Clinical Trial: Assessing the Results of Lip Surgery in Patients With Cleft Lip and Palate
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Functional Outcomes of Cleft Lip and Lip Revision Surgery
Brief 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 Summary:
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
- In a prospective non-randomized controlled clinical trial, evaluate the efficacy of lip revision surgery by
Sponsor: University of North Carolina, Chapel Hill
Current Primary Outcome: Facial movement/animation [ Time Frame: 6 ]
Original Primary Outcome: Facial animation
Current Secondary Outcome:
- Lip Force [ Time Frame: 6 ]
- EMG [ Time Frame: 6 ]
- Lip sensation [ Time Frame: 6 ]
Original Secondary Outcome:
Information By: University of North Carolina, Chapel Hill
Dates:
Date Received: October 8, 2003
Date Started: August 2001
Date Completion:
Last Updated: July 2, 2013
Last Verified: July 2013
