NCT05545345

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

August 4, 2022

Last Update Submit

September 16, 2022

Conditions

Otitis Media With Effusion in Children

Keywords

Otitis media with effusiontympanostomy tube placementadjuvant adenoidectomyhearing outcome

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • AOM attacks

    1 year after tube removal

  • Otorrhea

    2 years after tube insertion

  • Pure tone audiometry

    2 years after tube insertion

  • Otitis Media-6 and Pediatric Sleep Questionnaire

    2 years after tube insertion

  • Complications

    2 years after tube insertion

  • +1 more secondary outcomes

Study Arms (2)

TT

ACTIVE COMPARATOR

Participants only receive tympanostomy tube placement.

Procedure: tympanostomy tube placement

Ad+TT

EXPERIMENTAL

Participants will receive tympanostomy tube placement and concurrent adenoidectomy.

Procedure: tympanostomy tube placementProcedure: adenoidectomy

Interventions

tympanostomy tube placementPROCEDURE

An incision will be made in the the tympanic membrane, through which a ventilation tube will be inserted.

Ad+TTTT
adenoidectomyPROCEDURE

The adenoid is resected transorally under a 70° endoscope with microdebrider or coblator until torus tubarius and choanae are completely revealed.

Ad+TT

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. Children 4-12 years of age.
  • \. 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;
  • \. Documented hearing loss ≥20dB (average threshold of 500Hz, 1000Hz and 2kHz in pure tone audiometry).
  • \. Adenoid hypertrophy (A/N ratio\> 0.5 in lateral radiography of the nasopharynx).
  • \. Informed consent given by the patients and their guardians.

You may not qualify if:

  • Cleft palate or other systemic disorders.
  • Patients are diagnosed with other nose, sinuses or ear diseases that are eligible for surgical treatment.
  • Patients are diagnosed with OSAHS, tonsil hypertrophy ≥II° or scheduled for tonsillectomy.
  • History of tympanostomy tube placement.
  • Infection of the upper respiratory tract or acute rhinosinusitis over the past 7 days.
  • Sensorineural hearing loss.
  • Other situations that the investigators find unsuitable for the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Adenoidectomy

Condition Hierarchy (Ancestors)

Otitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Huiqian Yu, PhD

CONTACT

86-13636423139yhq925@163.com

Fangzhou Yu, MD

CONTACT

86-1832171973213301050317@fudan.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2022

First Posted

September 19, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

September 19, 2022

Record last verified: 2022-09