Prospective Cohort of Ulcerative Colitis and Crohn s Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I
Phoenix/Scottsdale, Ariz., Rochester, Minn.
Trial status: Open for Enrollment
Why is this study being done?
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 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.
Who is eligible to participate?
- 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.
- 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.