Work

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

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Objective To 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. Design Parent- and assessor-blinded randomized controlled trial. Settings Tertiary clinical care institution. Patients In 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. Interventions FP with or without mTVP tenopexy. Main Outcome Measures Presence of OME after extrusion of ventilation tubes (VTs). Results The 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 (χ 2 = 0.324; p = .569). Conclusions In 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 ID NCT01535131

Source: The Cleft Palate-Craniofacial Journal

DOI: 10.1177/10556656261438891

Authors: Cuneyt M. Alper, Miriam S. Teixeira, Ellen M. Mandel, J. Douglas Swarts, Joseph E. Losee

Institutions: University of Pittsburgh, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Arnot Ogden Medical Center

Language: English

Topic: Cleft Lip and Palate Research

Subfield: Genetics

Field: Biochemistry, Genetics and Molecular Biology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $4,150