NCT04584073

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 12, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 26, 2020

Last Update Submit

October 9, 2020

Conditions

Otitis Media With Effusion

Outcome Measures

Primary Outcomes (2)

  • Tympanogram

    Tympanogram is test to measure the movement of tympanic membrane in response to changes in pressure.

    after 3 months of surgery

  • Audiogram

    Audiogram is graph that shows hearing sensitivity

    After 3 months of surgery

Study Arms (3)

Adenoidectomy

ACTIVE COMPARATOR

Adenoidectomy

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

Adenoidectomy and Myringotomy

ACTIVE COMPARATOR

Adenoidectomy and Myringotomy

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

Adenoidectomy,Myringotomy and Tympanostomy tube application

ACTIVE COMPARATOR

Adenoidectomy and Myringotomy and Tympanostomy tube application

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

Interventions

Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube applicationPROCEDURE

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.

AdenoidectomyAdenoidectomy and MyringotomyAdenoidectomy,Myringotomy and Tympanostomy tube application

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 20399511RESULT

  • 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.

    PMID: 29798016RESULT

  • 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.

    PMID: 26248446RESULT

  • 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.

    PMID: 31127413RESULT

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Adenoidectomy

Condition Hierarchy (Ancestors)

Otitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Ahmed Ayman Ahmed, Resident

CONTACT

+201060451679Ahmed.20123777@med.au.edu.eg

Ahmed Abd El-Hay El-Hussiney, professor

CONTACT

01220701447alhussiniahmad@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 26, 2020

First Posted

October 12, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

October 12, 2020

Record last verified: 2020-09