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.
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