Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children

Otitis Media With Effusion in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05545345
• Other study ID #: 2022-AdOME
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2025

Study information

• Verified date: September 2022
• Source: Eye & ENT Hospital of Fudan University
• Contact: Huiqian Yu, PhD
• Phone: 86-13636423139
• Email: yhq925[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 380
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media with Effusion
• Otitis Media With Effusion in Children

Intervention

Procedure:
• tympanostomy tube placement
An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.
• adenoidectomy
The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University	Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate	Rate of OME recurrence	1 year after tube removal
Primary	Rate of repeated tube placement	proportion of patients who need repeated tube insertion	1 year after tube removal
Secondary	AOM attacks	The number of acute otitis media attacks	1 year after tube removal
Secondary	Otorrhea	Rate of Otorrhea	2 years after tube insertion
Secondary	Pure tone audiometry	Change of pure tone audiometry thresholds compared with baseline	2 years after tube insertion
Secondary	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
Secondary	Complications	Complications related to interventions of this study	2 years after tube insertion
Secondary	Costs of OME-related visits and treatment	Medical expenses associated with OME	Through study completion, an average of 2 years