Otitis Media With Effusion
Conditions
Keywords
adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy
Brief summary
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
Interventions
PROCEDUREadenoidectomy, myringotomy, tubes insertion
adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)
PROCEDUREA-M
adenoidectomy and myringotomy alone
Sponsors
Aghia Sophia Children's Hospital of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OM-6 | one year post operative |
Secondary
| Measure | Time frame |
|---|---|
| tympanogram type B | one year |
Countries
Greece
Outcome results
None listed