The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.

November 17, 2018 updated by: Eran Zittan, HaEmek Medical Center, Israel

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

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed .

Exclusion Criteria:

  • Patients with CD
  • Patients without adequate clinical records documenting the 30-day postoperative clinical outcomes .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
anti-TNF
UC patients treated with maintenance anti-TNF therapy who underwent IPAA surgery
Drug: Anti-TNF Drug
CONTROL GROUP
UC patients who were not exposed to anti-TNF therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed
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.
all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Collaborators

University of Toronto
Mount Sinai Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2009

Primary Completion (Actual)

October 9, 2015

Study Completion (Actual)

October 9, 2015

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 17, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 17, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0218-E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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