Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Adjuvant Adenoidectomy Plus Tympanostomy Tube Placement for the Treatment of Chronic OME in Children

Conditions
-----------------
Otitis Media With Effusion in Children

Intervention / Treatment
-----------------
* Procedure: tympanostomy tube placement
* Procedure: adenoidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Children 4-12 years of age. 2. Diagnosed with chronic OME. Diagnostic criteria: I. Middle ear effusion detected by otoscopy; II. Type B or C tympanograms; III. Symptoms/signs of OME persisted for >3 months; 3. Documented hearing loss ≥20dB (average threshold of 500Hz, 1000Hz and 2kHz in pure tone audiometry). 4. Adenoid hypertrophy (A/N ratio> 0.5 in lateral radiography of the nasopharynx). 5. Informed consent given by the patients and their guardians. Exclusion Criteria: Cleft palate or other systemic disorders. Patients are diagnosed with other nose, sinuses or ear diseases that are eligible for surgical treatment. Patients are diagnosed with OSAHS, tonsil hypertrophy ≥II° or scheduled for tonsillectomy. History of tympanostomy tube placement. Infection of the upper respiratory tract or acute rhinosinusitis over the past 7 days. Sensorineural hearing loss. Other situations that the investigators find unsuitable for the trial.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TT<br>Participants only receive tympanostomy tube placement. | Procedure: tympanostomy tube placement<br>* An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.<br>|
| Experimental: Ad+TT<br>Participants will receive tympanostomy tube placement and concurrent adenoidectomy. | Procedure: tympanostomy tube placement<br>* An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.<br>Procedure: adenoidectomy<br>* The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Otitis media with effusion, tympanostomy tube placement, adjuvant adenoidectomy, hearing outcome