Secretory Otitis Media in Adenoids Hypertrophy Patients

• ClinicalTrials.gov Identifier: NCT04584073
• Recruitment Status: Not yet recruiting
• First Posted: October 12, 2020
• Last Update Posted: October 12, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): Ahmed Ayman Ahmed Mostafa Abokrisha, Assiut University

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	Not Applicable

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 (Clinical Trial)
• Estimated 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
• Estimated Study Start Date: October 2020
• Estimated Primary Completion Date: October 2022
• Estimated Study Completion Date: December 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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Ahmed Ayman Ahmed, Resident; +201060451679; Ahmed.20123777@med.au.edu.eg

Contact: Ahmed Abd El-Hay El-Hussiney, professor; 01220701447; alhussiniahmad@aun.edu.eg

Sponsors and Collaborators

Assiut University

More Information

Publications of Results:

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 Chung 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 Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2014 Apr;29(8):723-5. Review. 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. Erratum in: Eur Arch Otorhinolaryngol. 2019 Jun 18;:.

• Responsible Party: Ahmed Ayman Ahmed Mostafa Abokrisha, Resident, Assiut University
• ClinicalTrials.gov Identifier: NCT04584073
• Other Study ID Numbers: OME in adenoids hypertrophy
• First Posted: October 12, 2020
• Last Update Posted: October 12, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Otitis; Otitis Media; Otitis Media with Effusion; Hypertrophy; Ear Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical