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

HaEmek Medical Center, Israel

Status: Completed

Conditions: Ileal Pouch Anal Anastomosis (IPAA); Ulcerative Colitis; Anti TNF Therapy

Treatments: Drug: Anti-TNF Drug

Study type: Observational

Funder types: Other

Identifiers

NCT03747068

09-0218-E

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Volunteers: No 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 .

Trial design

130 participants in 2 patient groups

anti-TNF

Description:

UC patients treated with maintenance anti-TNF therapy who underwent IPAA surgery

Treatment:

Drug: Anti-TNF Drug

CONTROL GROUP

Description:

UC patients who were not exposed to anti-TNF therapy