Secretory Otitis Media in Adenoids Hypertrophy Patients

Status Not yet recruiting

Clinical 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04584073
Study type	Interventional
Source	Assiut University
Contact	Ahmed Ayman Ahmed, Resident
Phone	+201060451679
Email	Ahmed.20123777@med.au.edu.eg
Status	Not yet recruiting
Phase	N/A
Start date	October 2020
Completion date	December 2022

View Details

See also
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Not yet recruiting	`NCT03491098` - The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study	Early Phase 1
Completed	`NCT01082029` - Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children	Phase 4
Completed	`NCT00939796` - Clinical Study of the Tympanostomy Tube Delivery System	N/A
Recruiting	`NCT06316635` - Microplastics in Otitis Media With Effusion Material
Recruiting	`NCT02215681` - Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.