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临床试验/NCT06229587
NCT06229587已完成不适用

Speech and Middle Ear Outcomes Following Primary Cleft Palate Repair by Furlow Z-plasty Technique With a Buccinator Myomucosal Flap

Fayoum University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
speech assessement

研究概览

简要总结

Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done. Middle ear function was assessed by clinical otoscopic examination and by tympanometry to detect the presence or absence of middle ear effusion and the need for tympanostomy tubes. Speech outcomes were assessed using perceptual speech assessment for the degree of hypernasality, compensatory misarticulation and speech intelligibility. Nasopharyngoscopic examination of the patients was done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • - Age 3 to 7 years
  • 1ry cleft repair by furrolow with buccal myomucosal flap
  • Non syndromic previously treated children
  • Cleft repaired by the same surgeon

排除标准

  • - Syndromic patient
  • Cleft palate repair by any technique except furlow with buccal myomucosal flap

结局指标

主要结局

speech assessement

时间窗: 3years

Nasopharyngoscopic examination of the cleft patients after repair with Furlow with buccinator flap allowing assessment of the grade of velopharyngeal closure during speech

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaimaa Mohsen

principle investigator

Fayoum University

研究点 (1)

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