Efficacy of Ventilation Tube Insertion with Palatal Repair for Otitis Media in Cleft Palate: Meta-Analysis and Trial Sequential Analysis

Cleft palate is the most common congenital facial deformity and may result in multiple sequelae and disabilities. One common comorbidity is refractory otitis media with effusion (OME), as patients with cleft palate have impaired eustachian tube function with alteration of the nearby muscular structures. Ventilation tube insertion (VTI) is regarded as an effective mean to address OME in addition to palatal repair surgery. However, controversy regarding the efficacy of VTI and the timing of VTI remains. We aimed to assess the efficacy of VTI with palatal repair for cleft palate on OME development via a meta-analysis with systematic review and trial sequential analysis (TSA). Studies including patients with cleft palate who underwent palatal repair with or without VTI were considered eligible. After searching the Cochrane Library, PubMed, EMBASE, Web of Science, Scopus and China National Knowledge Infrastructure (CNKI) from inception through 5 September 2021, 9 studies involving 929 patients were included. Overall, a significantly higher OME-free rate was noted in those who underwent VTI and palatal repair than in those who underwent palatal repair alone (OR, 2.73; 95% CI, 1.37 to 5.42; p = 0.004; I(2) = 84%). Subgroup analysis revealed that the OME-free rate remained higher in the concurrent VTI group (OR, 3.29; 95% CI, 1.64 to 6.59; p < 0.001; I(2) = 81%). TSA indicated that all the analyses provided conclusive results by meeting the required information size and Z-value. The meta-analysis indicated that VTI is an effective procedure to prevent OME in patients with cleft palate and that VTI is beneficial when performed concurrently with palatal repair surgery.