Detecting Postoperative Recurrence in Crohn's Disease

Study Overview
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Brief Summary
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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).

Official Title
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Detection of Postoperative Recurrence of Crohn's Disease by Colonic Capsule-Endoscopy

Conditions
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Crohn's Disease

Intervention / Treatment
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* Procedure: Colonic capsule endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Segmental bowel resection for Crohn's disease Ileocecal resection Small bowel resection Segmental colonic resection Informed consent Age ≥ 18 years Exclusion Criteria: Intestinal obstruction as suspected by anamnesis or clinical/technical investigation Dysphagia or ileus Non-passage of the intact 'Agile Patency Capsule' within 72 hours Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postoperative patients<br>Patients with CD who recently underwent bowel resection | Procedure: Colonic capsule endoscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of postoperative recurrence of CD |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic capsule endoscopy, Crohn's disease, Capsule endoscopy