Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty
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
- 否
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
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University
