VELOPHARYNGEAL FUNCTION FOR SPEECH AFTER PALATAL SURGERY

描述：这是应用程序的第二个修订版 最初是在回应RFA时提交的。本申请是 佛罗里达大学颅面外科的一项合作研究 中心和圣保罗大学研究与发展医院 巴西唇腭裂患者的康复。如中所示 前一次提交，为期五年，前瞻性随机对照 研究临床试验(RCT)被建议用于比较腭咽闭合功能 对于单侧完全性唇裂的腭裂患者的语音效果 采用Von Langenbeck手术和InTraar进行腭裂手术 腭裂成形术和Fllow双反Z形腭裂成形术。这个 冯·朗根贝克手术被认为是 我们将比较“相对较新”的弗洛手术。《溪流》 据报道，该手术有较高的腭咽闭合发生率。 能力，因此提高了演讲结果，也应该导致 减少对面部中部生长的干扰。医院的临床病例数量 唇裂患者研究与康复医院 位于宝鲁的Palate每年有1200名新患者。它是 预计608名患者可以进入整个研究小组 在研究的头两年内。2x2x2析因设计为 描述涉及唇部修复的类型(脊柱与Milard)，年龄为 手术(9-12个月对15-18个月)和腭部修复类型(von 朗根贝克对弗洛)。固定长度的分组随机化 将由外科医生分层的算法将用于分配 参与者在阶乘的八个单元格中均等 设计。患者将在21个月的时间内招募。广泛的 数据库将由术前评估和术后评估汇编而成 术后每六个月安排一次手术探视。研究数据 将以电子方式传输到加州大学的设施 佛罗里达州用于数据管理、编辑和统计分析。此外 两种腭裂成形术的初步比较 计划评估手术年龄对手术后的影响 术中年龄对腭咽闭合功能的影响 关节错误的严重程度，腭部手术类型对 关节畸形的严重程度、手术年龄和类型的影响 腭部手术对术后耳科和听力学状况的影响 家庭社会经济地位与腭咽闭合的关系 能力和发音能力，家庭之间的关系 手术适应症与术后语音转归及影响 手术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.