Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure

Not Applicable

Completed

• Conditions: Velopharyngeal Insufficiency
• Interventions: Procedure: myomucosal resection and direct closure; Procedure: superiorly based flap

• Registration Number: NCT06343623
• Lead Sponsor: Minia University

Brief Summary

Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall

Detailed Description

Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall

Study Timeline

• Study Start: 2018-10-12
• Primary Completion: 2022-10-16
• Study Completion: 2022-10-16
• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• • Patients have velopharyngeal insufficiency.
• Age range 4-10 years

Exclusion Criteria

• • Syndromic patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
myomucosal resection and direct closure	myomucosal resection and direct closure	myomucosal resection and direct closure
superiorly based flap	superiorly based flap	superiorly bases pharyngeal flap

Primary Outcome Measures

Name	Time	Method
Improvement in the speech outcome	4 years	Improvement in the speech outcome using auditory perception assessment and videonasoendoscopy

Secondary Outcome Measures

Name	Time	Method
obstructive sleep apnea	3 years	obstructive sleep apnea using respiratory function test

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Minya, Egypt