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

Completed

• Conditions: Anti TNF Therapy; Ileal Pouch Anal Anastomosis (IPAA); Ulcerative Colitis
• Interventions: Drug: Anti-TNF Drug

• Registration Number: NCT03747068
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-09
• Primary Completion: 2015-10-09
• Study Completion: 2015-10-09
• Status Verified: 2018-11
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-17
• Last Update Submitted: 2018-11-17
• Study First Posted: 2018-11-20
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
anti-TNF	Anti-TNF Drug	UC patients treated with maintenance anti-TNF therapy who underwent IPAA surgery

Primary Outcome Measures

Name	Time	Method
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.