Tensor Veli Palatini Muscle Tenopexy During Furlow Palatoplasty Fails to Improve Otologic Outcomes: A Randomized Clinical Trial.

ObjectiveTo determine whether tensor veli palatini muscle (mTVP) tenopexy performed during furlow palatoplasty (FP) reduces the occurrence of otitis media with effusion (OME) in children with cleft palate.DesignParent- and assessor-blinded randomized controlled trial.SettingsTertiary clinical care institution.PatientsIn total, 81 nonsyndromic children with cleft palate Veau I-IV were randomized to undergo traditional FP or FP with mTVP tenopexy (modified FP [MFP]). Middle ear status was evaluated longitudinally between 2 and 7 years of age.InterventionsFP with or without mTVP tenopexy.Main Outcome MeasuresPresence of OME after extrusion of ventilation tubes (VTs).ResultsThe mean age at palatoplasty was similar between groups (FP: 1.05 ± 0.17 years; MFP: 1.07 ± 0.18 years; p = .585). Baseline characteristics, including sex, race, preoperative OME, and Veau classification were comparable. Rates of additional surgical interventions (cheiloplasty, revision palatoplasty, alveolar bone graft, adenoidectomy, VT reinsertion, and tympanoplasty) did not differ between groups. The frequency of OME from ages 2 to 7 years was similar when analyzed by child (p = .09-.90), by ear (p = .145-.96), or using cumulative incidence (χ2 = 0.324; p = .569).ConclusionsIn this first randomized, blinded clinical trial evaluating mTVP tenopexy during FP, no improvement in the frequency or cumulative incidence of OME was observed. Given the absence of benefit and the additional operative time and cost, mTVP tenopexy is not recommended.ClinicalTrials.gov IDNCT01535131.