search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media With Effusion

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

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

    First Posted
    September 26, 2020
    Last Updated
    October 9, 2020
    Sponsor
    Assiut University
    search

    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

    Learn more about this trial

    Secretory Otitis Media in Adenoids Hypertrophy Patients

    We'll reach out to this number within 24 hrs