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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative patients | Patients with CD who recently underwent bowel resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonic capsule endoscopy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of postoperative recurrence of CD |
| 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 |
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Inclusion Criteria:
Segmental bowel resection for Crohn's disease
Informed consent
Age ≥ 18 years
Exclusion Criteria:
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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. All patients have to give written informed consent before participating in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joerg G Albert, MD | Contact | +49696301 | 5297 | joerg.albert@kgu.de |
| Name | Affiliation | Role |
|---|---|---|
| Joerg G Albert, MD | Johann Wolfgang Goethe University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der JW Goethe Universität Frankfurt | Recruiting | Frankfurt am Main | Germany |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| Side effect of CCE and/or colonoscopy |
| Medizinische Hochschule Hannover | Not yet recruiting | Hanover | Germany |
| Universitaetsklnikum Leipzig | Not yet recruiting | Leipzig | Germany |
| Klinikum der Universität München - Campus Grosshadern | Not yet recruiting | München | Germany |
| D007410 | Intestinal Diseases |
| D013514 | Surgical Procedures, Operative |