Adenoid HypertrophyNCT03890692
Methods of Assessment of Adenoid Size
A study testing flexible nasoendoscopy in people with Adenoid Hypertrophy, run by Assiut University.
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… Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Adenoid Hypertrophy
- What is being tested?
- flexible nasoendoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assesment of Adenoid Size by Flexible Nasoendoscopy and Lateral Neck Radiography and Its Relation to Clinical Symptoms
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
Read the 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.
- Conditions
- Adenoid Hypertrophy
- Being tested
- flexible nasoendoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible nasoendoscopyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| patients will undergo flexible nasoendoscopy | Experimental | 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 Receives: Procedure: flexible nasoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adenoid HypertrophyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ghada mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890692
- Sponsor's protocol ID
- AOAS
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 15971651Talebian 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.
PubMed 30034661Sharifkashani 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.
PubMed 25745612Saedi 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.
PubMed 20392530
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Adenoid Size by Flexible Nasoendoscopy and Lateral Neck Radiography and Its Relation to Clinical Symptoms
- ClinicalTrials.gov ID
- NCT03890692
- Acronym / sponsor ID
- AOAS
- Conditions
- Adenoid Hypertrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients will undergo flexible nasoendoscopy | Experimental | Procedure: flexible nasoendoscopyEndoscopy 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 |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flexible nasoendoscopynasopharyngeal 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 | Procedure or surgery | patients will undergo flexible nasoendoscopy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Background: PubMed 15971651Mlynarek 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.
- Background: PubMed 30034661Talebian 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.
- Background: PubMed 25745612Sharifkashani 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.
- Background: PubMed 20392530Saedi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing flexible nasoendoscopy in people with Adenoid Hypertrophy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ghada M Saad, MBBCH (01092018996 ext. 088+2, ghada92mohamed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flexible nasoendoscopy in assessment degree of obstruction (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03890692, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.