VELOPHARYNGEAL FUNCTION FOR SPEECH AFTER PALATAL SURGERY

描述：这是申请的第二次修订

DESCRIPTION: This is the second revision of an application which was originally submitted in response to a RFA. The present application is for a collaborative study between the University of Florida Craniofacial Center and the University of Sao Paulo, Hospital for Research and Rehabilitation of patients with Cleft Lip and Palate, in Brazil. As in the previous submission, a five year, prospective randomized controlled study clinical trial (RCT) is proposed to compare velopharyngeal function for speech outcomes of palatoplasty for complete unilateral cleft lip and palate, performed with the von Langenbeck procedure with intravelar velar plasty and the Furlow double opposing z-plasty palatoplasty. The von Langenbeck procedure is considered to be the standard against which the "relatively new" Furlow procedure will be compared. The Furlow procedure has been reported to have a higher rate of velopharyngeal competency and hence improved speech results and also should result in less disturbance to mid-facial growth. The clinical caseload at the Hospital for Research and Rehabilitation of patients with Cleft Lip and Palate, located in Bauru, is 1,200 new patients per year. It is anticipated that the entire study group of 608 patients can be entered within the first two years of the study. A 2x2x2 factorial design is described involving type of lip repair (Spina versus Milard), age at surgery (9-12 months versus 15-18 months) and type of palate repair (von Langenbeck versus Furlow). A fixed length, blocked randomization algorithm, which will be stratified by surgeon, will be used to allocate participants equally among the eight cells of the factorial design.Patients will be recruited over a 21 month period. An extensive data base will be assembled from pre-operative assessments and post- operative visits scheduled every six months post-surgery. Study data will be transmitted electronically to facilities at the University of Florida for data management, editing and statistical analysis. Besides the primary comparison of the two palatoplasty procedures, the applicant plans to assess the impact of age at surgery on post-operative velopharyngeal competency for speech, impact of age at surgery on the severity of articulatory errors, impact of type of palatal surgery on severity of articulatory errors, impact of age at surgery and type of palatal surgery on post-operative otologic and audiologic status, relationship between family socioeconomic status and velopharyngeal competency and articulatory proficiency, relationship between family adaption and post-operative speech outcome and impact of surgical technique and age at surgery on the frequency of post-operative complications.