Risk factor analysis in a contemporary cystectomy cohort using standardized reporting methodology and adverse event criteria.

PURPOSE: Adverse event reporting is poorly classified and nonstandardized in the urological literature. We report adverse event data and associated risk factors using standardized reporting methods and Common Terminology Criteria for Adverse Events, version 3.0 to minimize interpretation bias and allow reliable comparisons with other populations.
MATERIALS AND METHODS: We retrospectively reviewed consecutive radical cystectomies done for urothelial bladder carcinoma at our institution between January 2004 and September 2006. Adverse events within 90 days postoperatively were recorded. We explored the association of important risk factors with the overall complication rate and specific complications.
RESULTS: A total of 283 patients were included in the study. Complete 90-day followup data were available on 90% of patients. Median age was 70 years (IQR 62-75). Median body mass index was 26.8 kg/m(2) (IQR 24.4-31.0). At least 1 adverse event was observed in 152 patients (54.0%) and a grade 3-4 adverse event was observed in 40.3%. The most common grade 4 adverse events were myocardial infarction in 3.5% of cases, septic shock in 2.8% and pulmonary embolism in 1.8%. No patient died during followup. An association between body mass index, and any and major adverse events was found after adjusting for confounding variables.
CONCLUSIONS: More than 50% of patients experience an adverse event after radical cystectomy and 40% are major. Body mass index is independently associated with adverse events in these patients. These findings are important for individualized risk assessment, patient counseling and uniform assessment of quality care. 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.