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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoid Hypertrophy

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    March 17, 2019
    Last Updated
    March 25, 2019
    Sponsor
    Assiut University
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    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
    background
    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
    background

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    Methods of Assessment of Adenoid Size

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