Otitis Media With Effusion in Children
Conditions
Keywords
Otitis media with effusion, tympanostomy tube placement, adjuvant adenoidectomy, hearing outcome
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.
Interventions
PROCEDUREtympanostomy tube placement
An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.
PROCEDUREadenoidectomy
The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Children's Hospital of Fudan University
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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
1. Cleft palate or other systemic disorders. 2. Patients are diagnosed with other nose, sinuses or ear diseases that are eligible for surgical treatment. 3. Patients are diagnosed with OSAHS, tonsil hypertrophy ≥II° or scheduled for tonsillectomy. 4. History of tympanostomy tube placement. 5. Infection of the upper respiratory tract or acute rhinosinusitis over the past 7 days. 6. Sensorineural hearing loss. 7. Other situations that the investigators find unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | 1 year after tube removal | Rate of OME recurrence |
| Rate of repeated tube placement | 1 year after tube removal | proportion of patients who need repeated tube insertion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pure tone audiometry | 2 years after tube insertion | Change of pure tone audiometry thresholds compared with baseline |
| Otitis Media-6 and Pediatric Sleep Questionnaire | 2 years after tube insertion | 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. |
| AOM attacks | 1 year after tube removal | The number of acute otitis media attacks |
| Costs of OME-related visits and treatment | Through study completion, an average of 2 years | Medical expenses associated with OME |
| Complications | 2 years after tube insertion | Complications related to interventions of this study |
| Otorrhea | 2 years after tube insertion | Rate of Otorrhea |
Contacts
Primary ContactHuiqian Yu, PhD
Backup ContactFangzhou Yu, MD
Outcome results
None listed