Abstract
IMPORTANCE: Pharyngocutaneous fistula (PCF) is a serious complication after total laryngectomy. Despite the well-described clinical risk factors for PCF and its association with poor quality of life, there is a paucity of data on the nonclinical factors that may be associated with this complication. OBJECTIVE: To determine whether nonclinical risk factors (eg, age, sex, race and ethnicity) are associated with an increased risk of developing a PCF after total laryngectomy, and whether or not the method of reconstruction explains any differences found. DESIGN, SETTING, AND PARTICIPANTS: This retrospective multicenter cohort study used data from a nationally validated, risk-adjusted, outcomes-based, surgical quality improvement database (the National Surgical Quality Improvement Program) to examine outcomes in patients who underwent a total laryngectomy from 2005 to 2018. The database was queried from January 1, 2005, to December 31, 2018; data analyses were performed from September 1, 2020, to March 31, 2021. MAIN OUTCOMES AND MEASURES: The primary outcome was development of a PCF within 30 days of a total laryngectomy. Patient characteristics, including age, sex, race and ethnicity, comorbidities, and mode of reconstruction, were analyzed. RESULTS: A cohort of 1573 adult patients (median age [IQR], 63 [56-71] years; 1280 [81.4%] men; 293 [18.6%] women; 1001 [63.6%] non-Hispanic White individuals) had undergone a total laryngectomy during the study period and were included in the analyses. The overall rate of PCF formation was 4.3% (68 of 1573 patients). Hispanic patients had the highest rate (9.5%; 9 of 95 patients) of PCF formation, which was more than twice the rate among non-Hispanic White patients (3.8%; 38 of 1001) and non-Hispanic Black patients (4.7%; 11 of 236). After adjusting for clinical and other covariates, women were 1.9 times more likely to develop a PCF compared with men (adjusted odds ratio, 1.90; 95% CI, 1.08-3.35). We also found that the odds of developing a PCF were 3-fold higher among Hispanic patients compared with non-Hispanic White patients (adjusted odds ratio, 2.96; 95% CI, 1.36-6.47). The type of reconstruction did not differ across age or race and ethnicity after controlling for clinical risk factors. CONCLUSIONS AND RELEVANCE: This multicenter cohort study found that 2 nonclinical risk factors-Hispanic ethnicity and female sex-were associated with an increased risk of PCF formation. Knowledge of these risk factors should be included in patient-physician decision-making as well as future interventions to decrease the rate of PCF formation after laryngectomy.