Detecting Postoperative Recurrence in Crohn's Disease

NCT00886327 | Unknown DMC

• 1 other identifier: JWGUHMED1-001
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 4

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).

Conditions

Crohn's Disease

Keywords

Colonic capsule endoscopy; Crohn's disease; Capsule endoscopy

Outcome Measures

Primary Outcomes (1)

• Detection of postoperative recurrence of CD

Secondary Outcomes (4)

• 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

Study Arms (1)

Postoperative patients

Patients with CD who recently underwent bowel resection

Procedure: Colonic capsule endoscopy

Interventions

Colonic capsule endoscopy PROCEDURE

Postoperative patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Segmental bowel resection for Crohn's disease
• Ileocecal resection
• Small bowel resection
• Segmental colonic resection
• Informed consent
• Age ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (4)

Klinikum der JW Goethe Universität Frankfurt

Frankfurt am Main, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, Germany

NOT YET RECRUITING

Universitaetsklnikum Leipzig

Leipzig, Germany

NOT YET RECRUITING

Klinikum der Universität München - Campus Grosshadern

München, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Joerg G Albert, MD

  Johann Wolfgang Goethe University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joerg G Albert, MD

CONTACT

+49696301; joerg.albert@kgu.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: May 31, 2012

Record last verified: 2009-04

Locations

DE (4)