Title: Professor of Medicine
Medical School
Gastroenterology, University of Chicago, Chicago, IL
Rush Medical College, Chicago, IL

Internship
Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL

Residency
Internal Medicine, Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL

Certifications
American Board of Internal Medicine - Internal Medicine
American Board of Internal Medicine - Gastroenterology

Academic Rank
Professor of Medicine

Professional Highlights
• Chair, Patient Education Committee, Crohn's and Colitis Foundation of America, 2008-2011
• Chair, Women's Committee of the American College of Gastroenterology, 2004-2008
• Member, Board of Trustees American College of Gastroenterology, 2007-2010

Mayo Clinic in Rochester
200 First St. S.W.
Rochester, MN 55905
General Number: 507-284-2511

Gastroenterology and Hepatology at Mayo Clinic specializes in the prevention, diagnosis and treatment of diseases of the digestive tract and liver. It is the largest practice of its kind in the United States. In any given year, members of the Division perform approximately 30,000 minimally invasive, endoscopic procedures in state-of-the-art facilities.

Through a divisional infrastructure organized around interest groups oriented toward disease processes, organ systems, procedures or patient groups, clinical expertise is integrated with the newest forms of established and experimental diagnostic and therapeutic methods. Outpatients and patients in the hospital are cared for by teams of physicians and allied health personnel with broad expertise in all forms of gastroenterological and hepatobiliary diseases.

Because of our recognition that high-quality care depends upon scientific discovery, major research programs at the basic, applied, and translational levels exist to generate new knowledge that ultimately benefits patients.

Mayo Clinic in Rochester, Minn., ranks No. 1 for digestive disorders in the U.S. News & World Report Best Hospitals rankings. Mayo Clinic in Scottsdale, Ariz., and in Jacksonville, Fla., are ranked among the Best Hospitals for digestive disorders by U.S. News & World Report. Mayo Clinic also ranks among the Best Children's Hospitals for digestive disorders.

 Study to Determine Risk Factors for Post-operative Infection in Inflammatory Bowel Disease (PUCCINI)

Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications near the time of surgery may affect patients' risks of infection or other post-operative complications. The only available studies on this topic have given conflicting results. These studies have been limited by the fact that they have been small in size and retrospective. Retrospective studies primarily involve chart review as the method of identifying potential risk factors for infections and other complications after they have already occurred. This method limits both the type and quality of information/data that can be collected. The conflicting results have led to variance in practice patterns with regards to management of anti-TNF agents, the timing of surgery, and even the types of surgery.

By enrolling patients at the time of their surgery, collecting extensive information may be possible than previously studied on potential risk factors for both infectious and non-infectious complications following surgery. Risk factors to be studied will include individual patient characteristics, disease characteristics, surgical methods, novel characteristics of CT scans and MRIs and extensive medication exposures. The primary objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of drug levels at the time of surgery has never been utilized in this way to evaluate the risk of anti-TNF agents in IBD. However, this has been done to assess the risk of other medications in different diseases.

If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD patients undergoing surgery, change maybe needed in the way these medications are used around the time of surgery. Additionally, by collecting comprehensive information on other potential risk factors besides medication use patients at greatest risk for bad outcomes can be identified and take protective measures when possible. The aims of this study address the CCFA challenge to better define the risks of medical and surgical therapies to improve the quality of care of IBD patients undergoing surgery.

Estimated Enrollment: 1000
Study Start Date: February 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)