Velopharyngeal InsufficiencyNCT05626933
Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI
A study testing Buccinator myomucosal flap with Furlow palatoplasty in people with Velopharyngeal Insufficiency, run by Fayoum University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Velopharyngeal Insufficiency
- What is being tested?
- Buccinator myomucosal flap with Furlow palatoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2022to 2 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patients with syndromic cleft lip.
- Bilateral cleft lip
- Patient older younger 5 years.
- Associated Cardiac anomalies.
- Any systemic condition
Trial locations and contacts
1 site in 1 country.
mamdouh aboelhassan, phd contact
Egypt1 site, 1 recruiting
- Recruiting
Fayoum University
Al Fayyum
shaimaa refahee, phd, 01227407987, smr11@fayoum.edu.eg
About this study
Official title: Anatomical Restoration Cleft Palate Technique (ARC) for Secondary Velopharyngeal Incompetence Post Cleft Palate Repair
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
- Conditions
- Velopharyngeal Insufficiency
- Being tested
- Buccinator myomucosal flap with Furlow palatoplasty
- Medical subject headings
- Velopharyngeal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccinator myomucosal flap with Furlow palatoplastyProcedure or surgery
Anatomical restoration concept using Buccinator myomucosal flap with Furlow palatoplasty is an effective technique for lengthening the palate and improving speech outcomes
| Study group | Role | What they receive |
|---|---|---|
| Buccinator myomucosal flap with Furlow palatoplasty | Experimental | Not described Receives: Procedure: Buccinator myomucosal flap with Furlow palatoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediate postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start11 Nov 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion2 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Velopharyngeal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626933
- Sponsor's protocol ID
- EC 2222
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 25 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38630186
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Restoration Cleft Palate Technique (ARC) for Secondary Velopharyngeal Incompetence Post Cleft Palate Repair
- ClinicalTrials.gov ID
- NCT05626933
- Acronym / sponsor ID
- EC 2222
- Conditions
- Velopharyngeal Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 2 Jan 2023 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buccinator myomucosal flap with Furlow palatoplasty | Experimental | Procedure: Buccinator myomucosal flap with Furlow palatoplasty |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Patients with syndromic cleft lip.
- Bilateral cleft lip
- Patient older younger 5 years.
- Associated Cardiac anomalies.
- Any systemic condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccinator myomucosal flap with Furlow palatoplastyAnatomical restoration concept using Buccinator myomucosal flap with Furlow palatoplasty is an effective technique for lengthening the palate and improving speech outcomes | Procedure or surgery | Buccinator myomucosal flap with Furlow palatoplasty |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Derived from this study: PubMed 38630186Aboulhassan 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.
- Individual participant dataSharing planned: Undecided
Related trials for Velopharyngeal Insufficiency
RecruitingObservational study
Donor Site Morbidity and Buccinator Muscle Integrity After Buccinator Myomucosal Flap Surgery in Patients With Velopharyngeal Incompetence
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Effect of Velopharyngeal Gap Size on Laryngeal Morphology and Vocal Function in Children With VPI
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Expiratory Muscle Strength Training for Hypernasal Speech in Children
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Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI
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Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study
Velopharyngeal Insufficiency, Head and Neck Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mamdouh aboelhassan, phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccinator myomucosal flap with Furlow palatoplasty in people with Velopharyngeal Insufficiency, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shaimaa refahee, phd (01227407987, smr11@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grade of velopharyngeal closure during speech (time frame: immediate postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05626933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.