Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT00629694
Status:
COMPLETED
Last Update Posted:
2012-01-23
First Post:
2008-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Sponsor:
Aghia Sophia Children's Hospital of Athens
Organization:
Study Overview
Official Title:
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: