Secretory Otitis Media in Adenoids Hypertrophy Patients
Primary Purpose
Otitis Media With Effusion
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media With Effusion
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Adenoidectomy
Adenoidectomy and Myringotomy
Adenoidectomy,Myringotomy and Tympanostomy tube application
Arm Description
Adenoidectomy
Adenoidectomy and Myringotomy
Adenoidectomy and Myringotomy and Tympanostomy tube application
Outcomes
Primary Outcome Measures
Tympanogram
Tympanogram is test to measure the movement of tympanic membrane in response to changes in pressure.
Audiogram
Audiogram is graph that shows hearing sensitivity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04584073
Brief Title
Secretory Otitis Media in Adenoids Hypertrophy Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adenoidectomy
Arm Type
Active Comparator
Arm Description
Adenoidectomy
Arm Title
Adenoidectomy and Myringotomy
Arm Type
Active Comparator
Arm Description
Adenoidectomy and Myringotomy
Arm Title
Adenoidectomy,Myringotomy and Tympanostomy tube application
Arm Type
Active Comparator
Arm Description
Adenoidectomy and Myringotomy and Tympanostomy tube application
Intervention Type
Procedure
Intervention Name(s)
Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tympanogram
Description
Tympanogram is test to measure the movement of tympanic membrane in response to changes in pressure.
Time Frame
after 3 months of surgery
Title
Audiogram
Description
Audiogram is graph that shows hearing sensitivity
Time Frame
After 3 months of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Ayman Ahmed, Resident
Phone
+201060451679
Email
Ahmed.20123777@med.au.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abd El-Hay El-Hussiney, professor
Phone
01220701447
Email
alhussiniahmad@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20399511
Citation
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.
Results Reference
result
PubMed Identifier
29798016
Citation
Xu 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 Reference
result
PubMed Identifier
26248446
Citation
Tian 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 Reference
result
PubMed Identifier
31127413
Citation
Hao 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. Erratum In: Eur Arch Otorhinolaryngol. 2019 Jun 18;:
Results Reference
result
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Secretory Otitis Media in Adenoids Hypertrophy Patients
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