Clinical trial NCT05545345: Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children
Official title: Adjuvant Adenoidectomy Plus Tympanostomy Tube Placement for the Treatment of Chronic OME in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Otitis Media With Effusion in Children
Keywords: Otitis media with effusion
tympanostomy tube placement
adjuvant adenoidectomy
hearing outcome
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Children's Hospital of Fudan University
First posted: 2022-09-19
Enrollment: 380
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Recurrence rate
timeFrame: 1 year after tube removal
measure: Rate of repeated tube placement
timeFrame: 1 year after tube removal
Secondary outcomes:
measure: AOM attacks
timeFrame: 1 year after tube removal
measure: Otorrhea
timeFrame: 2 years after tube insertion
measure: Pure tone audiometry
timeFrame: 2 years after tube insertion
measure: Otitis Media-6 and Pediatric Sleep Questionnaire
timeFrame: 2 years after tube insertion
measure: Complications
timeFrame: 2 years after tube insertion
measure: Costs of OME-related visits and treatment
timeFrame: Through study completion, an average of 2 years
Other outcomes:
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