Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Phase 2
Completed
- Conditions
- Otitis Media With Effusion
- Interventions
- Procedure: A-MProcedure: adenoidectomy, myringotomy, tubes insertion
- Registration Number
- NCT00629694
- Lead Sponsor
- Aghia Sophia Children's Hospital of Athens
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A-M A-M - A-T adenoidectomy, myringotomy, tubes insertion -
- Primary Outcome Measures
Name Time Method OM-6 one year post operative
- Secondary Outcome Measures
Name Time Method tympanogram type B one year
Trial Locations
- Locations (1)
Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens
🇬🇷Athens, Greece