Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI

Velopharyngeal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626933
• Other study ID #: EC 2222
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: January 2, 2023

Study information

• Verified date: November 2022
• Source: Fayoum University
• Contact: shaimaa refahee, phd
• Phone: 01227407987
• Email: smr11[@]fayoum.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Velopharyngeal Insufficiency

Intervention

Procedure:
• Buccinator myomucosal flap with Furlow palatoplasty
Anatomical restoration concept using Buccinator myomucosal flap with Furlow palatoplasty is an effective technique for lengthening the palate and improving speech outcomes

Locations

Country	Name	City	State
Egypt	Fayoum University	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	grade of velopharyngeal closure during speech	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	immediate postoperative