The objective of this study is to determine the most effective surgical procedure for correcting velopharyngeal insufficiency (VPI). Toward this end, the two most commonly performed procedures, sphincter pharyngoplasty and pharyngeal flap, will be prospectively compared in terms of perceptual speech results, airway physiology, complications (including obstructive sleep apnea), facial growth, and financial costs. Subjects with repaired cleft palate and residual VPI, identified by perceptual speech evaluation and confirmed by video nasopharyngoscopy, will be prospectively randomized between sphincter pharyngoplasty and pharyngeal flap for surgical management. All subjects will be between the ages of three and nine years at the time of surgery, and standardized surgical techniques will be used at four participating centers. Subjects will be evaluated preoperatively, perioperatively, and postoperatively for several indicators of outcome, including perceptual speech evaluation, video nasopharyngoscopy, airway physiology, lateral cephalometric radiographs (resting and phonating), and polysomnographic sleep studies. The estimated number of subjects will be 292, enrolled during a four year period. Minimum follow-up will be one year, necessitating a total project period of five years.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Research Project (R01)
Project #
5R01DE010426-06
Application #
2131335
Study Section
Special Emphasis Panel (SRC (25))
Project Start
1992-09-01
Project End
1998-08-31
Budget Start
1996-09-01
Budget End
1998-08-31
Support Year
6
Fiscal Year
1996
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Surgery
Type
Schools of Medicine
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
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Sloan, G M (2000) Posterior pharyngeal flap and sphincter pharyngoplasty: the state of the art. Cleft Palate Craniofac J 37:112-22
Sloan, G M; Wells, K C; Raffel, C et al. (1997) Surgical treatment of craniosynostosis: outcome analysis of 250 consecutive patients. Pediatrics 100:E2
Ward, S L; Marcus, C L (1996) Obstructive sleep apnea in infants and young children. J Clin Neurophysiol 13:198-207
Witt, P D; D'Antonio, L L; Zimmerman, G J et al. (1994) Sphincter pharyngoplasty: a preoperative and postoperative analysis of perceptual speech characteristics and endoscopic studies of velopharyngeal function. Plast Reconstr Surg 93:1154-68
Witt, P D; D'Antonio, L L (1993) Velopharyngeal insufficiency and secondary palatal management. A new look at an old problem. Clin Plast Surg 20:707-21