Surgery for the treatment of Otitis Media in Indigenous children, surgical sub-study

Not Applicable

Recruiting

• Conditions: otitis media; myringotomy with adenoidectomy; bilateral grommet tube insertion with adenoidectomy; Ear - Deafness; Ear - Other ear disorders

• Registration Number: ACTRN12613000102774
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Indigenous children aged 3 - 10 years old living in remote communities

- OME/AOM that has been present for greater than or equal to 6 months and failed medical treatment. The criteria for the diagnosis of glue ear will be the presence of an immobile tympanic membrane on pneumatic otoscopy, supported by an air-bone gap on audiometry and a Type B tympanogram.

- A mild or moderate conductive hearing impairment, defined as a pure-tone average of greater than or equal to 20 dB when tested in a sound-proofed room, or greater than 30dB when tested in non sound-proofed conditions.
Approximately 70% of children with OME/AOM are expected to meet this criterion.

Exclusion Criteria

Children with any of the following conditions which may predispose to complications following adenoidectomy:
Cleft palate
Submucous cleft palate
Down Syndrome
Cranio-facial syndromes
Generalised immunological diseases
Bleeding diasthesis
Requirement for concomitant tonsillectomy
Also exclude Children requiring treatment of unilateral ear pathology

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is expected to be a reduction in the presence of bilateral OME at 12 months by 50% in the MA group. <br><br>Clinical assessments at baseline & 12 months: <br><br>video-otoscopy<br>nasal & saliva swabs<br>ear discharge swabs<br><br>baseline on surgical participants only: <br>serum samples collected while under GA.<br>adenoid tissue<br><br>[ Baseline & 12 months]

Secondary Outcome Measures

Name	Time	Method
An improvement in the rate of hearing loss is defined as an improvement of 10 dB or more in the pure tone average hearing loss (PTA). <br>Assessment by:<br>audiometry, <br>tympanometry, [baseline & 12 months];Reduction in aural discharge in myringotomy arm compared to VTA arm.<br><br>Monthly phone calls to families, community health centres to record any incidence of ear discharge in preceding 4 weeks.[At 12 months the data will be determined as<br>Absent - no incidence<br>Infrequent (<3 in 12 months and none during 12 m assessment)<br>Recurrent - (>3 episodes or persistent or present at 12m assessment)]