Clinical Trial: Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
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 Summary:
Sponsor: Aghia Sophia Children's Hospital of Athens
Current Primary Outcome: OM-6 [ Time Frame: one year post operative ]
Original Primary Outcome: Same as current
Current Secondary Outcome: tympanogram type B [ Time Frame: one year ]
Original Secondary Outcome: Same as current
Information By: Aghia Sophia Children's Hospital of Athens
Dates:
Date Received: February 27, 2008
Date Started: September 2007
Date Completion:
Last Updated: January 20, 2012
Last Verified: January 2012