Functional Outcomes of Cleft Lip Surgery

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Primary surgical repair of a cleft lip has significant potential for scarring and disfigurement of the upper lip and nose that requires further correction. Patients, their parents, and the operating surgeons must decide whether the benefits of a secondary lip revision following primary correction of a cleft lip outweigh the risks. Until recently, quantitative data on the benefits of revision surgery have been lacking, and the clinical recommendations for or against revision surgery have necessarily been based on subjective and, therefore, variable evaluations. In the initial grant period, a non-randomized clinical trial was conducted that resulted in significant progress towards the development and characterization of objective quantitative outcomes of revision surgery in patients with cleft lip and palate. The database so established is now the only one in the world that has extensive objective measures of three-dimensional facial soft-tissue movement and morphology, lip force, lip sensation, and sensory-integrative function. The investigations proposed here represent an expansion of this research. Thus, the goals of this continuing project are as follows. 1) To determine how surgeons might use the newly-developed objective measures of lip function in the decision-making process for or against lip revision surgery. 2) To establish "parameters of care" criteria for secondary lip revision treatment based on standardized, systematic subjective evaluations, and objective measurements. 3) To investigate the long- term functional outcomes of lip revision surgery. This information will be obtained by continuing the present clinical trial and by enrolling an additional cohort of 30 new patients who will receive lip revision surgery. The central hypothesis continues to be that "although contemporary lip revision surgery may improve lip form at rest, function may be further impaired". This research will enable surgeons to address the following outcomes, and in doing so provide improved patient care: 1) measure the specific functional deficits that are present post-primary lip repair; 2) assess the effectiveness of current primary and secondary lip operations; 3) assess the long-term effects of lip repair on the maintenance of the circumoral milieu; 4) determine whether secondary lip surgery results in significant improvement in lip form and function; and 5) determine whether additional surgery is really warranted. In the future, these evaluations can be used to determine the outcomes of different surgical techniques forlip- revision surgery.