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PUCCINI Interim Reports – 2013

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

PI: Bruce Sands

Update:  April 2013

Rationale:

Surgery is common in both Crohn’s disease (CD) and ulcerative colitis (UC).  There is controversy within the literature as to what the risk factors are for post-operative complications in IBD patients. One of the central questions for which the current literature is heterogeneous is whether use of anti-TNF agents peri-operatively poses a risk for infectious and non-infectious complications.  The treatment paradigm for both CD and UC has shifted towards early control of disease with immunosuppressive agents, particularly anti-TNF agents. If anti-TNF agents are found to pose a risk for post-operative complications the management of IBD patients in the peri-operative period would need to be changed.

Hypothesis:

The primary hypothesis is that peri-operative anti-TNF exposure is an independent risk factor for 30 day incidence of post-operative infection in intra-abdominal surgery for CD and UC.

Aims:

Aim 1:    Determine whether exposure to anti-TNF agents is an independent risk factor for post-operative infection in intra-abdominal surgery for CD and UC

  1. Explore use of peri-operative anti-TNF drug levels as a measure of risk for post-operative infection

Aim 2:    Determine whether exposure to anti-TNF agents is an independent risk factor for important non-infectious post-operative outcomes in intra-abdominal surgery for CD and UC such as ileus/small bowel obstruction, thromboembolic event, reoperation, and mortality

  1. Explore use of peri-operative anti-TNF drug levels as a measure of risk for non-infectious post-operative outcomes

Aim 3:    To determine other risk factors associated with post-operative infection in IBD patients undergoing intra-abdominal surgery and explore analytic morphomic measurements as novel predictors of post-operative outcomes

Status Update:

  • The pilot study has been conducted at Cleveland Clinic Foundation, Massachussetts General Hospital, the Mount Sinai Hospital, University of Michigan Hospital, and University of North Carolina Hospitals over the last year. Approximately 150 patients have been enrolled.