Assessing the Results of Lip Surgery in Patients With Cleft Lip and Palate
Condition: Cleft Lip; Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Observational

Summary: 
      The purpose of this study is to determine whether secondary (revision) surgery to the lip in
      patients with cleft lip and palate is effective in improving lip function and appearance.
    

Detailed description: 
      Children born with clefting of the upper lip exhibit obvious disfigurement of the upper lip
      and nose. As illustrated below, primary lip surgery of the infant dramatically improves the
      severe deformity of the perioral and nasal region. It is widely recognized, however, that
      most patients require additional lip surgeries for an optimum esthetic result. Clinicians
      often disagree as to when this end point is reached since the decision for additional lip
      revision is based on subjective clinical assessments.

      Facial morphology during function has a major impact on how a person is perceived in society
      and is known to be an important component of the esthetic outcome for cleft patients, but it
      has been particularly difficult to incorporate measures of lip function into the
      decision-making process. It is likely that the different surgical procedures for both primary
      lip closure and secondary lip revision could be improved if the effects of alternative
      surgical techniques on function were better understood. The subjects for this project consist
      of two cleft lip and palate patient groups treated at the University of North Carolina (UNC)
      Craniofacial Center: one cleft group will be patients who are candidates for additional lip
      revision surgery; the other cleft group will be patients who have been judged not to need lip
      revision; and a matched non-cleft group who present for routine dental care at UNC School of
      Dentistry. The goals of this project are to objectively measure and quantify functional
      facial impairment in cleft patients, and to establish more reliable, functionally relevant
      outcome criteria for treatment planning and evaluation of these individuals. Our specific
      aims, therefore, are to

        1. In a prospective non-randomized controlled clinical trial, evaluate the efficacy of lip
           revision surgery by a) Examining longitudinal changes in function after lip revision,
           and b) Examining whether the change in function after lip revision differs from the
           change that would be observed due to maturation only in the matched non-cleft 'normal'
           group, and the change in the cleft but non-lip revised group.

        2. a) Estimate the effect of cleft lip and palate on function after primary lip and palate
           repair but prior to lip revision surgery by comparing those patients scheduled to
           receive a lip revision with those who are judged not to need a lip revision, and b)
           Estimate the impairment in function in cleft lip and palate patients without lip
           revision relative to matched non-cleft subjects.

        3. Compare the assessments of dynamic lip function provided by objective measures with
           subjective clinical judgments/ratings of craniofacial plastic surgeons who perform lip
           revision surgery, and evaluate the potential of the new methods for clinical
           application.

        4. Evaluate whether objective information when added to the clinician's subjective
           evaluation of a patient alters the surgical treatment plan or the goals of treatment
           when subjective and objective information are incorporated in the decision-making and
           treatment planning process. This specific aim will be useful in adapting and assessing
           the potential of the new objective methods for application in a clinical setting.

        5. To establish 'parameters of care' criteria for secondary lip revision treatment
           decision-making based on standardized, systematic subjective evaluation, and an
           objective measurement of movement capacity during function of the upper lip.

        6. Assess the long-term effects of maturation on function following lip revision by
           continuing data-collection beyond the one-year post-revision on patients recruited
           during the period of the initial grant and long-term follow-up (18 and 30 months) on
           newly recruited lip revision patients, and in so doing, evaluate the efficacy of cleft
           lip revision surgery.

      To address these aims, we have identified a group of highly qualified individuals with widely
      recognized expertise in the application of the proposed methodologies, and a panel of
      surgeons experienced in cleft care for clinical evaluation of outcomes. This expertise, the
      availability of an appropriate patient resource, and the home institution's 40-year history
      of strong commitment to the care of these patients and craniofacial research, all favor
      success in meeting the goals of the project.
    

Intervention name(s): Lip revision surgery
Intervention type(s): Procedure
Intervention description(s): Full or partial muscle thickness lip revision surgery.
Other intervention name(s): Primary lip repair; Secondary lip repair
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited and screened mainly in the UNC Craniofacial Center, the Graduate
        Orthodontic Clinic, the Pediatric Dentistry Clinic, and the Orthodontic Faculty Practice of
        the University of North Carolina.
      
Keywords: Facial form; Facial animation; Lip muscle reconstruction; Lip form; Lip function