NCT00629694

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Aghia Sophia Children's Hospital of Athens · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Otitis Media With Effusion

Interventions

Type	Name	Description
PROCEDURE	adenoidectomy, myringotomy, tubes insertion	adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)
PROCEDURE	A-M	adenoidectomy and myringotomy alone

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-03-06
• Last updated: 2012-01-23

Locations

1 site across 1 country: Greece