Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction

Velopharyngeal Insufficiency Clinical Trial

Official title:

Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03469973
• Other study ID #: BASEMM
• Status: Not yet recruiting
• First received: March 12, 2018
• Last updated: March 17, 2018
• Start date: June 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adenoid enlargement causing Obstructive Sleep-Disordered Breathing (OSDB) with velopharyngeal insufficiency (proved or suspected).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cleft Palate
• Velopharyngeal Incompetence Due to Cleft Palate
• Velopharyngeal Insufficiency

Intervention

Procedure:
• Partial adenoidectomy
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Up to 2 years