Otitis Media With EffusionNCT04584073
Secretory Otitis Media in Adenoids Hypertrophy Patients
A study testing Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application in people with Otitis Media With Effusion, run by Assiut University.
Trial summary
This study aims to compare the fate of Secretory Otitis Media in patients with adenoids hypertrophy undergoing Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Dec 2022
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any case presented with Secretory Otitis Media with adenoids hypertrophy with the following criteria
- Age is between 3 to 17 years old
- With or without chronic tonsillitis
- conductive hearing loss
- Recurrent upper respiratory tract infection
- Dull tympanic membrane on otoscopy (absent cone of light), decreased mobility of tympanic membrane
- Type B tympanogram on tympanometry
- OME not responding to medical treatment for three months
Who cannot join
- Patients with the following criteria will be excluded from the study
- Previous Myringotomy with or without Tympanostomy Tube application
- Previous adenoidectomy or tonsillectomy
- Previous ear surgery, cleft palate, Down's syndrome, congenital malformation of the ear and cholesteatoma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between the Fate of Secretory Otitis Media in Patients With Adenoids Hypertrophy Undergoing Adenoidectomy Alone or With Myringotomy or With Myringotomy and Tympanostomy Tube Application
This study aims to compare the fate of Secretory Otitis Media in patients with adenoids hypertrophy undergoing Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application
Read the detailed description
Otitis media with effusion (OME) is one of the most common diseases during childhood . It is defined as collection of non-purulent effusion (mucoid or serous) in the middle ear space without signs of acute infection. It's synomus are serous otitis media, secretory otitis media or glue ear. Adenoid hypertrophy can cause mechanical obstruction of the Eustachian tube which plays an important role in the pathogenesis of OME.
Management of OME consisted of many varieties; 1- Auto inflation, 2- Medical treatment and 3- Surgical. Surgical treatment indicated in cases where the effusion does not resolve spontaneously or failed medical treatment for 3 months and the main purpose of surgery is to restore middle ear aeration. Treatment options are Adenoidectomy with or without Myringotomy or Myringotomy and Tympanostomy tube application.
The aim of this study is to compare the efficacy of each surgical option in management of otitis media with effusion. This study will be carried out in ENT department of Assiut university hospital on 150 child diagnosed as persistent otitis media with effusion due to adenoid enlargement and they will be categorized randomly into three groups (50 cases per each). Group I will undergo Adenoidectomy alone, group II will undergo Adenoidectomy and Myringotomy and group III will undergo Adenoidectomy and Myringotomy and Tympanostomy tube application. All patients will be subjected to full ENT examination and audiological evaluation. Postoperative evaluation will be done for all patients for 3 months through clinical and audiological evaluation.
- Conditions
- Otitis Media With Effusion
- Being tested
- Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube applicationProcedure or surgery
Adenoidectomy with or without tonsillectomy when indicated will be performed. simple Myringotomy incision will be done in the antero-inferior quadrant of pars tensa of both tympanic membranes. Middle ear fluids will be aspirated. Tympanostomy tube application will be done.
| Study group | Role | What they receive |
|---|---|---|
| Adenoidectomy | Active comparator | Adenoidectomy Receives: Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application |
| Adenoidectomy and Myringotomy | Active comparator | Adenoidectomy and Myringotomy Receives: Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application |
| Adenoidectomy,Myringotomy and Tympanostomy tube application | Active comparator | Adenoidectomy and Myringotomy and Tympanostomy tube application Receives: Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tympanogram
Tympanogram is test to measure the movement of tympanic membrane in response to changes in pressure.
Measured: after 3 months of surgery
Audiogram
Audiogram is graph that shows hearing sensitivity
Measured: After 3 months of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (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 Otitis Media With EffusionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ayman Ahmed Mostafa Abokrisha, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584073
- Sponsor's protocol ID
- OME in adenoids hypertrophy
- Status last verified
- Sep 2020
- First submitted
- 26 Sep 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Popova D, Varbanova S, Popov TM. Comparison between myringotomy and tympanostomy tubes in combination with adenoidectomy in 3-7-year-old children with otitis media with effusion. Int J Pediatr Otorhinolaryngol. 2010 Jul;74(7):777-80. doi: 10.1016/j.ijporl.2010.03.054.
PubMed 20399511Xu WM, Ye YH. [Effect of tympanostomy tube insertion with adenoidectomy for children with recurrent otitis media with effusion]. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2016 Dec;30(23):1873-1875. doi: 10.13201/j.issn.1001-1781.2016.23.009. Chinese.
PubMed 29798016Tian X, Liu Y, Wang M, Liu H. [A systematic review of adenoidectomy in the treatment of otitis media with effusion in children]. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2014 Apr;29(8):723-5. Chinese.
PubMed 26248446Hao J, Chen M, Liu B, Yang Y, Liu W, Ma N, Han Y, Liu Q, Ni X, Zhang J. Compare two surgical interventions for otitis media with effusion in young children. Eur Arch Otorhinolaryngol. 2019 Aug;276(8):2125-2131. doi: 10.1007/s00405-019-05421-9. Epub 2019 May 24.
