Clinical trial NCT00886327: Detecting Postoperative Recurrence in Crohn's Disease
Official title: Detection of Postoperative Recurrence of Crohn's Disease by Colonic Capsule-Endoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn's Disease
Keywords: Colonic capsule endoscopy
Crohn's disease
Capsule endoscopy
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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

Primary outcomes:
measure: Detection of postoperative recurrence of CD
Secondary outcomes:
measure: Therapeutic intervention due to detection of recurrent CD
measure: Detection of small bowel lesions by CCE
measure: Rate of bowel stenosis as detected by PC
measure: Side effect of CCE and/or colonoscopy
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum der JW Goethe Universität Frankfurt
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Universitaetsklnikum Leipzig
city: München
country: Germany
facility: Klinikum der Universität München - Campus Grosshadern
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Joerg G Albert, MD
role: PRINCIPAL_INVESTIGATOR
References: