Department of Head and Neck Surgery & Communication Sciences, Duke University School of Medicine, Durham, North Carolina.
Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina.
JAMA Otolaryngol Head Neck Surg. 2021 Nov 1;147(11):966-973. doi: 10.1001/jamaoto.2021.2433.
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.
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.
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.
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.
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.
咽皮瘘（PCF）是全喉切除术后的一种严重并发症。尽管 PCF 的临床危险因素及其与生活质量差有关已得到充分描述，但关于可能与此并发症相关的非临床因素的数据却很少。
确定非临床危险因素（例如年龄、性别、种族和民族）是否与全喉切除术后 PCF 的发生风险增加有关，以及重建方法是否解释了任何发现的差异。
设计、地点和参与者：本回顾性多中心队列研究使用了全国性验证、风险调整、基于结果、手术质量改进数据库（国家手术质量改进计划）中的数据，以检查 2005 年至 2018 年间接受全喉切除术患者的结局。从 2005 年 1 月 1 日至 2018 年 12 月 31 日对数据库进行了查询；数据分析于 2020 年 9 月 1 日至 2021 年 3 月 31 日进行。
主要结局是全喉切除术后 30 天内发生 PCF。分析了患者特征，包括年龄、性别、种族和民族、合并症以及重建方式。
在研究期间，有 1573 名成年患者（中位数年龄[IQR]，63[56-71]岁；1280[81.4%]为男性；293[18.6%]为女性；1001[63.6%]为非西班牙裔白人）接受了全喉切除术，并纳入了分析。总体 PCF 发生率为 4.3%（68 例/1573 例患者）。西班牙裔患者的 PCF 发生率最高（9.5%；9/95 例），是非西班牙裔白种人（3.8%；38/1001 例）和非西班牙裔黑种人（4.7%；11/236 例）的两倍多。在调整了临床和其他协变量后，与男性相比，女性发生 PCF 的可能性高 1.9 倍（调整后的优势比，1.90；95%CI，1.08-3.35）。我们还发现，与非西班牙裔白人患者相比，西班牙裔患者发生 PCF 的可能性高 3 倍（调整后的优势比，2.96；95%CI，1.36-6.47）。在控制了临床危险因素后，年龄或种族和民族之间的重建类型没有差异。
这项多中心队列研究发现，2 个非临床危险因素-西班牙裔和女性-与 PCF 形成风险增加有关。在患者-医生决策以及减少喉切除术后 PCF 形成率的未来干预措施中，应考虑这些风险因素。
