Status:
COMPLETED
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Lead Sponsor:
Aghia Sophia Children's Hospital of Athens
Conditions:
Otitis Media With Effusion
Eligibility:
All Genders
3-12 years
Phase:
PHASE2
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, myrin...
Eligibility Criteria
Inclusion
- 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
- other health problems especially related with the condition eg cleft palate
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00629694
Start Date
September 1 2007
End Date
May 1 2009
Last Update
January 23 2012
Active Locations (1)
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1
Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens
Athens, Greece