Sandra Yin

November 11, 2011

November 11, 2011 (National Harbor/Washington, DC) — Researchers have developed a formula to help physicians decide whether a patient with inflammatory bowel disease (IBD) is a good candidate for surgery, according to findings presented here at the American College of Gastroenterology 2011 Annual Scientific Meeting and Postgraduate Course.

The formula generates a number that represents the predictive risk for a postsurgical complication in this patient population.

To create the predictive score, researchers at the University of Miami Miller School of Medicine, in Florida, identified risk factors associated with complications and built a score that's designed to be objective and useable in daily clinical practice. After designing the score, they evaluated it in a population of 91 IBD patients.

"The most important fact is that we were able to identify several variables that, when combined, have a pretty good chance of predicting those patients who develop complications after surgery," said principal investigator Andres Yarur, MD, a gastroenterology fellow at the University of Miami.

Having an objective way of measuring risk in people with IBD is extremely useful, he said, pointing out that in many cases, surgery is an option, not an absolute necessity.

Many surgical risk scores have been created for surgeries such as colon cancer and small bowel resection. But until now, there has been no score specific to people with IBD, Dr. Yarur told Medscape Medical News. Because they are quite different from the average population — for example, they tend to be malnourished — you can't use other surgical risk formulas.

The sample consisted of 91 patients undergoing nonemergent intra-abdominal IBD-related surgery from January 1998 to March 2011. The researchers considered the following variables in the predictive model: demographics, IBD phenotype, nutritional status, comorbidities, laboratory parameters, histologic findings, and medical treatment for IBD.

The primary outcome was the development of a postoperative medical or surgical complication, defined as wound infection or dehiscence, intra-abdominal abscess, anastomotic leak, urinary tract infection, pneumonia, deep venous thrombosis, or death. Secondary outcomes were length of postoperative inpatient stay, postoperative need for total parenteral nutrition, and admission to an intensive care unit.

The researchers identified the following risk factors associated with surgical morbidity: Crohn's disease/ulcerative colitis, age, creatinine, blood urea, sodium, potassium, and smoking.

Overall, 61% of the study population had Crohn's disease and 39% had ulcerative colitis. The researchers calculated the risk score by adding regression coefficients of variables that were found to be predictive in the analysis.

Identifying risk factors for surgical complications is important, according to James Lewis, MD, MSCE, chair elect of the Crohn's and Colitis Foundation of America's National Scientific Advisory Committee.

"Those risk factors that are reversible and in the causal pathway are opportunities to improve surgical outcomes," he told Medscape Medical News. "Developing predictive models is also important for risk adjustment in future studies examining care models that may reduce the risk of surgical complications."

Dr. Lewis, who is also associate director of the inflammatory bowel disease program at the University of Pennsylvania, Philadelphia, acknowledged that the study is relatively small and that it will be important to validate the findings in future studies. Some factors that might be associated with complications after surgery were not included in the final model, possibly because of the relatively small sample size, he said. Steroids, for example, have been associated with postoperative complications in many studies.

"The proof...is in the validation," Lloyd Mayer, MD, told Medscape Medical News. He is chair of the Crohn's and Colitis Foundation of America's National Scientific Advisory Committee and professor and codirector of the Immunology Institute at Mount Sinai Medical Center in New York City. "If it doesn't survive the validation test, then it is an index and nothing more."

The only way of assessing whether the predictor applies in other populations is for other people to try it out, Dr. Yarur noted.

Dr. Yarur has disclosed no relevant financial relationships. Dr. Lewis reports financial relationships with Roche, Amgen, Centocor, Dark Canyon Laboratories, Millennium Pharmaceuticals, Pfizer, Shire, Takeda, and United BioSource Corporation. Dr. Mayer reports financial relationships with Abbott, Centocor, Pfizer, and Takeda.

American College of Gastroenterology (ACG) 2011 Annual Scientific Meeting and Postgraduate Course: Abstract 58. Presented November 1, 2011.

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