Methods of Assessment of Adenoid Size
Primary Purpose
Adenoid Hypertrophy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
flexible nasoendoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoid Hypertrophy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients will undergo flexible nasoendoscopy
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03890692
Brief Title
Methods of Assessment of Adenoid Size
Official Title
Assesment of Adenoid Size by Flexible Nasoendoscopy and Lateral Neck Radiography and Its Relation to Clinical Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoid Hypertrophy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients will undergo flexible nasoendoscopy
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
flexible nasoendoscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
flexible nasoendoscopy in assessment degree of obstruction
Description
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.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ghada M Saad, MBBCH
Phone
01092018996
Ext
088+2
Email
ghada92mohamed@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed E Abdullah, MD
Phone
01002231361
Ext
088+2
Email
mohamedekram.osman@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
15971651
Citation
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.
Results Reference
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PubMed Identifier
30034661
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.
Results Reference
background
PubMed Identifier
25745612
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.
Results Reference
background
PubMed Identifier
20392530
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.
Results Reference
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Methods of Assessment of Adenoid Size
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