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.Address correspondence to: Dr. Carroll-Ann Trotman, CB #7450, 275 Brauer Hall, Chapel Hill, NC 27599-7450. carrollann_trotman@dentistry.unc.edu.. NIH Public Access Author ManuscriptCleft Palate Craniofac J. Author manuscript; available in PMC 2013 May 07. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author ManuscriptAnalysis-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. Keywords clinical trial; functional outcomes; lip revision surgeryFor a child with a cleft of the lip with or without a cleft palate, the decision to surgically revise the lip is based on a subjective evaluation of lip form and function that is made by the surgeon either independently or in conjunction with the patient and parents (Marsh, 1990). Subjective evaluation defines the current standard of care for patients who are candidates for lip revision; however, recent research has demonstrated many limitations with the use of subjective assessments. Of particular concern are the lack of agreement among clinicians (Asher-McDade et al., 1991;Tobiason et al., 1991;Ritter et al., 2002;Morrant and Shaw, 1996) and a tendency for the assessment of lip form to confound the assessment of lip function (Ritter et al., 2002). For example, when the severity of the deformity of static faces (i.e., faces at rest) was rated subjectively by clinicians, interexaminer agreement ranged from low (Asher-McDade et al., 1991) to good (Tobiason et al., 1991;Ritter et al., 2002), whi...

Effects of Lip Revision Surgery in Cleft Lip/Palate Patients

“…Children can have multiple surgeries of this type that generally are performed between 5 and 8 yrs of age, or later during adolescence. The decision for surgery is based on the surgeon's subjective evaluation of the lip at rest and during function, and clinicians recognize that more objective evaluation methods would be highly beneficial for the decision-making process (Brattstrom et al , 2005; Trotman et al , 2007a). …”

Functional Outcomes of Cleft Lip Surgery. Part II: Quantification of Nasolabial Movement

“…function have been made by operating surgeons (Trotman et al, 2007). Clearly, for some patients, the initial, primary surgical repair of the cleft lip and nose has significant potential for scarring and disfigurement that requires further surgical correction.…”

“…As a first step toward objectively quantifying function in a large group of subjects, a clinical trial to evaluate the functional outcomes of cleft lip surgery was instituted. The details of the trial are provided in a companion article (Trotman et al, 2007). One aim of this clinical trial was to explore the nasolabial movement in participants with repaired cleft lip and palate.…”

Effects of Lip Revision Surgery on Long-Term Orosensory Function in Patients with Cleft Lip/Palate

“…The lip revision surgery was performed at the recommendation of the surgeon after consultation with the patient and parents. The surgical technique has been described previously (Trotman et al, 2007). …”