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OpenTrials
Completed

NCT Number: NCT00629694

Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy

It is not unusual for several children operated for severe adenoid hyperthrophy causing breathing problems to have otitis media with effusion simultaneously. It is unknown whether adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy alone in terms of otitis media related quality of life and recurrence of otitis media several months after the operation. For this purpose a randomized trial is conducted including children operated for adenoid hyperthrophy and whose otitis media with effusion had caused minimal or no symptoms so far

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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens

Athens, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children operated for their adenoid hyperthrophy with an adenoid size of 3 (measured in a scale of 1-3 intraoperatively or from lateral neck x-ray) and otitis media with effusion causing an average air-bone gap of greater than 20db. Children should be otherwise healthy with an ASA score of I and between 3-12 years old of age

Exclusion criteria

  • other health problems especially related with the condition eg cleft palate

Treatment and study plan

adenoidectomy, myringotomy, tubes insertion

Procedure

adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)

A-M

Procedure

adenoidectomy and myringotomy alone

Primary outcomes

  1. OM-6

    Time frame: one year post operative

Secondary outcomes

  1. tympanogram type B

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Aghia Sophia Children's Hospital of Athens

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2008
Registry last updated
Jan 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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