VELOPHARYNGEAL FUNCTION FOR SPEECH AFTER PALATAL SURGERY

腭手术后的腭咽功能

• 批准号: 2796462
• 负责人: WILLIAM N WILLIAMS
• 金额: $ 23.29万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-30 至 2000-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2796462
• 关键词: Brazil; age difference; audiometry; behavioral /social science research tag; child physical development; cleft lip; cleft palate; cleft palate prosthesis; cooperative study; craniofacial; human subject; infant human (0-1 year); longitudinal human study; postoperative complications; postoperative state; preoperative state; preschool child (1-5); psychological adaptation; socioeconomics; speech; statistics /biometry; surgery

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.

描述：这是应用程序的第二次修订 最初是为了回应 RFA 而提交的。 本申请是 佛罗里达大学颅面科合作研究 中心和圣保罗大学研究医院 巴西唇腭裂患者的康复。 如在 之前提交的内容是一项为期五年的前瞻性随机对照研究 建议进行研究临床试验（RCT）来比较腭咽功能 完全性单侧唇裂腭成形术的言语效果 腭，通过 von Langenbeck 手术进行 软腭成形术和Furlow 双对向z 形成形术腭成形术。 这 von Langenbeck 程序被认为是标准 将比较“相对较新的”Furlow 程序。 弗洛 据报道，该手术的腭咽癌发生率较高 能力，从而提高演讲成绩，也应该导致 对中面部生长的干扰较小。临床病例数 唇裂患者研究与康复医院 位于巴乌鲁的 Palate 每年新增患者 1,200 名。 这是 预计整个研究组的 608 名患者均可进入 在学习的头两年内。 2x2x2 因子设计是 描述涉及唇部修复类型（Spina 与 Milard）、年龄 手术（9-12 个月与 15-18 个月）和腭修复类型（von 兰根贝克与弗洛）。 固定长度、分块随机化 由外科医生分层的算法将用于分配 阶乘的八个单元格中的参与者均等 设计。将在 21 个月的时间内招募患者。 广泛的 数据库将根据术前评估和术后评估进行汇总 手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 佛罗里达州负责数据管理、编辑和统计分析。 除了 两种腭成形术的初步比较，申请人 计划评估手术年龄对术后的影响 腭咽言语能力、手术年龄对口咽功能的影响 发音错误的严重程度、腭手术类型的影响 发音错误的严重程度、手术年龄和类型的影响 腭手术对术后耳科和听力状态的影响， 家庭社会经济地位与腭咽部的关系 能力和表达能力、家庭关系 适应和术后言语结果以及手术的影响 手术技术和年龄对术后频率的影响 并发症。