Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Otitis Media With Effusion in Children
• Intervention / Treatment: Procedure: tympanostomy tube placement; Procedure: 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 Type: Interventional
• Enrollment (Anticipated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huiqian Yu, PhD; Phone Number: 86-13636423139; Email: yhq925@163.com
• Study Contact Backup: Name: Fangzhou Yu, MD; Phone Number: 86-18321719732; Email: 13301050317@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Collaborators: Children's Hospital of Fudan University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Otitis media with effusion; tympanostomy tube placement; adjuvant adenoidectomy; hearing outcome
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Otitis Media with Effusion
• Other Study ID Numbers: 2022-AdOME

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No