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Clinical Trials/NCT06477679
NCT06477679
Not yet recruiting
Not Applicable

Velopharyngeal Insufficiency Evaluation Post Cleft Palate Repair. Furlow With Buccinator Myomucosal Flap Versus Two Flap Palatoplasty

Sohag University1 site in 1 country50 target enrollmentJune 2024
ConditionsCleft Palate

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cleft Palate
Sponsor
Sohag University
Enrollment
50
Locations
1
Primary Endpoint
Velopharyngeal Insufficiency Evaluation
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

Cleft palate is one of the most common congenital abnormalities of the orofacial region throughout the world. This condition can cause facial deformity, feeding problems, frequent middle ear infections, dental defects, speech abnormalities and emotional problems . Early surgical repair of this congenital anomaly prevents the psychological and functional problems associated with the deformity . Patients may develop various complications after primary palatoplasty including palatal fistula and velopharyngeal insufficiency (VPI) which are relatively common .

The main goal of cleft palate repair is to achieve normal speech and adequate velopharyngeal function with minimal effect on facial growth. The primary objective in the surgical repair of a cleft palate is the development of normal speech. Speech quality remains the most important standard for assessing clinical outcomes and the success of surgical procedures. Many surgical techniques for palate correction have been described determining the most effective technique for the surgical repair of palatal clefts continues to cause controversy .

The incidence of VPI post cleft palate repair is 20-30% of patients . If there is significant velopharyngeal dysfunction during normal speech development, many children learn to compensate for the lack of intraoral pressure. They produce a hoarse voice because of vocal fold adduction and sudden release. Compared with the adductor vocal fold palsy .

Registry
clinicaltrials.gov
Start Date
June 2024
End Date
February 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ragab Ahmed Ali

ASSISTANT LECTURE-pediatricSURGERY department-sohag university

Sohag University

Eligibility Criteria

Inclusion Criteria

  • •children more than 3 years old
  • Type of cleft: isolated cleft palate
  • Exclusion Criteri
  • Complicated cases by fistula or redo,
  • Missed follow up; less than 6 months.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Velopharyngeal Insufficiency Evaluation

Time Frame: 20 months

Velopharyngeal gap size in centimeters using nasopharyngoscopy.

Study Sites (1)

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