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



Status:Recruiting
Conditions:Colitis, Colitis, Irritable Bowel Syndrome (IBS), Infectious Disease, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:1/5/2017
Start Date:February 2014
End Date:June 2017
Contact:Benjamin Cohen, MD, MAS
Email:benjamin.cohen@mssm.edu
Phone:212-241-0150

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Prospective Cohort of Ulcerative Colitis and Crohn's Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I

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.

This is a prospective, multi-center, observational study designed to determine if
pre-operative exposure to anti-TNF agents is an independent risk factor for post-operative
infectious complications within 30 days of surgery in subjects with IBD.

Patient Assessments:

Patient assessments will occur at the Screening/Baseline Visit, Discharge Day, and 30-Day
Telephone Follow-up (see Figure 1). Potential pre-operative predictors of post-operative
infections will be assessed at the Screening/Baseline Visit through a brief patient
interview and abstraction of medical records. Data will be entered into the electronic case
report forms (eCRF). A second data abstraction will occur on the Discharge Day. At this
time, all data from the day of surgery will be available including finalized operative
reports, anesthesia records, and pathology. The post-operative medical record will also be
reviewed for potential confounding factors related to post-operative infection (i.e.
presence of central lines, foley catheters, antibiotic use, etc.). Additionally, the medical
record will be reviewed for the occurrence of post-operative infection and the other
non-infectious outcomes being studied. Data will be entered into the eCRF. The final
assessment will occur on post-operative day 30 (within 1 week). A telephone interview will
be conducted. The purpose of the interview is to assess for the occurrence of post-operative
infection and non-infectious outcomes. If an infection has been identified, relevant medical
records will be requested to confirm infection and abstract information pertaining to the
infection. Data will be entered into the eCRF.

Assessment of Anti-TNF Exposure:

Exposure to anti-TNF agents will be defined in two different ways. The primary analysis will
define anti-TNF exposure as patient report of use within 12 weeks of surgery
pre-operatively. Confirmation of patient report will be through medical record abstraction.
This definition of anti-TNF exposure is consistent with many of the retrospective, single
center studies on post-operative infections related to IBD surgery. The 12-week cutoff point
has been chosen to account for the washout of infliximab before surgery based on its
half-life. However, the different anti-TNF agents have varying half-lives. Date of last
administration prior to surgery will be recorded so that different cutoff points to define
exposure such as 4 weeks and 8 weeks may be explored.

The secondary analysis will define anti-TNF exposure by measured peri-operative levels in
patients with a history of anti-TNF use in the six months preceding surgery. Anti-TNF levels
and anti-drug antibodies will be checked at two time points in patients with recent anti-TNF
use. An initial level will be drawn at the screening visit, which may occur peri-operatively
up to post-op day 4. A second level will be drawn anytime between post-op day 4 and post-op
day 7. The serum from these blood draws will be stored at -80 Celsius until the third year
of the study at which time samples will be tested for drug levels and antibodies.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
24
sites
Urbana, Illinois 61801
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Vijay Yajnik, MD, PhD
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Sonia Friedman, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Russell Cohen, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Bo Shen, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Phillip Fleshner, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: Nicole Palekar, MD
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Peter Higgins, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
Principal Investigator: Mark Gerich, MD
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
Principal Investigator: Mark Flasar, MD
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Boston, Massachusetts 02118
Principal Investigator: Francis Farraye, MD, MSc
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Hans Hefarth, MD, PhD
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Cleveland, Ohio 44194
Principal Investigator: Jeffry Katz, MD
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3450 Hull Road
Gainesville, Florida 32610
Principal Investigator: Sarah Glover, DO
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Hershey, Pennsylvania 17033
Principal Investigator: Andrew Tinsley, MD, MS
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Corey A Siegel, MD, MS
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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New York, New York 10021
Principal Investigator: Burton Korelitz, MD
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Bruce Sands, MD, MS
Phone: 212-241-0150
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Mark Osterman, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Pittsburgh, Pennsylvania 15213
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Sunanda Kane, MD
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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San Francisco, California 94143
Principal Investigator: Uma Mahadevan-Velayos, MD
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Jonathan Leighton, MD
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Winston-Salem, North Carolina 27157
Principal Investigator: Jaime Bohl, MD
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