The incidence of cleft lip/palate is 1/750, making it one of the most common congenital malformations. The primary goal in surgically repairing the palatal cleft is to construct a competent velopharyngeal port for the development of normal speech. Failure to establish velopharyngeal competency results in speech characterized by hypernasality, loss of intraoral air pressure through the nose, and articulation disorders. The University of Florida, in collaboration with the University of Sao Paulo, Bauru, Brazil, is proposing a five-year continuation prospective randomized, controlled study to complete the assessment of velopharyngeal function for speech following palatoplasty (by the von Langenbeck procedure with intravelar velar plasty, and the Furlow double opposing z-plasty palatoplasty) for 352 subjects with complete unilateral cleft lip and palate. The von Langenbeck procedure has been selected as the time tested standard against which the Furlow procedure can be judged. The Furlow procedure has been reported to yield higher rates of velopharyngeal competency than identified in most other reported series, which also theoretically should result in less disturbance to mid-facial growth. Fewer patients than projected (explained in the text), were available for enrollment by the end of the initial study (9/99), and less than 50 were old enough for reliable assessment of their velopharyngeal competency for speech. Continuation of the study will allow enrollment of all 352 patients and the comparison of results between patients operated between 9-12 months of age and patients 15-18 months of age. Perceptual and instrumental measures of speech and velopharyngeal function will be obtained on all patients within the five year time frame of the proposed project. Facial growth analysis, although not a part of the proposed study, will continue until all patients reach maturity. The clinical caseload at the University of Sao Paulo currently exceeds 29,000 and over 1,500 new cases of cleft lip/palate are added yearly. This project represents a unique opportunity to obtain prospective data with a large number of subjects, controlling the variables which have traditionally plagued cleft palate studies. This study should definitively answer the question of which of the two surgical procedures is superior in constructing a velum capable of effecting velopharyngeal competency for the development of normal speech. In addition, this study may serve as a model for international prospective clinical trials, such as in Russia and Ukraine where treatment of cleft palate is centralized.
| Antonelli, Patrick J; Jorge, José C; Feniman, Mariza R et al. (2011) Otologic and audiologic outcomes with the Furlow and von Langenbeck with intravelar veloplasty palatoplasties in unilateral cleft lip and palate. Cleft Palate Craniofac J 48:412-8 |
| Williams, William N; Seagle, M Brent; Pegoraro-Krook, Maria Ines et al. (2011) Prospective clinical trial comparing outcome measures between Furlow and von Langenbeck Palatoplasties for UCLP. Ann Plast Surg 66:154-63 |
| Marques, Ilza L; Nackashi, John A; Borgo, Hilton C et al. (2009) Longitudinal study of growth of children with unilateral cleft-lip palate from birth to two years of age. Cleft Palate Craniofac J 46:603-9 |
