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Trial registered on ANZCTR


Registration number
ACTRN12611001073998
Ethics application status
Approved
Date submitted
12/10/2011
Date registered
17/10/2011
Date last updated
3/02/2020
Date data sharing statement initially provided
3/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Surgery for otitis media in Indigenous Australian children
Scientific title
A 12 month, multi-centred, randomized trial to compare the outcomes of two surgical and one medical intervention on chronic Otitis Media in Indigenous children living in remote communities of Australia.

Medicine V surgery sub-study
Secondary ID [1] 273203 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
OM medicine V surgery sub-study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Otitis Media 278960 0
Condition category
Condition code
Ear 279139 279139 0 0
Other ear disorders
Surgery 279140 279140 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a multi-centre randomised (allocation concealed) trial of the effects of two surgical interventions in the management of Otitis Media with effusion (OME) / recurrent Acute Otitis Media (rAOM) with the primary outcome determined by a blinded assessor.

Aboriginal and Torres Strait Islander children, and non-Indigenous children from the same communities, between the ages of 3-10 years of age will be randomized into 3 groups according to age, sex, and desert or tropical dweller:
1. adenoidectomy with ventilation tubes (VTA)
2. adenoidectomy with myringotomy (MA)
3. medical treatment as clinically indicated

All 3 treatments are currently acceptable for this condition. The study will test whether there is an advantage of VTA or MA over medical therapy in controlling OME/rAOM.

Only children who have been referred to ENT clinics for treatment of chronic OM will be eligible for recruitment. The children will be treated using one of these 3 interventions whether they participate in the trial or not. The difference will be the choice of treatment by the surgeon (non-participants) or by computer allocation (participants).

The surgical interventions may take up to 30 minutes per child. The surgery will occur once per child only. Children allocated to the medical intervention may be given surgical treatment after 12 months if deemed necessary by the ENT specialist.

TREATMENT PROTOCOLS
Adenoidectomy will be performed under direct vision utilizing a suction diathermy or curette technique followed by five days of the oral antibiotic, amoxycillin (or cotrimoxazole if allergic to penicillin) to reduce the risk of postoperative infection, bleeding and halitosis. Adenoidal tissue will be biopsied for culture and histopathological analysis.

Ventilation tube insertion will be of a standardized tube (Shephard’s) in the anterior inferior segment of the tympanic membrane after aspiration of the middle ear fluid. All children having ventilation tubes will be prescribed post-operative Ciprofloxacin ear drops (Ciloxan / registered trademark) with three drops three times a day for three days to reduce post operative otorrhoea and blockage of the tube.

Myringotomy alone will be a small radial incision to the anterior inferior segment of the tympanic membrane with suction of middle ear fluid.

The parents/carers will be counselled to seek medical attention if there are signs of secondary haemorrhage from the adenoid region. Paracetamol or similar analgesia (rather than non-steroidal medications) will be prescribed post operatively.

Children allocated to the medical control arm will have already failed “standard medical care”. These children will receive additional specialist attention. This will include advice (written and verbal information with an interpreter if required) about the management of hearing and effective communication strategies and further antibiotic treatment (if appropriate). Referral to audiological services will ensure that children with more significant conductive hearing loss receive appropriate hearing support in the 12 months after randomisation.

All children will be followed up with monthly phone calls to the Community Health Worker who will determine and report the presence or absence of aural discharge.
All children will be followed up by the study staff visiting them in the community for full audiometric / tympanometry / video-otoscopy assessment at 12 months post op.
Intervention code [1] 269536 0
Treatment: Surgery
Comparator / control treatment
Medical treatment will be determined after randomisation at the discretion of the ENT surgeon. It will comprise antibiotic therapy and monthly review (by phone call to local health worker).
All children in the trial will be followed up 12 months post intervention.
For those in the medical group surgery may still be required at the discretion of the treating ENT specialist at that time.
Control group
Active

Outcomes
Primary outcome [1] 279785 0
a reduction in the prevalence of Otitis Media with effusion (OME) / recurrent Acute Otitis Media (rAOM)
Timepoint [1] 279785 0
Audiometry, tympanometry, video-otoscopy data will be collected at randomisation and 12 months later to determine improvement in total ear health.
Secondary outcome [1] 294423 0
reduction of hearing impairment,
Timepoint [1] 294423 0
Audiometry & tympanometry at randomisation and 12 months post intervention.

