A Phase 2 interventional study of adenoidectomy, myringotomy, tubes insertion and A-M in Otitis Media With Effusion, sponsored by Aghia Sophia Children's Hospital of Athens. Completed at 1 site in Greece. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2012-01-23.
Sponsored by Aghia Sophia Children's Hospital of Athens · Phase 2, Interventional, and Treatment
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
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
This study's enrollment of 52 is below the median of 80 across 61 interventional studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →Aghia Sophia Children's Hospital of Athens is the lead sponsor of 5 studies on the registry; none are open to participants now.
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: adenoidectomy, myringotomy, tubes insertion
Procedure: A-M
adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)
adenoidectomy and myringotomy alone
OM-6
Time frame: one year post operative
tympanogram type B
Time frame: one year
The record gives a start of Sep 2007, a primary completion of May 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Aghia Sophia Children's Hospital of Athens