Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction

NCT03469973 | Unknown

• 1 other identifier: BASEMM
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Velopharyngeal Insufficiency; Velopharyngeal Incompetence Due to Cleft Palate

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Partial adenoidectomy PROCEDURE

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Velopharyngeal Insufficiency

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Diseases; Stomatognathic System Abnormalities; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: June 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 20, 2018

Record last verified: 2018-03