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PUCCINI

PUCCINI: Prospective Cohort of Ulcerative Colitis and Crohn’s Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative INfection I

PI

Benjamin Cohen, Bruce Sands

Hypothesis

IBD patients exposed to anti-TNF therapies pre-operatively have a higher rate of post-operative infections within 90 days than patients not exposed to these medications.

Primary Objectives

  • Determine whether the rate of post-operative infection (surgical site infections and extra-abdominal infections) in a prospective multi-center sample of IBD patients undergoing abdominal surgery is greater in patients exposed to anti-TNF therapy than those unexposed to these medications.
  • Determine whether anti-TNF exposure is an independent risk factor for post-operative infection in a multi-center prospective sample of IBD patients undergoing abdominal surgery.
  • Secondary Objectives:
  • Determine if exposures to other IBD therapies including corticosteroids, antibiotics, thiopurines, methotrexate, cyclosporine, and natalizumab are associated with an increased rate of post-operative infection in a prospective multi-center sample of IBD patients undergoing abdominal surgery in the United States.
  • Determine other risk factors that predict post-operative infection in a prospective multi-center sample of IBD patients undergoing abdominal surgery in the United States.
  • Determine predictors of short term pouch specific complications in a prospective multi-center sample of IBD patients undergoing Ileal Pouch Anal Anastomosis (IPAA) in the United States.
  • Determine predictors of non-infectious outcomes such as hospital re-admission, re-operation, thrombotic complication, and mortality in a prospective multi-center sample of IBD patients undergoing abdominal surgery in the United States

This study will be piloted in 3-5 centers in 2012.

Interim Reports 2012

Interim Reports 2013

Interim Reports 2014