Secretory Otitis Media in Adenoids Hypertrophy Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Otitis Media With Effusion

Intervention / Treatment
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* Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adenoidectomy<br>Adenoidectomy | Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application<br>* 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.<br>|
| Active Comparator: Adenoidectomy and Myringotomy<br>Adenoidectomy and Myringotomy | Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application<br>* 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.<br>|
| Active Comparator: Adenoidectomy,Myringotomy and Tympanostomy tube application<br>Adenoidectomy and Myringotomy and Tympanostomy tube application | Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tympanogram | Tympanogram is test to measure the movement of tympanic membrane in response to changes in pressure. | after 3 months of surgery | 
| Audiogram | Audiogram is graph that shows hearing sensitivity | After 3 months of surgery |