Condition category
Signs and Symptoms
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
24/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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 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 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

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

http://www.schering.nl/scripts/nl/index.php

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

Publication citations

Additional files

Editorial Notes