Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair

Cleft Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366674
• Other study ID #: S-K1145
• Status: Completed
• Phase: N/A
• Start date: January 1, 2013
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 30, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 60 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Procedure:
• cleft palate repair
restoration of tensor veli palatini for the purpose of the muscle function recovery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after surgery
Primary	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.	3 months after surgery
Primary	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.	0 to 3 months before surgery
Primary	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.	0 to 3 months before surgery