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Detecting Postoperative Recurrence in Crohn's Disease

NCT ID: NCT00886327

Last Updated: 2012-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Crohn's Disease

Keywords

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Colonic capsule endoscopy Crohn's disease Capsule endoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Postoperative patients

Patients with CD who recently underwent bowel resection

Colonic capsule endoscopy

Intervention Type PROCEDURE

Interventions

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Colonic capsule endoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main

Principal Investigators

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Joerg G Albert, MD

Role: PRINCIPAL_INVESTIGATOR

Johann Wolfgang Goethe University Hospital

Locations

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Klinikum der JW Goethe Universität Frankfurt

Frankfurt am Main, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status NOT_YET_RECRUITING

Universitaetsklnikum Leipzig

Leipzig, , Germany

Site Status NOT_YET_RECRUITING

Klinikum der Universität München - Campus Grosshadern

München, , Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Joerg G Albert, MD

Role: CONTACT

Phone: +49696301

Email: [email protected]

Facility Contacts

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Joerg Albert, MD

Role: primary

Other Identifiers

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JWGUHMED1-001

Identifier Type: -

Identifier Source: org_study_id