An observational study in Velopharyngeal Insufficiency and Velopharyngeal Incompetence Due to Cleft Palate, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2018-03-20.
Sponsored by Assiut University · Observational
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.
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.
20 studies on the registry are indexed under Velopharyngeal Insufficiency; 9 are open to participants now.
Browse Velopharyngeal Insufficiency studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
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Exclusion Criteria:
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).
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
No study locations are listed for this record.
Start is estimated for Jun 2018; primary completion for May 2020, 23 months later.
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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Velopharyngeal Insufficiency →