Donor Site Morbidity and Buccinator Muscle Integrity After Buccinator Myomucosal Flap Surgery in Patients With Velopharyngeal Incompetence

NCT07853872 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-8-22MS
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate donor site morbidity and buccinator muscle integrity following the use of buccinator myomucosa flap in patients with velopharyngeal incompetence.

Conditions

Donor Site; Morbidity; Buccinator Muscle; Integrity; Buccinator Myomucosal Flap Surgery; Velopharyngeal Incompetence

Outcome Measures

Primary Outcomes (1)

• Buccinator muscle functional integrity

  Buccinator function will be assessed by the 10-second cheek puff test to retain air for 10 seconds. The examiner will record whether the participant completes the test and whether air leakage or facial asymmetry is observed.

  3 months after surgery

Study Arms (1)

Buccinator Myomucosal Flap Group

Patients with velopharyngeal incompetence undergoing palatal lengthening using bilateral posteriorly based buccinator myomucosal flaps.

Procedure: Bilateral posteriorly based buccinator myomucosal flap surgery

Interventions

Bilateral posteriorly based buccinator myomucosal flap surgery PROCEDURE

Palatal lengthening will be performed using bilateral posteriorly based buccinator myomucosal flaps in patients with velopharyngeal incompetence.

Buccinator Myomucosal Flap Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a prospective comparative and retrospective study designed to evaluate the donor site morbidity and buccinator muscle integrity after buccinator myomucosal flap in patients with velopharyngeal incompetence

You may qualify if:

• Patients diagnosed with velopharyngeal incompetence undergoing palatal lengthening using bilateral posteriorly based buccinator myomucosal flaps.
• Non-syndromic patients.

You may not qualify if:

• Syndromic cleft patients with associated neuromuscular disorders.
• History of previous cheek surgery affecting the buccinator muscle.
• Patients who declined participation in the study.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82511, Egypt

Location

MeSH Terms

Conditions

Velopharyngeal Insufficiency

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Diseases; Stomatognathic System Abnormalities; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Abdelrahman S Ahmad, MBBCH

CONTACT

00201013858729; abdelrahamn.saleh@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Plastic Surgery, Faculty of Medicine, Sohag University, Egypt

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)