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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03747068

Enrollment

130

Registered

2018-11-20

Start date

2009-10-09

Completion date

2015-10-09

Last updated

2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti TNF Therapy, Ileal Pouch Anal Anastomosis (IPAA), Ulcerative Colitis

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.

Interventions

DRUGAnti-TNF Drug

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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 .

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026