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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
380
An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.
The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed.
Recurrence rate
Rate of OME recurrence
Time frame: 1 year after tube removal
Rate of repeated tube placement
proportion of patients who need repeated tube insertion
Time frame: 1 year after tube removal
AOM attacks
The number of acute otitis media attacks
Time frame: 1 year after tube removal
Otorrhea
Rate of Otorrhea
Time frame: 2 years after tube insertion
Pure tone audiometry
Change of pure tone audiometry thresholds compared with baseline
Time frame: 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.
Time frame: 2 years after tube insertion
Complications
Complications related to interventions of this study
Time frame: 2 years after tube insertion
Costs of OME-related visits and treatment
Medical expenses associated with OME
Time frame: Through study completion, an average of 2 years
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