Crohn's Disease Clinical Trial
Official title:
Detection of Postoperative Recurrence of Crohn's Disease by Colonic Capsule-Endoscopy
Up to ¾ of patients who have been diagnosed with Crohn's disease (CD) will have to undergo
bowel resection during their lifetime despite modern medical therapies. Unfortunately,
disease recurrence is common and endoscopic detection of recurring inflammation precedes
clinical relapse. Endoscopic investigation is therefore recommended to manage these
patients.
This multi center, prospective study compares the conventional endoscopic method,
ileo-colonoscopy to a new technique, i.e., colonic capsule endoscopy (CCE). CCE enables
investigation of the small bowel and the large intestines by using a double-sided video
camera with about 10 hours acquisition time.
This study aims to evaluate the performance of CCE to detect postoperative recurrence of CD
and detection rate of colonic and anastomotic recurrence is compared to ileo-colonoscopy.
Proximal (small bowel) lesions are additionally recorded and impact on clinical management
of the findings is accounted for. Moreover, safety aspects and influence of the findings on
progress of the disease are monitored. All consecutive patients who are operated for CD in
any of the participating study centers are eligible. Included are patients with segmental
small bowel, ileocecal or segmental colonic resection.
In some cases capsule retention has been reported at an average of 2-3% with CD patients at
elevated risk. Therefore, patency capsule is performed before application of the video CCE
to exclude bowel obstruction.
Sample size estimation results in n = 70, requiring each 140 capsule endoscopes and 140
patency capsules for performance of postoperative screening (ca 4-8 weeks postoperatively)
and detection of postoperative recurrence (ca 4-8 months postoperatively).
n/a
Observational Model: Cohort, Time Perspective: Prospective
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