Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-05 @ 2:25 AM
Study NCT ID:
NCT03747068
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2018-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-17', 'studyFirstSubmitDate': '2018-11-12', 'studyFirstSubmitQcDate': '2018-11-17', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the rectum, as increased rectal fibrosis may be a potential factor in adverse anastomosis complications following IPAA surgery', 'timeFrame': 'all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed', 'description': 'Assesment of the degree of fibrosis in the lamina propria, the subbmucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis', 'Anti TNF Therapy', 'Ileal Pouch Anal Anastomosis (IPAA)']}, 'descriptionModule': {'briefSummary': "BACKGROUND: Previous studies of short-term surgical outcomes after preoperative exposure to anti-TNF therapy in ulcerative colitis (UC) patients who have undergone IPAA have been conflicting. We sought to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the colorectum, which may be a potential factor in adverse anastomosis complications following IPAA surgery.\n\nMETHODS: Individuals who received infliximab as maintenance therapy and who received their last dose within 180 days of the first stage of IPAA were selected. The control group comprised UC patients who were not exposed to anti-TNF therapy, matched by age, sex, BMI, disease duration, albumin levels, and post-operative leak outcome. Hematoxylin and eosin- (H\\&E) and trichrome-stained slides from the most distal, well-oriented, full-thickness section of colorectum from each patient's total colectomy specimen were evaluated. Blinded assessment of the degree of fibrosis in the lamina propria, the submucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed. Patients with CD and those without adequate clinical records documenting the 30-day postoperative clinical outcomes were excluded', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed .\n\nExclusion Criteria:\n\n* Patients with CD\n* Patients without adequate clinical records documenting the 30-day postoperative clinical outcomes .'}, 'identificationModule': {'nctId': 'NCT03747068', 'briefTitle': 'The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Preoperative Use of ANTI-Tumor Necrosis Factor Therapy in Ulcerative Colitis Patients Who Underwent Ileal Pouch-Anal Anastomosis (IPAA) is Not Associated With Histological Fibrosis', 'orgStudyIdInfo': {'id': '09-0218-E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'anti-TNF', 'description': 'UC patients treated with maintenance anti-TNF therapy who underwent IPAA surgery', 'interventionNames': ['Drug: Anti-TNF Drug']}, {'label': 'CONTROL GROUP', 'description': 'UC patients who were not exposed to anti-TNF therapy'}], 'interventions': [{'name': 'Anti-TNF Drug', 'type': 'DRUG', 'armGroupLabels': ['anti-TNF']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of IBD unit', 'investigatorFullName': 'Eran Zittan', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}