The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.
NCT ID: NCT03747068
Last Updated: 2018-11-20
Study Results
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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COMPLETED
130 participants
OBSERVATIONAL
2009-10-09
2015-10-09
Brief Summary
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METHODS: 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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anti-TNF
UC patients treated with maintenance anti-TNF therapy who underwent IPAA surgery
Anti-TNF Drug
CONTROL GROUP
UC patients who were not exposed to anti-TNF therapy
No interventions assigned to this group
Interventions
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Anti-TNF Drug
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients without adequate clinical records documenting the 30-day postoperative clinical outcomes .
ALL
No
Sponsors
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Mount Sinai Hospital, Canada
OTHER
University of Toronto
OTHER
HaEmek Medical Center, Israel
OTHER
Responsible Party
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Eran Zittan
Director of IBD unit
Other Identifiers
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09-0218-E
Identifier Type: -
Identifier Source: org_study_id
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