The Possible Effect of Modified Restoration of Tensor Veli Palatini on Audiological and Otological Outcome in Cleft Palate Repair.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Hearing level
研究概览
简要总结
to study the benefical audiological and/or otological effect by mordified restoration of tensor veli palatini in cleft palate repair compared to traditional Langenbeck's repair and merely levator veli palatini restoration.
详细描述
71 patients with cleft palate received surgery were divided into 3 groups. Group 1: patients who received Langenbeck surgery without specific restoration of levator veli palatini or tensor veli palatini. Group 2: patients who received palate surgery with special levator veli palatini restoration. Group 3: patients who received palate surgery with modified tensor veli palatini restoration. The conductive auditory brainstem response and 226 Hz tympanometry were used to test the audiological and otological status of the three groups. Preoperative and postoperative results were compared intragroup and intergroup.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of cleft palate.
- •Primary palate repair.
排除标准
- •Severe general disease
- •Confirmed hereditary hearing loss or neuropathic hearing loss.
- •Received any kind of audiological or otological therapy before.
- •Patients and/or his/her don't want to continue the clinical trial.
结局指标
主要结局
Hearing level
时间窗: 0 to 3 months before surgery
Auditory brainstem response was tested in all three groups before surgery. The air conductive hearing threshold was used to assess the hearing level.
The otological status of middle ear
时间窗: 0 to 3 months before surgery
226 tympanometry was tested in all three groups before surgery. The results of 226 Hz tympanometry were classified based on Liden/Jerger classification. Four classes of tympanometry results were included.
次要结局
未报告次要终点
研究者
Lian Zhou
Prof.
Peking Union Medical College Hospital