Detecting Postoperative Recurrence in Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00886327
• Other study ID #: JWGUHMED1-001
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2009
• Last updated: May 30, 2012
• Start date: May 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2009
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: Joerg G Albert, MD
• Phone: +49696301
• Email: joerg.albert[@]kgu.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Procedure:
• Colonic capsule endoscopy

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of postoperative recurrence of CD			No
Secondary	Therapeutic intervention due to detection of recurrent CD			No
Secondary	Detection of small bowel lesions by CCE			No
Secondary	Rate of bowel stenosis as detected by PC			No
Secondary	Side effect of CCE and/or colonoscopy			Yes