SPEECH AND FACIAL DEVELOPMENT AFTER PALATAL SURGERY

描述：这是一个应用程序的第二次修订， 最初提交是为了响应RFA。 本申请 佛罗里达大学颅面医学中心 该中心和圣保罗大学研究和 巴西唇腭裂患者的康复。 如在 之前提交的一项为期5年的前瞻性随机对照研究 研究临床试验（RCT）拟比较咽喉功能 单侧完全性唇裂腭裂修复术的语音效果， 腭，采用von Langenbeck手术和intravelar 软腭成形术和Furlow双反向Z形成形术腭成形术。 的 von Langenbeck程序被认为是标准， 将比较“相对较新的”Furlow程序。 关于Furlow 据报道，该手术的咽部狭窄发生率更高， 能力，从而提高语音效果，也应该导致 减少对面部中部生长的干扰。诊所的工作量 唇裂患者研究和康复医院 Palate位于Bauru，每年有1，200名新患者。 是 预计整个研究组的608名患者可以进入 在研究的头两年里。 2x2 x2析因设计是 描述涉及唇修复类型（Spina与Milard），年龄 手术（9-12个月与15-18个月）和腭修复类型（von Langenbeck vs. Furlow）。 固定长度、区组随机化 将使用由外科医生分层的算法分配 在阶乘的八个单元格中， 将在21个月的时间内招募患者。 一个广泛 数据库将从术前评估和术后评估中收集， 术后每六个月安排一次手术访视。 研究数据 将以电子方式传输到大学的设施 佛罗里达进行数据管理、编辑和统计分析。 除了 两种腭裂手术的主要比较，申请人 计划评估手术时年龄对术后 手术时年龄对语言能力的影响 发音错误的严重程度，腭手术类型对 发音错误的严重程度、手术时年龄的影响和 腭部手术对术后耳科和听力状况的影响， 家庭社会经济地位与咽喉炎的关系 能力和发音能力，家庭关系 适应和术后语音结果以及手术的影响 手术时的技术和年龄对术后频率的影响 并发症

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.