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

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Completed

CT.gov ID

NCT03747068

Collaborator

Mount Sinai Hospital, Canada (Other), University of Toronto (Other)

130

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Anti TNF Therapy Ileal Pouch Anal Anastomosis (IPAA)	Drug: Anti-TNF Drug

Study Design

Study Type:

Observational

Actual Enrollment :

130 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 9, 2009

Actual Primary Completion Date :

Oct 9, 2015

Actual Study Completion Date :

Oct 9, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

HaEmek Medical Center, Israel
Mount Sinai Hospital, Canada
University of Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eran Zittan, Director of IBD unit, HaEmek Medical Center, Israel

ClinicalTrials.gov Identifier:

NCT03747068

Other Study ID Numbers:

09-0218-E

First Posted:

Nov 20, 2018

Last Update Posted:

Nov 20, 2018

Last Verified:

Nov 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Ulcer

Study Results

No Results Posted as of Nov 20, 2018