Functional outcomes of cleft lip surgery. Part I: Study design and surgeon ratings of lip disability and need for lip revision.

OBJECTIVE Children with a cleft of the upper lip exhibit obvious facial disfigurement. 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 performed. 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 palate who did not have lip revision, and noncleft children. For the subjective evaluations, surgeons' facial ratings of 21 children with repaired cleft lip. ANALYSIS Descriptive and Kappa statistics assessing the concordance of surgeons' ratings of (a) repeated facial views and (b) a recommendation of revision on viewing the prerevision and postrevision views. RESULTS The surgeons' consistency in rating repeated views was moderate to excellent; however, agreement among the surgeons when rating individual participants was low to moderate. CONCLUSIONS The findings suggest that the agreement among surgeons was poor and support the need for more objective measures to assess the need for revision surgery.