Secretory Otitis Media in Adenoids Hypertrophy Patients

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04584073

Collaborator

(none)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Otitis Media With Effusion	Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Adenoidectomy Adenoidectomy	Procedure: Adenoidectomy 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.
Active Comparator: Adenoidectomy and Myringotomy Adenoidectomy and Myringotomy	Procedure: Adenoidectomy 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.
Active Comparator: Adenoidectomy,Myringotomy and Tympanostomy tube application Adenoidectomy and Myringotomy and Tympanostomy tube application	Procedure: Adenoidectomy 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.

Arm

Intervention/Treatment

Active Comparator: Adenoidectomy

Adenoidectomy

Procedure: Adenoidectomy 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.

Active Comparator: Adenoidectomy and Myringotomy

Adenoidectomy and Myringotomy

Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application

Active Comparator: Adenoidectomy,Myringotomy and Tympanostomy tube application

Adenoidectomy and Myringotomy and Tympanostomy tube application

Procedure: Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application

Outcome Measures

Primary Outcome Measures

Tympanogram [after 3 months of surgery]
Tympanogram is test to measure the movement of tympanic membrane in response to changes in pressure.
Audiogram [After 3 months of surgery]
Audiogram is graph that shows hearing sensitivity

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Ayman Ahmed Mostafa Abokrisha, Resident, Assiut University

ClinicalTrials.gov Identifier:

NCT04584073

Other Study ID Numbers:

OME in adenoids hypertrophy

First Posted:

Oct 12, 2020

Last Update Posted:

Oct 12, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Otitis

Otitis Media

Otitis Media with Effusion

Hypertrophy

Study Results

No Results Posted as of Oct 12, 2020