Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI
Anatomical Restoration Cleft Palate Technique (ARC) for Secondary Velopharyngeal Incompetence Post Cleft Palate Repair
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2022
CompletedFirst Submitted
Initial submission to the registry
November 15, 2022
CompletedFirst Posted
Study publicly available on registry
November 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2023
CompletedNovember 25, 2022
November 1, 2022
2 months
November 15, 2022
November 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Buccinator myomucosal flap with Furlow palatoplasty
EXPERIMENTALInterventions
Anatomical restoration concept using Buccinator myomucosal flap with Furlow palatoplasty is an effective technique for lengthening the palate and improving speech outcomes
Eligibility Criteria
You may qualify if:
- years old children with previous treated complete cleft palate with 2 flap palatoplasty technique, nonsyndromic.
- lip and palate repair performed by one craniofacial surgeon
You may not qualify if:
- Patients with syndromic cleft lip.
- Bilateral cleft lip
- Patient older younger 5 years.
- Associated Cardiac anomalies.
- Any systemic condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fayoum University
Al Fayyum, Egypt
Related Publications (1)
Aboulhassan MA, Elrouby IM, Refahee SM, Abd-El-Ghafour M. Effectiveness of secondary furlow palatoplasty with buccal myomucosal flap in correction of velopharyngeal insufficiency in patients with cleft palate. Clin Oral Investig. 2024 Apr 17;28(5):257. doi: 10.1007/s00784-024-05607-4.
PMID: 38630186DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
mamdouh aboelhassan, phd
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
November 15, 2022
First Posted
November 25, 2022
Study Start
November 11, 2022
Primary Completion
December 30, 2022
Study Completion
January 2, 2023
Last Updated
November 25, 2022
Record last verified: 2022-11