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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03747068
Other study ID # 09-0218-E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 9, 2009
Est. completion date October 9, 2015

Study information

Verified date November 2018
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date October 9, 2015
Est. primary completion date October 9, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Anti-TNF Drug


Locations

Country Name City State
n/a

Sponsors (3)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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