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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05273853
Other study ID # DAHAllah
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 4, 2022
Est. completion date December 1, 2022

Study information

Verified date March 2022
Source Sohag University
Contact Dina A Hasb Allah, Resident
Phone +201286000163
Email dina_ewaida_post@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech.


Description:

Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech. It also contributes to the pathogenesis of rhinosinusitis and recurrent otitis media. However, the adenoid lies in the posterior nasopharyngeal wall and may act as a pad against the palate facilitating velopharyngeal closure, especially in patients with palatal abnormalities; Its presence can compensate for a short or poorly mobile palate. Following adenoidectomy, compensation is eliminated and velopharyngeal insufficiency (VPI) may result. Therefore, patients with palatal abnormalities (such as poor palatal mobility, short palate, occult submucosal cleft palate, scarred palate after previous tonsillectomy, and repaired cleft palate) are at high risk to develop hypernasality after complete adenoidectomy, and in such situations conservative or partial adenoidectomy is performed


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 1, 2022
Est. primary completion date August 4, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria: 1. Patient with symptoms of adenoid hypertrophy. 2. High risk to VPI: 1. Short palate. 2. Scarred palate after previous tonsillectomy. 3. Occult submucous cleft. 4. Deep pharynx. 5. Repaired cleft palate. Exclusion Criteria: - Any neurological deficit, muscular disorder or structural defects of the palate (as cleft palate).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Partial Adenoidectomy
Partial removal of adenoid

Locations

Country Name City State
Egypt Sohag Faculty of Medicine Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Rowe MR, D'Antonio LL. Velopharyngeal dysfunction: evolving developments in evaluation. Curr Opin Otolaryngol Head Neck Surg. 2005 Dec;13(6):366-70. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Speech Outcome Change of a degree of Nasal Tone during speech 1 month after operation
Primary Speech Outcome Change of a degree of Nasal Tone during speech 3 months after operation
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