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Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children

NCT05545345 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2022-09-19

No results posted yet for this study

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.

Conditions

  • Otitis Media With Effusion in Children

Interventions

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.

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Children's Hospital of Fudan University

    collaborator OTHER

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2025-09-30
Completion
2025-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05545345 on ClinicalTrials.gov