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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-T | Active Comparator |
| |
| A-M | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adenoidectomy, myringotomy, tubes insertion | Procedure | adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M) |
|
| Measure | Description | Time Frame |
|---|---|---|
| OM-6 | one year post operative |
| Measure | Description | Time Frame |
|---|---|---|
| tympanogram type B | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ioannis M Vlastos, MD | Aghia Sophia Children's Hospital of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens | Athens | Greece |
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| A-M | Procedure | adenoidectomy and myringotomy alone |
|
| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000233 | Adenoidectomy |
| D008876 | Middle Ear Ventilation |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010030 | Ostomy |
| D013506 | Otologic Surgical Procedures |
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