Trials / Completed
CompletedNCT03747068
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 130 (actual)
- Sponsor
- HaEmek Medical Center, Israel · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anti-TNF Drug |
Timeline
- Start date
- 2009-10-09
- Primary completion
- 2015-10-09
- Completion
- 2015-10-09
- First posted
- 2018-11-20
- Last updated
- 2018-11-20
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03747068. Inclusion in this directory is not an endorsement.