Detecting Postoperative Recurrence in Crohn's Disease
Recruitment status was: Recruiting
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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Detection of Postoperative Recurrence of Crohn's Disease by Colonic Capsule-Endoscopy|
- Detection of postoperative recurrence of CD
- Therapeutic intervention due to detection of recurrent CD
- Detection of small bowel lesions by CCE
- Rate of bowel stenosis as detected by PC
- Side effect of CCE and/or colonoscopy
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Patients with CD who recently underwent bowel resection
|Procedure: Colonic capsule endoscopy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886327
|Klinikum der JW Goethe Universität Frankfurt|
|Frankfurt am Main, Germany|
|Medizinische Hochschule Hannover|
|Klinikum der Universität München - Campus Grosshadern|
|Principal Investigator:||Joerg G Albert, MD||Johann Wolfgang Goethe University Hospital|