designMulti-centre
Study setting(s)Other
Study typeScreening
Scientific title
Study acronymCOMRADE
Study objectivesComparison 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(s)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).
Health condition(s) or problem(s) studiedSmall bowel pathology
Intervention1. Magnetic resonance imaging (MRI) enteroclysis
2. Double ballon endoscopy
3. Video capsule
Intervention typeOther
Primary outcome measureDiagnostic 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 Crohn’s 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 measuresPatients’ 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 study start date01/10/2006
Completion date01/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Key inclusion criteria1. Patients of more than 18 and less than 75 years
2. One of the following patient groups:
2.1. Patients with suspected Crohn’s disease
2.2. Patients with Crohn’s 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2006
Date of final enrolment01/06/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Medical Center Alkmaar
Alkmaar
1800 AM
Netherlands

Sponsor information

Schering Nederland BV (Netherlands)
Industry

c/o Christiane Pering, M.D.
Van Houten Industriepark 1
Weesp
NL-1381
Netherlands

Website http://www.schering.nl/scripts/nl/index.php
ROR logo "ROR" https://ror.org/05y28vr04

Funders

Funder type

Research organisation

Foreest Institute (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan