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
Scientific
Medical Center Alkmaar
P.O. Box 500
Alkmaar
1800 AM
Netherlands
| Phone | +31 (0)72 548 3419 |
|---|---|
| b.m.wiarda@mca.nl |
Study information
| Study design | Prospective study comparing two imaging techniques |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Other |
| Study type | Screening |
| Scientific title | |
| Study acronym | COMRADE |
| Study objectives | 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(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) studied | Small bowel pathology |
| Intervention | 1. Magnetic resonance imaging (MRI) enteroclysis 2. Double ballon endoscopy 3. Video capsule |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/10/2006 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Medical Center Alkmaar
Alkmaar
1800 AM
Netherlands
1800 AM
Netherlands
Sponsor information
Schering Nederland BV (Netherlands)
Industry
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" |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
