Journal
CLEFT PALATE-CRANIOFACIAL JOURNAL
Volume 48, Issue 4, Pages 412-418Publisher
ALLIANCE COMMUNICATIONS GROUP DIVISION ALLEN PRESS
DOI: 10.1597/10-009
Keywords
cleft palate; clinical trial; ear; hearing
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Funding
- NIDCR [R01 DE10437 01AZ]
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Objective: Cleft palate increases the risk of chronic middle ear disease and hearing loss. The goal of this report was to determine which of two palate surgeries and which timing of palate surgery were associated with better otologic and audiologic outcomes in children with unilateral cleft lip and palate at 5 to 6 years of age. Design: Subjects were randomly assigned to the von Langenbeck with intravelar veloplasty or Furlow palate repair, to palate surgery at 9 to 12 months or 15 to 18 months of age, and to the Spina or Millard lip repair. Setting: Centralized, tertiary care craniofacial treatment center. Patients: A total of 673 infants with unilateral cleft lip and palate. Interventions: Palate and lip were repaired using established techniques. Serial otoscopic and audiometric evaluations were performed. Main Outcome Measures: Hearing and otoscopic findings at 5 to 6 years old. Results: There were 370 children available for analysis. Hearing and need for tympanostomy tube placement did not differ by palatoplasty, age at palatoplasty, cheiloplasty, or surgeon. Risk of developing cholesteatoma or perforation was higher with Millard cheiloplasty (odds ratio = 5.1, 95% confidence interval = 1.44 to 18.11, p = .012). Type and age at palatoplasty were not significantly associated with either the rate of developing these sequelae or the rate of achieving bilaterally normal hearing and ear examinations. Conclusions: Type of palatoplasty did not influence otologic and audiologic outcomes in 5- to 6-year-olds with unilateral cleft lip and palate. The potential influence of lip repair on otologic outcomes warrants further investigation.
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