Back to resultsBuccinator Myomucosal Flap With Furlow Palatoplasty and VPI
Primary Purpose
Velopharyngeal Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Buccinator myomucosal flap with Furlow palatoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Velopharyngeal Insufficiency
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
Sites / Locations
- Fayoum UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Buccinator myomucosal flap with Furlow palatoplasty
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05626933
Brief Title
Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI
Official Title
Anatomical Restoration Cleft Palate Technique (ARC) for Secondary Velopharyngeal Incompetence Post Cleft Palate Repair
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Velopharyngeal Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Buccinator myomucosal flap with Furlow palatoplasty
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Buccinator myomucosal flap with Furlow palatoplasty
Intervention Description
Anatomical restoration concept using Buccinator myomucosal flap with Furlow palatoplasty is an effective technique for lengthening the palate and improving speech outcomes
Primary Outcome Measure Information:
Title
grade of velopharyngeal closure during speech
Description
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
Time Frame
immediate postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shaimaa refahee, phd
Phone
01227407987
Email
smr11@fayoum.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
mamdouh aboelhassan, phd
Facility Information:
Facility Name
Fayoum University
City
Fayoum
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shaimaa refahee, phd
Phone
01227407987
Email
smr11@fayoum.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI
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