An improvement in the rate of hearing loss is defined as an improvement of 10 dB or more, over, at least two frequencies.
The study will provide estimates of the rate of hearing loss in each group.
Secondary outcome [2] 294424 0
reduction of aural discharge,
Timepoint [2] 294424 0
Aural & nasal swabs will be collected at randomisation & 12 months from all participants.
Adenoid tissue & middle ear fluid (if present) will be collected from those in the 2 surgical groups during surgery.

Monthly review of the presence of aural discharge will be reported by the Community Health Worker.

Standard methods will be used for culturing, quantification of bacterial load and sensitivity testing of respiratory pathogens (Steptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis).

For ear discharge specimens, we will also use standard methods for identifying common chronic suppurative otitis media pathogens. The analysis of microbiological outcomes will be descriptive.

We will determine the effect of adenoidectomy on nasopharyngeal bacterial carriage, by quantitative assessment through colony counts and real-time quantitative PCR21 and culture of the main pathological bacteria (Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrahlis) before and after the proposed interventions.
Secondary outcome [3] 294425 0
reduction of aural perforation,
Timepoint [3] 294425 0
Video-otoscopy with photographs at randomisation and 12 months.
Secondary outcome [4] 294426 0
review of effect of treatment on nasal colonisation with pathogenic bacteria.
Timepoint [4] 294426 0
Culture & sensitivity of aural & nasal swabs at randomisation & 12 months.

Bacterial load estimates of nose swabs will be used to determine whether this measure is able to predict which children are most likely to develop ear discharge and whether adenoidectomy reduces bacterial load in the nasopharynx of Aboriginal children.
Secondary outcome [5] 300834 0
To measure systemic and mucosal antibody responses (including IgA, IgG, IgG subclasses & IgE) and their functionality, to pneumococcal and NTHi surface antigens in serum, saliva and middle ear effusion in indigenous children undergoing surgical intervention for chronic OM.

Timepoint [5] 300834 0
Baseline:
- saliva samples from all participants
- serum samples from children in surgical groups (taken while under GA)

12 months:
- saliva samples from all participants

Eligibility
Key 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)
Minimum age
3 Years
Maximum age
10 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with conditions which may predispose to post-op complications eg: cleft palate, Downes syndrome, generalised immunolgical conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children will be allocated by IVRS system (based at Uni Sydney).
Sequence will be 2:1:1 (medical : VTA: MA)
That is, 1:1, medicine: surgery allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children referred for Ear, Nose and Throat assessment who have failed medical care for chronic otitis media will be eligible to participate in the study. Enrollment / Recruitment will not be considered until a child is found to be a surgical candidate in an ENT clinic.

Children will be randomly allocated to receive one of the 2 surgical interventions or the medical intervention, with equal allocation.

Allocation will be stratified by centre, region (tropical or desert), age (3-5, >5 y.o.).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Recruitment was foccused on the sub-trial surgery vs surgery only, decision made to not recruit for this trial.
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT,WA
Recruitment hospital [1] 480 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [2] 481 0
Gove District Hospital - Nhulunbuy
Recruitment hospital [3] 482 0
Katherine Hospital - Katherine
Recruitment hospital [4] 483 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [5] 484 0
Kalgoorlie Hospital - Kalgoorlie
Recruitment hospital [6] 485 0
Broome Hospital - Broome
Recruitment hospital [7] 486 0
Derby Hospital - Derby
Recruitment hospital [8] 487 0
Kununurra Hospital - Kununurra
Recruitment postcode(s) [1] 6228 0
0811 - Casuarina
Recruitment postcode(s) [2] 6229 0
0881 - Nhulunbuy
Recruitment postcode(s) [3] 6230 0
0852 - Katherine
Recruitment postcode(s) [4] 6231 0
0871 - Alice Springs
Recruitment postcode(s) [5] 6232 0
6433 - Kalgoorlie
Recruitment postcode(s) [6] 6233 0
6725 - Broome
Recruitment postcode(s) [7] 6234 0
6728 - Derby
Recruitment postcode(s) [8] 6235 0
6743 - Kununurra

