Secretory Otitis Media in Adenoids Hypertrophy Patients
NCT ID: NCT04584073
Last Updated: 2020-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-10-31
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Adenoidectomy
Adenoidectomy
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.
Adenoidectomy and Myringotomy
Adenoidectomy and Myringotomy
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.
Adenoidectomy,Myringotomy and Tympanostomy tube application
Adenoidectomy and Myringotomy and Tympanostomy tube application
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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.
3 Years
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Ayman Ahmed Mostafa Abokrisha
Resident
Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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OME in adenoids hypertrophy
Identifier Type: -
Identifier Source: org_study_id
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