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

NCT03747068 | Completed FDA Drug

• 1 other identifier: 09-0218-E
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

anti-TNF

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

Drug: Anti-TNF Drug

CONTROL GROUP

UC patients who were not exposed to anti-TNF therapy

Interventions

Anti-TNF Drug DRUG

anti-TNF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed. Patients with CD and those without adequate clinical records documenting the 30-day postoperative clinical outcomes were excluded

You may qualify if:

• all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed .

You may not qualify if:

• Patients with CD
• Patients without adequate clinical records documenting the 30-day postoperative clinical outcomes .

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• Mount Sinai Hospital, Canada: collaborator
• University of Toronto: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of IBD unit

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 20, 2018
• Study Start: October 9, 2009
• Primary Completion: October 9, 2015
• Study Completion: October 9, 2015
• Last Updated: November 20, 2018

Record last verified: 2018-11