Detecting Postoperative Recurrence in Crohn's Disease

May 30, 2012 updated by: Johann Wolfgang Goethe University Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt am Main, Germany
        • Recruiting
        • Klinikum der JW Goethe Universität Frankfurt
        • Contact:
      • Hannover, Germany
        • Not yet recruiting
        • Medizinische Hochschule Hannover
      • Leipzig, Germany
        • Not yet recruiting
        • Universitaetsklnikum Leipzig
      • München, Germany
        • Not yet recruiting
        • Klinikum der Universität München - Campus Grosshadern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Detection of postoperative recurrence of CD

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Joerg G Albert, MD, Johann Wolfgang Goethe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (Estimate)

April 22, 2009

Study Record Updates

Last Update Posted (Estimate)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWGUHMED1-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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