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临床试验/NCT05626933
NCT05626933招募中不适用

Anatomical Restoration Cleft Palate Technique (ARC) for Secondary Velopharyngeal Incompetence Post Cleft Palate Repair

Fayoum University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
grade of velopharyngeal closure during speech

研究概览

简要总结

Nasopharyngoscopic examination of the 20 patients with secondary VPI following 2 flap palatoplasty will be 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 and after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty

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
5 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 5-6 years old children with previous treated complete cleft palate with 2 flap palatoplasty technique, nonsyndromic.
  • lip and palate repair performed by one craniofacial surgeon

排除标准

  • Patients with syndromic cleft lip.
  • Bilateral cleft lip
  • Patient older younger 5 years.
  • Associated Cardiac anomalies.
  • Any systemic condition

结局指标

主要结局

grade of velopharyngeal closure during speech

时间窗: immediate postoperative

Nasopharyngoscopic examination of the patients with secondary velopharyngeal insufficiency ( VPI) following two flap palatoplasty cleft palate repairs will be done for assessment of velopharyngeal closure grade during speech after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty

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

principal investigator

Fayoum University

研究点 (1)

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