Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair

Peking Union Medical College Hospital71 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cleft Palate

Interventions

cleft palate repairPROCEDURE

restoration of tensor veli palatini for the purpose of the muscle function recovery.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 60 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of cleft palate. * Primary palate repair. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Hearing level

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

Time frame: 3 months after surgery

The otological status of middle ear

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.

Time frame: 3 months after surgery

Hearing level

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

Time frame: 0 to 3 months before surgery

The otological status of middle ear

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.

Time frame: 0 to 3 months before surgery

Data from ClinicalTrials.gov

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