Detecting Postoperative Recurrence in Crohn's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00886327
First received: April 21, 2009
Last updated: May 30, 2012
Last verified: April 2009
  Purpose

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 Intervention
Crohn's Disease
Procedure: Colonic capsule endoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Postoperative Recurrence of Crohn's Disease by Colonic Capsule-Endoscopy

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Detection of postoperative recurrence of CD [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Therapeutic intervention due to detection of recurrent CD [ Designated as safety issue: No ]
  • Detection of small bowel lesions by CCE [ Designated as safety issue: No ]
  • Rate of bowel stenosis as detected by PC [ Designated as safety issue: No ]
  • Side effect of CCE and/or colonoscopy [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: May 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Postoperative patients
Patients with CD who recently underwent bowel resection
Procedure: Colonic capsule endoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886327

Contacts
Contact: Joerg G Albert, MD +49696301 ext 5297 joerg.albert@kgu.de

Locations
Germany
Klinikum der JW Goethe Universität Frankfurt Recruiting
Frankfurt am Main, Germany
Contact: Joerg Albert, MD       joerg.albert@kgu.de   
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Germany
Universitaetsklnikum Leipzig Not yet recruiting
Leipzig, Germany
Klinikum der Universität München - Campus Grosshadern Not yet recruiting
München, Germany
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Joerg G Albert, MD Johann Wolfgang Goethe University Hospital
  More Information

No publications provided

Responsible Party: Joerg Albert, MD, Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main
ClinicalTrials.gov Identifier: NCT00886327     History of Changes
Other Study ID Numbers: JWGUHMED1-001
Study First Received: April 21, 2009
Last Updated: May 30, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Colonic capsule endoscopy
Crohn's disease
Capsule endoscopy

Additional relevant MeSH terms:
Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014