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

Abstract

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.

Figures

FIGURE 1

Schematic of the testing times for the three participant groups. The revision participants are tested twice before revision (−3 and 0 months) and twice after revision (3 and 12 months). The nonrevision and noncleft participants are tested at similar time intervals (0, 3, 6, and 15 months).

FIGURE 2

Power curves for a one-way analysis of variance with three groups and single one-way between-means contrast (comparing two of the three groups assuming the overall test is significant) generated by varying the effect size or sample size.

FIGURE 3

Example of the screen for viewing participant photographs and videotapes. Selecting a still image will enlarge it. Selecting video will play the different animations with frontal and profile images combined.