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| Name | Class |
|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Children's Hospital of Fudan University | OTHER |
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This study aims to verify the efficacy of adjuvant adenoidectomy for children with chronic OME who become candidates for tympanostomy tube placement, and explore potential factors associated with the efficacy of adjuvant adenoidectomy.
Otitis media with effusion is a common condition in children, and tympanostomy tube placement is the first-line treatment for those who requires surgical interventions. Adenoidectomy proves to be helpful to children over 4 years old, but the risks of adjuvant surgery is believed to somehow offset its benefits. This study is meant to verify if concurrent adenoidectomy provides extra benefits in resolving MEE, reducing AOM, and improving hearing and patients' quality of life to children who become candidates for TT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TT | Active Comparator | Participants only receive tympanostomy tube placement. |
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| Ad+TT | Experimental | Participants will receive tympanostomy tube placement and concurrent adenoidectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tympanostomy tube placement | Procedure | An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted. |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Rate of OME recurrence | 1 year after tube removal |
| Rate of repeated tube placement | proportion of patients who need repeated tube insertion | 1 year after tube removal |
| Measure | Description | Time Frame |
|---|---|---|
| AOM attacks | The number of acute otitis media attacks | 1 year after tube removal |
| Otorrhea | Rate of Otorrhea | 2 years after tube insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiqian Yu, PhD | Contact | 86-13636423139 | yhq925@163.com | |
| Fangzhou Yu, MD | Contact | 86-18321719732 | 13301050317@fudan.edu.cn |
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| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000233 | Adenoidectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| adenoidectomy | Procedure | The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed. |
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| Pure tone audiometry | Change of pure tone audiometry thresholds compared with baseline | 2 years after tube insertion |
| Otitis Media-6 and Pediatric Sleep Questionnaire | Change of questionnaire score. Otitis Media-6 score ranges from 6 to 42, and higher scores mean worse outcomes. Pediatric Sleep Questionnaire score ranges from 0 to 22, and higher scores mean worse outcomes. | 2 years after tube insertion |
| Complications | Complications related to interventions of this study | 2 years after tube insertion |
| Costs of OME-related visits and treatment | Medical expenses associated with OME | Through study completion, an average of 2 years |