Functional Outcomes of Cleft Lip Surgery

University Of North Carolina Chapel Hill, Chapel Hill NC

Investigators

Linked publications & trials

Abstract

DESCRIPTION: (from the abstract) The prevalence of cleft lip and palate in the United States is approximately 1 in 1000 live births (range of 0.7 to 1.3). Children born with this congenital birth defect exhibit obvious disfigurement of the upper lip and nose. Although the initial surgery to the cleft lip achieves adequate closure of the defect, it is widely recognized that additional (revision) surgeries are needed to achieve optimal lip form and function. The decision to perform these additional surgeries, however, is based largely on subjective clinical assessments made by the operating surgeon. Given that facial form during function has a major impact on how a person is perceived in society, it is important that objective measures of function be incorporated into the decision making process. This is currently not the case. The goals of this project are the following: (1) to evaluate the gain/loss in esthetics and impairment both at rest and during function of lip revision surgery; (2) to measure and quantify functional facial impairment in cleft patients; (3) to compare objective measures of function to subjective evaluations made by experienced plastic surgeons; and (4) to assess the usefulness of functionally-relevant outcome for patient evaluation. The subjects for this project consist of two groups of cleft lip and palate patients treated at the University of North Carolina Craniofacial Center: one group will be patients who have been judged to need lip revision surgery; the second group will be matched patients who have been judged not to need lip revision; an additional group will be matched non-cleft patients who present for routine dental care at the UNC School of Dentistry. The global hypothesis to be tested is that although contemporary lip revision surgery may improve lip form at rest, function may be further impaired. This hypothesis will be tested by using new methods that can systematically quantify motor function, tissue biomechanics, and sensory functions in cleft and non-cleft subjects. The efficacy of lip revision surgery will be evaluated in a prospective non-randomized controlled clinical trial. By comparing the objective assessments of dynamic function with the clinical judgements of craniofacial plastic surgeons, who perform lip revision surgery, the investigators will evaluate the potential of the new methods for clinical application. To accomplish the goals of this project in an effective and cost-efficient way, the investigators have employed subcontracts with both the University of Kansas and the University of Michigan.