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Study to Determine Risk Factors for Post-operative Infection in Inflammatory Bowel Disease
NCT02054533 · View on ClinicalTrials.gov ↗
Study Summary
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 measurem
Conditions Studied
Study Locations (20)
Massachusetts
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital, Inc. — Boston
- Boston Medical Center — Boston
California
- Cedars-Sinai Medical Center — Los Angeles
- University of California San Francisco — San Francisco
Florida
- University of Florida College of Medicine — Gainesville
- Cleveland Clinic Florida — Weston
Illinois
- The University of Chicago — Chicago
- Carle Foundation Hospital — Urbana
New York
- Icahn School of Medicine at Mount Sinai — New York
- Lenox Hill Hospital — New York
North Carolina
- University of North Carolina — Chapel Hill
- Wake Forest School of Medicine — Winston-Salem
Arizona
- Mayo Clinic Arizona — Scottsdale
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 974 participants |
| Start Date | 2014-02 |
| Est. Completion | 2017-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02054533
The ClinicalTrials.gov registry entry for NCT02054533 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 974 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 946 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02054533 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Massachusetts, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02054533 about?
NCT02054533 is a clinical study titled "Study to Determine Risk Factors for Post-operative Infection in Inflammatory Bowel Disease". 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-T...
What is the current status of trial NCT02054533?
This trial is currently completed. The enrollment target is 974 participants. The study started on 2014-02. Estimated completion is 2017-06-30.
What conditions does trial NCT02054533 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT02054533?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 946 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02054533 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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