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Secretory Otitis Media in Adenoids Hypertrophy Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04584073
Enrollment
150
Registered
2020-10-12
Start date
2020-10-31
Completion date
2022-12-31
Last updated
2020-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media With Effusion

Brief 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

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.

Interventions

PROCEDUREAdenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Tympanogramafter 3 months of surgeryTympanogram is test to measure the movement of tympanic membrane in response to changes in pressure.
AudiogramAfter 3 months of surgeryAudiogram is graph that shows hearing sensitivity

Contacts

Primary ContactAhmed Ayman Ahmed, Resident
Ahmed.20123777@med.au.edu.eg+201060451679
Backup ContactAhmed Abd El-Hay El-Hussiney, professor
alhussiniahmad@aun.edu.eg01220701447

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026