Presentations

Abstract

Introduction: Cleft palate is a congenital condition that can lead to various respiratory complications due to the abnormal communication between the oral and nasal cavities which can pose significant respiratory challenges, including an increased risk of upper respiratory infections, otitis media with effusion, and obstructive sleep apnea. These complications are particularly concerning during surgical interventions like palatoplasty. The COVID-19 pandemic introduced new complexities in managing surgical cases, such as delay to procedure as well as difficulties in managing post-surgical care given pandemic protocols. However, there is limited research on how a past or perioperative COVID-19 infection affects the outcomes of cleft palate repair. To address this gap, we utilized the TriNetX database, which aggregates data from 127 national and international healthcare organizations, providing a large and diverse sample size necessary to study this issue in the pediatric population, where COVID-19 incidence is lower. This study primarily aims to determine whether a history of COVID-19 infection increases the risk of postoperative respiratory complications in cleft palate repair. The primary objective is to isolate COVID-19 as a risk factor, while the exploratory analysis considers the impact of pre-existing respiratory conditions, offering a comprehensive view of the factors that may contribute to postoperative complications.

Methods: Data were sourced from the TriNetX Global Collaborative Network, involving 127 healthcare organizations. The study included two cohorts: Cohort 1 (3,148 patients in the primary analysis and 3,117 patients in the exploratory analysis) with a history of COVID-19 infection undergoing palatoplasty, and Cohort 2 (15,348 patients in the primary analysis and 14,048 patients in the exploratory analysis) undergoing palatoplasty without prior COVID-19 infection. The primary analysis excluded outcomes prior to the index event to specifically assess the impact of COVID-19. An exploratory analysis was also conducted, including prior outcomes to examine the potential influence of pre-existing respiratory conditions.

Results: In the primary analysis excluding prior outcomes, respiratory complications occurred in 0.8% of patients in Cohort 1 and 0.5% in Cohort 2, with no statistically significant difference between the cohorts (Risk Ratio: 1.458, p=0.127). In the exploratory analysis, which included prior outcomes, the complication rate increased to 2.4% in Cohort 1 and 1.6% in Cohort 2, indicating a significant risk increase in the COVID-19 cohort (Risk Ratio: 1.489, p=0.002). Kaplan-Meier survival analysis revealed no significant difference in survival probability in the primary analysis (Log-Rank Test: p=0.133), while the exploratory analysis showed a significant difference (Log-Rank Test: p=0.003).

Conclusion: Excluding prior outcomes helps isolate the impact of COVID-19, suggesting no significant increase in postoperative respiratory complications directly attributable to COVID-19 alone. In contrast, including prior outcomes indicates a higher overall risk, potentially linked to pre-existing respiratory conditions. This finding underscores the importance of further analyses focusing on specific syndromic and respiratory diagnoses, as these may reveal additional factors contributing to postoperative complications beyond COVID-19.