Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00886327
Status:
UNKNOWN
Last Update Posted:
2012-05-31
First Post:
2009-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detecting Postoperative Recurrence in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-30', 'studyFirstSubmitDate': '2009-04-21', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of postoperative recurrence of CD'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colonic capsule endoscopy', "Crohn's disease", 'Capsule endoscopy'], 'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nThis 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.\n\nIn 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.\n\nSample 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Segmental bowel resection for Crohn's disease\n\n * Ileocecal resection\n * Small bowel resection\n * Segmental colonic resection\n* Informed consent\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Intestinal obstruction as suspected by anamnesis or clinical/technical investigation\n* Dysphagia or ileus\n* Non-passage of the intact 'Agile Patency Capsule' within 72 hours\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT00886327', 'briefTitle': "Detecting Postoperative Recurrence in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': "Detection of Postoperative Recurrence of Crohn's Disease by Colonic Capsule-Endoscopy", 'orgStudyIdInfo': {'id': 'JWGUHMED1-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postoperative patients', 'description': 'Patients with CD who recently underwent bowel resection', 'interventionNames': ['Procedure: Colonic capsule endoscopy']}], 'interventions': [{'name': 'Colonic capsule endoscopy', 'type': 'PROCEDURE', 'armGroupLabels': ['Postoperative patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frankfurt am Main', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joerg Albert, MD', 'role': 'CONTACT', 'email': 'joerg.albert@kgu.de'}], 'facility': 'Klinikum der JW Goethe Universität Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Hanover', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Leipzig', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Universitaetsklnikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'München', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Klinikum der Universität München - Campus Grosshadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'centralContacts': [{'name': 'Joerg G Albert, MD', 'role': 'CONTACT', 'email': 'joerg.albert@kgu.de', 'phone': '+49696301', 'phoneExt': '5297'}], 'overallOfficials': [{'name': 'Joerg G Albert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johann Wolfgang Goethe University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Joerg Albert, MD', 'oldOrganization': 'Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main'}}}}