Velopharyngeal InsufficiencyNCT03469973
Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction
An observational study of Velopharyngeal Insufficiency and Velopharyngeal Incompetence Due to Cleft Palate, run by Assiut University.
Trial summary
The velopharyngeal valve is a tridimensional muscular valve that is located between the oral and nasal cavities. It consists of the lateral and posterior pharyngeal walls as well as the soft palate. The role of the velopharyngeal valve is to separate the oral and nasal cavities during speech and swallowing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate
- What is being tested?
- Partial adenoidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 1 Sep 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will be conducted on Otorhinolaryngology Department, Assiut University Hospital, in the period between 1⁄5∕2018 and 1∕5⁄2020. The study will be carried on 40 consecutive cases.
Who may be able to join
- Adenoid enlargement causing Obstructive Sleep-Disordered Breathing (OSDB) with velopharyngeal insufficiency (proved or suspected).
Who cannot join
- Patients who had undergone any secondary corrective surgery for velopharyngeal insufficiency.
- Patients with craniofacial anomalies.
- Any associated medical comorbidity that contraindicates general anesthesia.
- Refusal of enrollment in the research by the patients or care givers.
About this study
The velopharyngeal valve is a tridimensional muscular valve that is located between the oral and nasal cavities. It consists of the lateral and posterior pharyngeal walls as well as the soft palate. The role of the velopharyngeal valve is to separate the oral and nasal cavities during speech and swallowing.
Read the detailed description
Velopharyngeal dysfunction is the inability to separate the oral and nasal cavities adequately during speech production through the actions of the velum and pharynx. Velopharyngeal dysfunction can be caused due to lack of tissue (velopharyngeal insufficiency) or lack of proper movement (velopharyngeal incompetence) of the walls. While Velopharyngeal dysfunction is commonly associated with cleft lip and palate, it can also be seen with submucous cleft and other noncleft conditions such as ablative palatal lesions, adenoidectomy, deafness or hearing loss, and cerebral palsy. In Velopharyngeal dysfunction, the incompletely closed velopharyngeal valve causes an inability to effectively manage the air stream for continuous speech causing hypernasal speech.
Adenoid hypertrophy may play a role in velopharyngeal closure especially in patients with palatal abnormality.
In 1958, Gibb indicated an incidence of hypernasality postadenoidectomy in approximately 1 of 2000 cases. Closure pattern of velopharyngeal valve in typical patients is velo-adenoidal rather than velopharyngeal closure. Adenoid mass is vital to velopharyngeal closure in such patients and removal necessitates a change in the pattern of velopharyngeal valving.
Trans-oral endoscopic partial (superior) adenoidectomy adenoidectomy enables the surgeon to inspect the velopharyngeal valve during the procedure; thus avoiding occurrence of velopharyngeal dysfunction.
- Being tested
- Partial adenoidectomy
- Medical subject headings
- Velopharyngeal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial adenoidectomyProcedure or surgery
The procedure will be completely visualized with a 45 degrees, 4- mm nasal endoscope; the upper part of the adenoid will be removed using the microdebrider, while the lower part will be preserves to maintain the velopharyngeal competence.
- Adenoid enlargement causing Obstructive Sleep-Disordered Breathing (OSDB) with velopharyngeal insufficiency (proved or suspected).
What is being measured
The primary outcome is the main question the study is designed to answer.
40 patients diagnosed by velopharyngeal insufficiency will go for partial adenoidectomy completely visualised by 45 degrees, 4 mm nasal endoscope. The adenoid will be removed by using microdeprider.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
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 Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basem Makram, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469973
- Sponsor's protocol ID
- BASEMM
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction
- ClinicalTrials.gov ID
- NCT03469973
- Acronym / sponsor ID
- BASEMM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 19 Mar 2018 (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.
The velopharyngeal valve is a tridimensional muscular valve that is located between the oral and nasal cavities. It consists of the lateral and posterior pharyngeal walls as well as the soft palate. The role of the velopharyngeal valve is to separate the oral and nasal cavities during speech and swallowing.
Detailed description
Velopharyngeal dysfunction is the inability to separate the oral and nasal cavities adequately during speech production through the actions of the velum and pharynx. Velopharyngeal dysfunction can be caused due to lack of tissue (velopharyngeal insufficiency) or lack of proper movement (velopharyngeal incompetence) of the walls. While Velopharyngeal dysfunction is commonly associated with cleft lip and palate, it can also be seen with submucous cleft and other noncleft conditions such as ablative palatal lesions, adenoidectomy, deafness or hearing loss, and cerebral palsy. In Velopharyngeal dysfunction, the incompletely closed velopharyngeal valve causes an inability to effectively manage the air stream for continuous speech causing hypernasal speech.
Adenoid hypertrophy may play a role in velopharyngeal closure especially in patients with palatal abnormality.
In 1958, Gibb indicated an incidence of hypernasality postadenoidectomy in approximately 1 of 2000 cases. Closure pattern of velopharyngeal valve in typical patients is velo-adenoidal rather than velopharyngeal closure. Adenoid mass is vital to velopharyngeal closure in such patients and removal necessitates a change in the pattern of velopharyngeal valving.
Trans-oral endoscopic partial (superior) adenoidectomy adenoidectomy enables the surgeon to inspect the velopharyngeal valve during the procedure; thus avoiding occurrence of velopharyngeal dysfunction.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted on Otorhinolaryngology Department, Assiut University Hospital, in the period between 1⁄5∕2018 and 1∕5⁄2020. The study will be carried on 40 consecutive cases.
Key inclusion criteria (1 listed)
- Adenoid enlargement causing Obstructive Sleep-Disordered Breathing (OSDB) with velopharyngeal insufficiency (proved or suspected).
Key exclusion criteria (4 listed)
- Patients who had undergone any secondary corrective surgery for velopharyngeal insufficiency.
- Patients with craniofacial anomalies.
- Any associated medical comorbidity that contraindicates general anesthesia.
- Refusal of enrollment in the research by the patients or care givers.
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 |
|---|---|---|
| Partial adenoidectomyThe procedure will be completely visualized with a 45 degrees, 4- mm nasal endoscope; the upper part of the adenoid will be removed using the microdebrider, while the lower part will be preserves to maintain the velopharyngeal competence. • Adenoid enlargement causing Obstructive Sleep-Disordered Breathing (OSDB) with velopharyngeal insufficiency (proved or suspected). | Procedure or surgery | – |
Primary outcome
40 patients diagnosed by velopharyngeal insufficiency will go for partial adenoidectomy completely visualised by 45 degrees, 4 mm nasal endoscope. The adenoid will be removed by using microdeprider.
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Velopharyngeal Insufficiency and Velopharyngeal Incompetence Due to Cleft Palate, run by Assiut University.
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 1 inclusion and 4 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
40 patients diagnosed by velopharyngeal insufficiency will go for partial adenoidectomy completely visualised by 45 degrees, 4 mm nasal endoscope. The adenoid will be removed by using microdeprider. (time frame: Up to 2 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 20 Mar 2018.