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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03890692
Other study ID # AOAS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date June 1, 2020

Study information

Verified date March 2019
Source Assiut University
Contact ghada M Saad, MBBCH
Phone 01092018996
Email ghada92mohamed@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic nasal obstruction due to adenoid hypertrophy is among the most common health problems affecting children, and adenoidectomy is one of the most common surgical procedures performed in this age group Because of difficulties associated with the use of the objective methods (such as nasopharyngeal endoscopy) in young children, the development of a reliable scale based on the child's symptoms to properly evaluate the need for surgical intervention would be of great value for clinicians. When adenoidectomy is being considered, the diagnosis and documentation of adenoidal hypertrophy become an important issue. Numerous modalities have been used for this task, including trans oral digital palpation and trans oral mirror examination; however, these methods are quite impractical with uncooperative younger children


Description:

Assessment of the nasopharynx and adenoids by fibreoptic examination bears the advantage of direct visualization of the postnasal space. In addition, previous studies have demonstrated that adenoid size, as determined by rhinoscopy, was well correlated with clinical symptoms such as nasal obstruction and snoring.

The aim of this study was to compare the effectiveness of lateral neck radiography and video rhinoscopy in assessing adenoid size .

Assessment of the reproducability of these modalities to associated symptoms and, thus, the severity of the disease.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 3 Years to 14 Years
Eligibility Inclusion Criteria:

- children aged 3 _ 14 years old

- clinical diagnosis of adenoid hypertrophy in the form of chronic oral respiration , nasal disorders and snoring

- recurrent otitis media

Exclusion Criteria:

1. patients diagnosed with nasal obstruction due to anatomic malformation ( congenital, choanal atresia, stenosis or septal deviation )

2. age less than 3 years or more than 14 years

3. patient with craniofacial malformation and down syndrome

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
flexible nasoendoscopy
nasopharyngeal endoscopy : After washing nasal cavities with a sterile physiologic solution to remove secretions or scabs, and decongesting them with an oxymetazoline solution in the subjects with turbinate hypertrophy, Endoscopy will be performed by passing the endoscope along either the floor of the nose or just under the middle turbinate. the condition of the nasal mucosa\ septum\ turbinates and the presence of discharge The postnasal space will be assessed . All abnormalities will be recorded .the images will be recorded and assessed separately by two independent otolaryngologists

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Mlynarek A, Tewfik MA, Hagr A, Manoukian JJ, Schloss MD, Tewfik TL, Choi-Rosen J. Lateral neck radiography versus direct video rhinoscopy in assessing adenoid size. J Otolaryngol. 2004 Dec;33(6):360-5. — View Citation

Saedi B, Sadeghi M, Mojtahed M, Mahboubi H. Diagnostic efficacy of different methods in the assessment of adenoid hypertrophy. Am J Otolaryngol. 2011 Mar-Apr;32(2):147-51. doi: 10.1016/j.amjoto.2009.11.003. Epub 2010 Apr 13. — View Citation

Sharifkashani S, Dabirmoghaddam P, Kheirkhah M, Hosseinzadehnik R. A new clinical scoring system for adenoid hypertrophy in children. Iran J Otorhinolaryngol. 2015 Jan;27(78):55-61. — View Citation

Talebian S, Sharifzadeh G, Vakili I, Golboie SH. Comparison of adenoid size in lateral radiographic, pathologic, and endoscopic measurements. Electron Physician. 2018 Jun 25;10(6):6935-6941. doi: 10.19082/6935. eCollection 2018 Jun. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary flexible nasoendoscopy in assessment degree of obstruction Endoscopy will be performed by passing the endoscope along either the floor of the nose or just under the middle turbinate. All abnormalities will be recorded. the degree of obstruction will be assesd according to anatomical structures ..such as torus tubarius, vomer, and the soft palate grade 1=none grade 2 reaching torus tubarius, grade 3 reaching torus tubarius and vomer, grade 4 reaching vomer and soft palate. baseline
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