Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children

Not Applicable

Not yet recruiting

• Conditions: Otitis Media With Effusion in Children
• Interventions: Procedure: tympanostomy tube placement; Procedure: adenoidectomy

• Registration Number: NCT05545345
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2022-08-04
• Status Verified: 2022-09
• Study Start: 2022-09
• Study First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-16
• Study First Posted: 2022-09-19
• Last Update Posted: 2022-09-19
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 380

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TT	tympanostomy tube placement	Participants only receive tympanostomy tube placement.
Ad+TT	tympanostomy tube placement	Participants will receive tympanostomy tube placement and concurrent adenoidectomy.
Ad+TT	adenoidectomy	Participants will receive tympanostomy tube placement and concurrent adenoidectomy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
AOM attacks	1 year after tube removal	The number of acute otitis media attacks
Otorrhea	2 years after tube insertion	Rate of Otorrhea
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.
Complications	2 years after tube insertion	Complications related to interventions of this study
Costs of OME-related visits and treatment	Through study completion, an average of 2 years	Medical expenses associated with OME