Furlow With Buccinator and Velopharyngeal Function

NCT ID: NCT06229587

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-03-01

Brief Summary

Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done. Middle ear function was assessed by clinical otoscopic examination and by tympanometry to detect the presence or absence of middle ear effusion and the need for tympanostomy tubes. Speech outcomes were assessed using perceptual speech assessment for the degree of hypernasality, compensatory misarticulation and speech intelligibility. Nasopharyngoscopic examination of the patients was done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap

Conditions

Cleft Palate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

furlow with buccinator arm

Group Type: EXPERIMENTAL

furlow with buccinator flap

Intervention Type: PROCEDURE

Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done

Interventions

furlow with buccinator flap

Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• - Age 3 to 7 years
• 1ry cleft repair by furrolow with buccal myomucosal flap
• Non syndromic previously treated children
• Cleft repaired by the same surgeon

Exclusion Criteria

• - Syndromic patient
• Cleft palate repair by any technique except furlow with buccal myomucosal flap

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mohsen

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hearing Institution

Giza, , Egypt

Countries

Egypt

Other Identifiers

13

Identifier Type: -

Identifier Source: org_study_id