NCT05545345

Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Otitis Media With Effusion in Children

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-09-19
• Last updated: 2022-09-19