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PUCCINI Interim Reports – 2012

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

PI: Bruce Sands

Update:  November 2012

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Hypothesis:

IBD patients exposed to anti-TNF therapies pre-operatively have a higher rate of post-operative infections within 30 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

Status Update:

  • Pilot study sites (PI/Co-Investigator)
    • Cleveland Clinic Foundation (Bo Shen, Feza Remzi)
    • Massachussetts General Hospital (Vijay Yajnik, Liliana Bordeianou)
    • The Mount Sinai Hospital (Bruce Sands, Benjamin Cohen, Joel Bauer)
    • University of Michigan Hospital (Peter Higgins, Karin Hardiman)
    • University of North Carolina Hospitals (Hans Hefarth, Mark Koruda)
    • Electronic CRFs created by UNC/Dartmouth from detailed study protocol.
    • Patient recruitment began late September 2012.  53 patients enrolled as of October 22.
    • Pilot site conference calls including research coordinators, IBD gastroenterologists, and IBD. surgeons have been taking place every 2 weeks since August.  Calls have been used to modify enrollment strategies, trouble shoot electronic CRF forms, and prepare for larger grant submission.
    • Letter of intent submitted for CCFA Senior Research Award