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临床试验/NCT04366674
NCT04366674已完成不适用

The Possible Effect of Modified Restoration of Tensor Veli Palatini on Audiological and Otological Outcome in Cleft Palate Repair.

Peking Union Medical College Hospital0 个研究点目标入组 71 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

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.

研究组 & 干预措施

restoration of levator veli palatini

Active Comparator

The incision was made similar to Langerbeck's repair. During disection, the levator veli palatini was identified after the elevation of flap. The levator veli palatini was separate from the oral and nasal mucosa. During closing, the anterior end of levator veli palatini was rotated towards the midline and the two muscle bundle from the two sides were sutured in the midline. In this process, the tensor veli palatini was not intentionally identified or dissected.

干预措施: cleft palate repair (Procedure)

Langerbeck's repair

Active Comparator

Langerbeck's repair of cleft palate,without specific restoration of levator veli palatini or tensor veli palatini. Incisions along the margins of the cleft at the junction of oral and nasal mucosa. Lateral relaxing incisions were performed and the mucoperiosteal flap of hard palate were elevated on both sides except the ones with only soft palate cleft. The anterior end of the mucoperiosteal flap may be cut off for the purpose of tension relieving and would be resutured to the anterior area during closing. In the soft palate, the division was made between the oral mucous layer and the palatal musculature layer. Hamulus were broken for closing the cleft without tension. Closing was done by two seperated layers, one layer of nasal mucosa-palatal muscle, and one layer of oral mucosa.

干预措施: cleft palate repair (Procedure)

mordified restoration of tensor veli palatini

Experimental

Incision was made similar to Langerbeck's repair. During disection, the tensor veli palatini was identified after flap elevation. Its tendinous fibers was released from but still connected to the pterygoid process without breaking the hamulus or cutting off the tendinous fibers. If the tension is too strong during suturing, the tensor tendon could be partly dissected laterally meanwhile be kept continuity medially so that the tensor veli palatini could be rotated more medially. The levator veli palatini, tensor veli palatini, together with the palatine aponeurosis and the nasal mucosa from two sides were sutured in the middle line. The tensor veli palatini may not be jointed to the contralateral one directly.

干预措施: cleft palate repair (Procedure)

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.

Hearing level

时间窗: 3 months after surgery

Auditory brainstem response was tested in all three groups after surgery. The air conductive hearing threshold was used to assess the hearing level.

The otological status of middle ear

时间窗: 3 months after surgery

226 tympanometry was tested in all three groups after 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

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

Lian Zhou

Prof.

Peking Union Medical College Hospital

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