Detecting Postoperative Recurrence in Crohn's Disease

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00886327

Collaborator

(none)

Enrollment

Locations

Duration (Months)

17.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Procedure: Colonic capsule endoscopy

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Postoperative patients Patients with CD who recently underwent bowel resection	Procedure: Colonic capsule endoscopy

Arm

Intervention/Treatment

Postoperative patients

Patients with CD who recently underwent bowel resection

Procedure: Colonic capsule endoscopy

Outcome Measures

Primary Outcome Measures

Detection of postoperative recurrence of CD []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Klinikum der JW Goethe Universität Frankfurt	Frankfurt am Main	Germany
2	Medizinische Hochschule Hannover	Hannover	Germany
3	Universitaetsklnikum Leipzig	Leipzig	Germany
4	Klinikum der Universität München - Campus Grosshadern	München	Germany