Surgery for otitis media in Indigenous Australian childre

Phase 4

Withdrawn

• Conditions: Chronic Otitis Media; Ear - Other ear disorders; Surgery - Surgical techniques

• Registration Number: ACTRN12611001073998
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-17
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Indigenous & non-indigenous children aged 3-10 years living in remote Australian communities.

Otitis Media with effusion / recurrent Acute Otitis Media (OME /rAOM) for greater than 3 months and failed medical treatment.

Glue ear (immovable tympanic membrane) determined by tympanometry & otoscopy

Mild or moderate conductive hearing impairment (>15dB in soundproof room or >25db in non-sound proof)

Exclusion Criteria

Children with conditions which may predispose to post-op complications eg: cleft palate, Downes syndrome, generalised immunolgical conditions

Study & Design

• Study Type: Interventional
• Study Design: Not specified