PubMed 31127413
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Fate of Secretory Otitis Media in Patients With Adenoids Hypertrophy Undergoing Adenoidectomy Alone or With Myringotomy or With Myringotomy and Tympanostomy Tube Application
- ClinicalTrials.gov ID
- NCT04584073
- Acronym / sponsor ID
- OME in adenoids hypertrophy
- Conditions
- Otitis Media With Effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Oct 2020 (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.
This study aims to compare the fate of Secretory Otitis Media in patients with adenoids hypertrophy undergoing Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application
Detailed description
Otitis media with effusion (OME) is one of the most common diseases during childhood . It is defined as collection of non-purulent effusion (mucoid or serous) in the middle ear space without signs of acute infection. It's synomus are serous otitis media, secretory otitis media or glue ear. Adenoid hypertrophy can cause mechanical obstruction of the Eustachian tube which plays an important role in the pathogenesis of OME.
Management of OME consisted of many varieties; 1- Auto inflation, 2- Medical treatment and 3- Surgical. Surgical treatment indicated in cases where the effusion does not resolve spontaneously or failed medical treatment for 3 months and the main purpose of surgery is to restore middle ear aeration. Treatment options are Adenoidectomy with or without Myringotomy or Myringotomy and Tympanostomy tube application.
The aim of this study is to compare the efficacy of each surgical option in management of otitis media with effusion. This study will be carried out in ENT department of Assiut university hospital on 150 child diagnosed as persistent otitis media with effusion due to adenoid enlargement and they will be categorized randomly into three groups (50 cases per each). Group I will undergo Adenoidectomy alone, group II will undergo Adenoidectomy and Myringotomy and group III will undergo Adenoidectomy and Myringotomy and Tympanostomy tube application. All patients will be subjected to full ENT examination and audiological evaluation. Postoperative evaluation will be done for all patients for 3 months through clinical and audiological evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adenoidectomy | Active comparator | Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube applicationAdenoidectomy |
| Adenoidectomy and Myringotomy | Active comparator | Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube applicationAdenoidectomy and Myringotomy |
| Adenoidectomy,Myringotomy and Tympanostomy tube application | Active comparator | Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube applicationAdenoidectomy and Myringotomy and Tympanostomy tube application |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Any case presented with Secretory Otitis Media with adenoids hypertrophy with the following criteria
- Age is between 3 to 17 years old
- With or without chronic tonsillitis
- conductive hearing loss
- Recurrent upper respiratory tract infection
Key exclusion criteria (4 listed)
- Patients with the following criteria will be excluded from the study
- Previous Myringotomy with or without Tympanostomy Tube application
- Previous adenoidectomy or tonsillectomy
- Previous ear surgery, cleft palate, Down's syndrome, congenital malformation of the ear and cholesteatoma.
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 |
|---|---|---|
| Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube applicationAdenoidectomy with or without tonsillectomy when indicated will be performed. simple Myringotomy incision will be done in the antero-inferior quadrant of pars tensa of both tympanic membranes. Middle ear fluids will be aspirated. Tympanostomy tube application will be done. | Procedure or surgery | Adenoidectomy, Adenoidectomy and Myringotomy, Adenoidectomy,Myringotomy and Tympanostomy tube application |
Primary outcome
Tympanogram
Time frame: after 3 months of surgery
Tympanogram is test to measure the movement of tympanic membrane in response to changes in pressure.
Audiogram
Time frame: After 3 months of surgery
Audiogram is graph that shows hearing sensitivity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Results publication: PubMed 20399511Popova D, Varbanova S, Popov TM. Comparison between myringotomy and tympanostomy tubes in combination with adenoidectomy in 3-7-year-old children with otitis media with effusion. Int J Pediatr Otorhinolaryngol. 2010 Jul;74(7):777-80. doi: 10.1016/j.ijporl.2010.03.054.
- Results publication: PubMed 29798016Xu WM, Ye YH. [Effect of tympanostomy tube insertion with adenoidectomy for children with recurrent otitis media with effusion]. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2016 Dec;30(23):1873-1875. doi: 10.13201/j.issn.1001-1781.2016.23.009. Chinese.
- Results publication: PubMed 26248446Tian X, Liu Y, Wang M, Liu H. [A systematic review of adenoidectomy in the treatment of otitis media with effusion in children]. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2014 Apr;29(8):723-5. Chinese.
- Results publication: PubMed 31127413Hao J, Chen M, Liu B, Yang Y, Liu W, Ma N, Han Y, Liu Q, Ni X, Zhang J. Compare two surgical interventions for otitis media with effusion in young children. Eur Arch Otorhinolaryngol. 2019 Aug;276(8):2125-2131. doi: 10.1007/s00405-019-05421-9. Epub 2019 May 24.
- Individual participant dataSharing planned: Undecided
Related trials for Otitis Media With Effusion
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Not yet recruiting
EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Otitis Media With Effusion (OME), Eustachian Tube Dysfunction
Recruiting
SWIR Otoscopy Study
Otitis Media, Otitis Media Chronic
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 Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application in people with Otitis Media With Effusion, 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 8 inclusion and 4 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 12 Oct 2020. 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 Ahmed Ayman Ahmed, Resident (+201060451679, Ahmed.20123777@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tympanogram (time frame: after 3 months of surgery). The study lists 2 primary outcomes in all. 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 NCT04584073, 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 12 Oct 2020.