Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure

Velopharyngeal Insufficiency Clinical Trial

Official title:

Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06343623
• Other study ID #: fac.med.2018.15
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: October 16, 2022

Study information

• Verified date: March 2024
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 16, 2022
• Est. primary completion date: October 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• - Patients have velopharyngeal insufficiency.

• Age range 4-10 years

Exclusion Criteria:

• - Syndromic patients.

Related Conditions & MeSH terms

• Velopharyngeal Insufficiency

Intervention

Procedure:
• myomucosal resection and direct closure
myomucosal resection and direct closure
• superiorly based flap
superiorly based pharyngeal flap

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in the speech outcome	Improvement in the speech outcome using auditory perception assessment and videonasoendoscopy	4 years
Secondary	obstructive sleep apnea	obstructive sleep apnea using respiratory function test	3 years