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Clinical Trials/NCT05626933
NCT05626933
Recruiting
Not Applicable

Anatomical Restoration Cleft Palate Technique (ARC) for Secondary Velopharyngeal Incompetence Post Cleft Palate Repair

Fayoum University1 site in 1 country20 target enrollmentNovember 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Velopharyngeal Insufficiency
Sponsor
Fayoum University
Enrollment
20
Locations
1
Primary Endpoint
grade of velopharyngeal closure during speech
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Nasopharyngoscopic examination of the 20 patients with secondary VPI following 2 flap palatoplasty will be 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 and after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty

Registry
clinicaltrials.gov
Start Date
November 11, 2022
End Date
January 2, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shaimaa Mohsen

principal investigator

Fayoum University

Eligibility Criteria

Inclusion Criteria

  • 5-6 years old children with previous treated complete cleft palate with 2 flap palatoplasty technique, nonsyndromic.
  • lip and palate repair performed by one craniofacial surgeon

Exclusion Criteria

  • Patients with syndromic cleft lip.
  • Bilateral cleft lip
  • Patient older younger 5 years.
  • Associated Cardiac anomalies.
  • Any systemic condition

Outcomes

Primary Outcomes

grade of velopharyngeal closure during speech

Time Frame: immediate postoperative

Nasopharyngoscopic examination of the patients with secondary velopharyngeal insufficiency ( VPI) following two flap palatoplasty cleft palate repairs will be done for assessment of velopharyngeal closure grade during speech after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty

Study Sites (1)

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