Functional Outcomes of Cleft Lip Surgery. Part I: Study Design and

Objective: Children with a cleft of the upper lip exhibit obvious facial disfig-urement. Many require multiple lip surgeries for an optimal esthetic result. However, because the decision for lip revision is based on subjective clinical criteria, clinicians may disagree on whether these surgeries should be per-formed. To establish more reliable, functionally relevant outcome criteria for evaluation and treatment planning, a clinical trial currently is in progress. In this article, the design of the clinical trial is described and results of a study on subjective evaluations of facial form by surgeons for or against the need for lip revision surgery are presented. Design: Parallel, three-group, nonrandomized clinical trial and subjective evaluations/ratings of facial views by surgeons. Subjects: For the clinical trial, children with repaired cleft lip and palate scheduled for a secondary lip revision, children with repaired cleft lip and pal-ate judged not to need lip revision, and noncleft children. For the subjective evaluations, surgeons ’ facial ratings of 21 children with repaired cleft lip