- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03890692
Methods of Assessment of Adenoid Size
Assesment of Adenoid Size by Flexible Nasoendoscopy and Lateral Neck Radiography and Its Relation to Clinical Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ghada M Saad, MBBCH
- Phone Number: 088+2 01092018996
- Email: ghada92mohamed@gmail.com
Study Contact Backup
- Name: Mohamed E Abdullah, MD
- Phone Number: 088+2 01002231361
- Email: mohamedekram.osman@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- patients diagnosed with nasal obstruction due to anatomic malformation ( congenital, choanal atresia, stenosis or septal deviation )
- age less than 3 years or more than 14 years
- patient with craniofacial malformation and down syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients will undergo flexible nasoendoscopy
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
|
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,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
flexible nasoendoscopy in assessment degree of obstruction
Time Frame: baseline
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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. doi: 10.2310/7070.2004.03074.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOAS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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