Funding & Sponsors
Funding source category [1] 270029 0
Government body
Name [1] 270029 0
National Health & Medical Research Council (NHMRC)
Address [1] 270029 0
Research Investment Branch
National Health & Medical Research Council
16 Marcus Clarke Street,
Canberra City ACT 2600
Country [1] 270029 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne
Grattan St
Carlton
Vic 3010
Country
Australia
Secondary sponsor category [1] 269016 0
Hospital
Name [1] 269016 0
Royal Victorian Eye & Ear Hospital
Address [1] 269016 0
32 Gisborne St
East Melbourne
Victoria 3002
Country [1] 269016 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271985 0
Royal Victorian Eye & Ear Hospital HREC
Ethics committee address [1] 271985 0
32 Gisborne St
East Melbourne
Victoria 3002
Ethics committee country [1] 271985 0
Australia
Date submitted for ethics approval [1] 271985 0
Approval date [1] 271985 0
27/06/2011
Ethics approval number [1] 271985 0
11/1023H
Ethics committee name [2] 288697 0
Central Australia HREC
Ethics committee address [2] 288697 0
PO Box 4066
Alice Springs.
NT 0871
Ethics committee country [2] 288697 0
Australia
Date submitted for ethics approval [2] 288697 0
Approval date [2] 288697 0
03/04/2012
Ethics approval number [2] 288697 0
HOMER -12-16
Ethics committee name [3] 288698 0
Menzies School of Health Research HREC
Ethics committee address [3] 288698 0
Royal Darwin Hospital Campus
Rocklands Dve
Casuarina
NT 0810
Ethics committee country [3] 288698 0
Australia
Date submitted for ethics approval [3] 288698 0
Approval date [3] 288698 0
21/05/2012
Ethics approval number [3] 288698 0
2011-1686
Ethics committee name [4] 288699 0
WA CHS HREC
Ethics committee address [4] 288699 0
1st Floor, Bunbury Tower,
61 Victoria St,
Bunbury,
WA 6230
Ethics committee country [4] 288699 0
Australia
Date submitted for ethics approval [4] 288699 0
Approval date [4] 288699 0
23/07/2012
Ethics approval number [4] 288699 0
2012-07
Ethics committee name [5] 288700 0
WA Aboriginal Heath Information Ethics Committee
Ethics committee address [5] 288700 0
12 Napier Terrace
PO Box 1377
Broome
Western Australia, 6725
Ethics committee country [5] 288700 0
Australia
Date submitted for ethics approval [5] 288700 0
23/02/2012
Approval date [5] 288700 0
Ethics approval number [5] 288700 0
Ethics committee name [6] 288701 0
Cairns Hinterland HREC
Ethics committee address [6] 288701 0
PO Box 902
Cairns Qld 4870
Ethics committee country [6] 288701 0
Australia
Date submitted for ethics approval [6] 288701 0
15/04/2013
Approval date [6] 288701 0
Ethics approval number [6] 288701 0

Summary
Brief summary
Ear infection (otitis media) is a major problem amongst children living in remote Australian communities. Medical treatment often fails, and ear nose and throat surgeons are called upon to provide surgical care.

This clinical trial will provide surgeons with evidence so that they can recommend the best possible operation for children living in desert and tropical regions, most of whom are indigenous, to improve hearing and reduce the prevalence of ear infection and discharging ears.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 26 26 0 0

Contacts
Principal investigator
Name 33265 0
Prof Stephen O'Leary
Address 33265 0
Dept Otolaryngology
RVE&E Hospital
32 Gisborne St East Melbourne
Victoria 3002
Country 33265 0
Australia
Phone 33265 0
61 3 9929 8366
Fax 33265 0
Email 33265 0
sjoleary@unimelb.edu.au
Contact person for public queries
Name 16512 0
Ms Katie Davis
Address 16512 0
Dept of Otolaryngology RVE&E Level 5 Hospital 32 Gisborne St East Melbourne Victoria 3002
Country 16512 0
Australia
Phone 16512 0
61 3 9929 8384
Fax 16512 0
61 3 9929 1958
Email 16512 0
katie.davis@unimelb.edu.au
Contact person for scientific queries
Name 7440 0
Prof Professor Stephen O'Leary
Address 7440 0
Dept of Otolaryngology
RVE&E Hospital
32 Gisborne St
East Melbourne
Victoria 3002
Country 7440 0
Australia
Phone 7440 0
61 3 9929 8366
Fax 7440 0
61 3 9929 1958
Email 7440 0
sjoleary@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results