BIOLOGICS BEFORE SURGERY FOR IBD - ARE THEY ASSOCIATED WITH POST-OPERATIVE INFECTIOUS OUTCOMES?
RESULTS FROM THE A NATIONAL SURGICAL QUALITY IMPROVEMENT PROGRAM INFLAMMATORY BOWEL DISEASE COLLABORATIVE IN >1500 PATIENTS
Stefan D. Holubar*1, Xue Jai1, Tracy L. Hull1, Neil Hyman4, Randolph Steinhagen5, Walter Koltun6, Liliana G. Bordeianou7, Hiroko Kunitake7, Edward C. Lee8, Evangelos Messaris9, matthew mutch3, Sonia Ramamoorthy2, Samuel Eisenstein2
1Cleveland Clinic Colorectal Surgery, Cleveland, OH; 2University of California San Diego, San Diego, CA; 3Washington University in Saint Louis, St. Louis, MO; 4University of Chicago, Chicago, IL; 5Mount Sinai, New York City, NY; 6University of Pennsylvania, Hersey, PA; 7Mass General Hosp / Harvard Medical School, Boston, MA; 8Albany Medical College, Albany, NY; 9Beth Israel Deaconess, Boston, MA
Background: We aimed to utilize the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) Inflammatory Bowel Disease (IBD) Collaborative, which includes disease-specific variables, to assess the association between preoperative biologic exposure and post-operative infectious complications in the largest cohort reported to date.
Methods: Data was obtained from ten IBD centers from 2017 - 2018. Univariate and multivariate analyses were performed, with any biologic use within 60-days of surgery as the primary predictor, adjusting for diagnosis, chronic steroid use, immunomodulator (IMM) use, ostomy construction, anemia, malnutrition, operative length, emergency surgery, and other variables with p<0.05 from the univariate analysis. The primary endpoint was any (composite) infectious complication, and the secondary endpoint was any (composite) surgical site infection.
Results: A total of 1,562 patients were included, of which 832 (53%) were not exposed to biologics, and 730 (47%) were exposed to biologics before surgery. The biologics group had more preoperative weight loss, lower albumin, more systemic sepsis, more IMM and steroid use, and more had Crohn’s disease (all p<0.001). The biologics group were also more likely to receive a new ostomy and to have a colectomy (vs. proctectomy or small bowel procedure), and fewer had elective surgery (all p<0.001). On univariate analysis (Table 1), compared with no biologic exposure, biologic exposure was not associated with any infectious complications, any surgical site infections, anastomotic leak after colectomy, or other post-operative outcomes, but was associated with increased rate of anastomotic leak after proctectomy (n=423), 6.7% vs. 1.9%, p=0.02. With respect to the primary and secondary outcomes, the results of the multivariate analyses are shown in Table 2. Biologics were shown not to be associated with any infectious complication (OR 0.88, 95%CI 0.54 – 1.42) or any surgical site infection (OR 0.77, 95% CI 0.46 – 1.28), while Crohn’s disease was associated with any infectious complications (OR 2.11 95% CI 1.12 – 4, p=0.02).
Conclusions: In the largest nationally representative retrospective cohort to date, we found that biologics exposure within 60-days of surgery for IBD, using well-validated methodology and after vigorous adjustment for disease- and surgery-specific covariates, was not associated with post-operative infectious or surgical site infectious complications.
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