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

Completed

Conditions studied: Crohn's Disease, Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT02054533

Run by

Icahn School of Medicine at Mount Sinai

People needed

974

Starts

2014-02-01

Expected to finish

2017-06-30

Last updated by the study team

2017-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older;
• Diagnosis of CD, UC, or indeterminate colitis by standard criteria;
• Patient planned to have intra-abdominal surgery or has had intra-abdominal surgery in the preceding four days;
• Ability to provide written informed consent.

You may not qualify if…

• Current enrollment in a clinical trial for an investigational IBD therapy;
• Surgery to repair a complication from a recent surgery (≤ 90 days);
• Inability or unwillingness to provide written informed consent;
• Any other condition which may impede competence or compliance or hinder completion of the study in the opinion of the investigator.

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• The University of Chicago — Chicago, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital, Inc. — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Penn State College of Medicine — Hershey, Pennsylvania, United States
• The University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburth — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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