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临床试验/NCT05196555
NCT05196555已完成不适用

Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
change in nasal airflow

研究概览

简要总结

Cleft palate repair is the most important component of cleft surgery, not only in that it determines the outcome as far as speech and communication are concerned, but also in that it potentially has the greatest impact on maxillary growth and the dental arch relationship. Sommerlad technique has been described as a more physiological approach, aiming to restore the anatomy of the velum. This technique, often described as radical intravelar veloplasty, has the following distinctive components: a radical retroposition of velar musculature (m. levator veli palatini, m. palatoglossus, and m. palatopharyngeus), combined with minimal dissection of the hard palate, a tensor tenotomy, and the repair of the m. levator sling

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
9 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with isolated cleft palate age from 9 months to 18 years.
  • Patients with submucous cleft.
  • Velopharyngeal incompetence (VPI) for palatal re-repair.

排除标准

  • Medically unfit patients.
  • Syndromic patients with cleft lip and palate.
  • Patients with cleft palate associated with multiple congenital anomalies.
  • Patients with neurological disorders.

结局指标

主要结局

change in nasal airflow

时间窗: Baseline, immediately after procedure

Using Nasometer II model 6450 to assess the ratio of oral airflow to nasal airflow.

change in soft palate elevation

时间窗: Baseline, immediately after procedure

Observing the range of motion of soft palate using videofluoroscopy

change in tongue motion assessment

时间窗: Baseline, immediately after procedure

Observing the range of tongue motion using videofluoroscopy

change in lips motion assessment

时间窗: Baseline, immediately after procedure

Observing the range of lips motion using videofluoroscopy

次要结局

未报告次要终点

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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