MULTICENTER TRIAL OF PHARYNGOPLASTY AND PHARYNGEAL FLAP

咽成形术和咽瓣的多中心试验

• 批准号: 2131334
• 负责人: GERALD M SLOAN
• 金额: $ 21.19万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-01 至 1997-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2131334
• 关键词: audiometry; child (0-11); health care cost /financing; human subject; human therapy evaluation; longitudinal human study; nasopharynx; oral pharyngeal surgery; postoperative complications; radiography; respiratory airflow measurement; respiratory airway clearance; respiratory airway pressure; respiratory airway volume; respiratory center dysfunction; speech; statistics /biometry; videotape /videodisc

The objective of this study is to determine the most effective surgical procedure for correcting velopharyngeal insufficiency (VPI). Toward this end, the two most commonly performed procedures, sphincter pharyngoplasty and pharyngeal flap, will be prospectively compared in terms of perceptual speech results, airway physiology, complications (including obstructive sleep apnea), facial growth, and financial costs. Subjects with repaired cleft palate and residual VPI, identified by perceptual speech evaluation and confirmed by video nasopharyngoscopy, will be prospectively randomized between sphincter pharyngoplasty and pharyngeal flap for surgical management. All subjects will be between the ages of three and nine years at the time of surgery, and standardized surgical techniques will be used at four participating centers. Subjects will be evaluated preoperatively, perioperatively, and postoperatively for several indicators of outcome, including perceptual speech evaluation, video nasopharyngoscopy, airway physiology, lateral cephalometric radiographs (resting and phonating), and polysomnographic sleep studies. The estimated number of subjects will be 292, enrolled during a four year period. Minimum follow-up will be one year, necessitating a total project period of five years.

这项研究的目的是确定最有效的手术 纠正尾咽功能不全（VPI）的程序。 走向 这是两个最常见的程序，括约肌 咽部成形术和咽部皮瓣将被前瞻性地比较 感知言语结果，气道生理学，并发症的术语 （包括阻塞性睡眠呼吸暂停），面部增长和财务成本。 具有修复裂口和残留VPI的受试者，由 感知语音评估，并通过视频鼻咽镜检查确认 将在括约肌咽部成形术和 用于手术管理的咽瓣。 所有科目都将在 手术时的三岁和九岁的年龄，以及 标准化的手术技术将在四个参与 中心。 受试者将在术前，围手术期评估， 术后有几个结果指标，包括 感知语音评估，视频鼻腔检查，气道 生理学，侧向射线照相仪（静止和发音）， 和多个学术睡眠研究。 估计的受试者数量 将为292，在四年内招募。 最低随访 为一年，需要总项目期限为五年。