Derivation of a clinical decision rule for predictive factors for the development of pharyngocutaneous fistula postlaryngectomy()()

INTRODUCTION: Pharyngocutaneous fistula after larynx and hypopharynx cancer surgery can cause several damages. This study's aim was to derive a clinical decision rule to predict pharyngocutaneous fistula development after pharyngolaryngeal cancer surgery. METHODS: A retrospective cohort study was conducted, including all patients performing total laryngectomy/pharyngolaryngectomy (n = 171). Association between pertinent variables and pharyngocutaneous fistula development was assessed and a predictive model proposed. RESULTS: American Society of Anesthesiologists scale, chemoradiotherapy, and tracheotomy before surgery were associated with fistula in the univariate analysis. In the multivariate analysis, only American Society of Anesthesiologists maintained statistical significance. Using logistic regression, a predictive model including the following was derived: American Society of Anesthesiologists, alcohol, chemoradiotherapy, tracheotomy, hemoglobin and albumin pre-surgery, local extension, N-classification, and diabetes mellitus. The model's score area under the curve was 0.76 (95% CI 0.64–0.87). The high-risk group presented specificity of 93%, positive likelihood ratio of 7.10, and positive predictive value of 76%. Including the medium-low, medium-high, and high-risk groups, a sensitivity of 92%, negative likelihood ratio of 0.25, and negative predictive value of 89% were observed. CONCLUSION: A clinical decision rule was created to identify patients with high risk of pharyngocutaneous fistula development. Prognostic accuracy measures were substantial. Nevertheless, it is essential to conduct larger prospective studies for validation and refinement.