Detecting Postoperative Recurrence in Crohn's Disease

• Conditions: Crohn's Disease
• Interventions: Procedure: Colonic capsule endoscopy

• Registration Number: NCT00886327
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-04
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Study Start: 2009-05
• Last Update Submitted: 2012-05-30
• Last Update Posted: 2012-05-31
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postoperative patients	Colonic capsule endoscopy	Patients with CD who recently underwent bowel resection

Primary Outcome Measures

Name	Time	Method
Detection of postoperative recurrence of CD

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Klinikum der JW Goethe Universität Frankfurt; 🇩🇪 Frankfurt am Main, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitaetsklnikum Leipzig; 🇩🇪 Leipzig, Germany

Klinikum der Universität München - Campus Grosshadern; 🇩🇪 München, Germany