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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747068
• Other study ID #: 09-0218-E
• Status: Completed
• 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
• 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 .

Related Conditions & MeSH terms

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

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