Velopharyngeal InsufficiencyNCT06343623
Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure
A study testing myomucosal resection and direct closure and superiorly based flap in people with Velopharyngeal Insufficiency, run by Minia University at 1 site in Egypt.
Trial summary
Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Velopharyngeal Insufficiency
- What is being tested?
- myomucosal resection and direct closure and superiorly based flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2018to 16 Oct 2022
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - Patients have velopharyngeal insufficiency.
- Age range 4-10 years
Who cannot join
- - Syndromic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall
Read the detailed description
Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall
- Conditions
- Velopharyngeal Insufficiency
- Being tested
- myomucosal resection and direct closure, superiorly based flap
- Medical subject headings
- Velopharyngeal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myomucosal resection and direct closureProcedure or surgery
myomucosal resection and direct closure
superiorly based flapProcedure or surgery
superiorly based pharyngeal flap
| Study group | Role | What they receive |
|---|---|---|
| superiorly based flap | Active comparator | superiorly bases pharyngeal flap Receives: Procedure: superiorly based flap |
| myomucosal resection and direct closure | Experimental | myomucosal resection and direct closure Receives: Procedure: myomucosal resection and direct closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the speech outcome
Improvement in the speech outcome using auditory perception assessment and videonasoendoscopy
Measured: 4 years
Secondary outcomes (1)
obstructive sleep apnea
obstructive sleep apnea using respiratory function test
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start12 Oct 2018
- Primary completion16 Oct 2022
- Study completion16 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Velopharyngeal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Minia 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mstafa Hassan Sewefy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343623
- Sponsor's protocol ID
- fac.med.2018.15
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure
- ClinicalTrials.gov ID
- NCT06343623
- Acronym / sponsor ID
- fac.med.2018.15
- Conditions
- Velopharyngeal Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 16 Oct 2022 (actual)
- Study completion
- 16 Oct 2022 (actual)
- First posted
- 2 Apr 2024 (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.
Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall
Detailed description
Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| superiorly based flap | Active comparator | Procedure: superiorly based flapsuperiorly bases pharyngeal flap |
| myomucosal resection and direct closure | Experimental | Procedure: myomucosal resection and direct closuremyomucosal resection and direct closure |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- - Patients have velopharyngeal insufficiency.
- Age range 4-10 years
Key exclusion criteria (1 listed)
- - Syndromic patients.
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 |
|---|---|---|
| myomucosal resection and direct closuremyomucosal resection and direct closure | Procedure or surgery | myomucosal resection and direct closure |
| superiorly based flapsuperiorly based pharyngeal flap | Procedure or surgery | superiorly based flap |
Primary outcome
Improvement in the speech outcome
Time frame: 4 years
Improvement in the speech outcome using auditory perception assessment and videonasoendoscopy
1 secondary outcome
obstructive sleep apnea
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myomucosal resection and direct closure and superiorly based flap in people with Velopharyngeal Insufficiency, run by Minia 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 1 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: finished, as of the sponsor's last update on 2 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the speech outcome (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.