Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000102774
Ethics application status
Approved
Date submitted
23/01/2013
Date registered
25/01/2013
Date last updated
16/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Surgery for the treatment of Otitis Media in Indigenous children, surgical sub-study
Scientific title
This 12 month,surgical sub-study is a multi-centred, randomized trial to compare the outcomes of two surgical interventions on chronic Otitis Media in Indigenous children living in remote communities of Australia
Secondary ID [1] 281786 0
nil known
Universal Trial Number (UTN)
nil known
Trial acronym
OM, surgical sub-study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
otitis media 288108 0
myringotomy with adenoidectomy 288109 0
bilateral grommet tube insertion with adenoidectomy 288110 0
Condition category
Condition code
Ear 288484 288484 0 0
Deafness
Ear 288485 288485 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of outcomes of 2 surgical techniques in Indigenous children with OM living in remote communities.

Arm 1: bilateral myringotomy with adenoidectomy
Arm 2: bilateral grommet tube insertion and adenoidectomy

Both surgical interventions are performed once only under general anaesthetic according to standard, current surgical protocols and each routinely take less than 30 minutes. Surgery is performed by ENT specialists. There is nothing novel involved with these procedures. The study objective is to compare the outcomes of current interventions after 12 months.
The target group is the same as the original study, ie Indigenous children aged 3-10 yrs who have chronic otitis media.
The reason for the change was that North Queensland paediatricians believe that by the time surgery is recommended in Qld, the children have already undergone a supervised period of medical treatment to a degree not seen elsewhere in the country. However, there was an interest in Qld in addressing the surgical questions raised in this Trial.

The redesigned project has been divided into 2 parts,
1. Surgery V surgery substudy – 280 children across NT / WA and North Qld.
2. Surgery v medical care substudy – 200 children in NT & WA only
The total number of children (480) remains the same as originally proposed.
The total number of children whose data will be analysed to compare the 2 surgeries is therefore 380.
This comprises 280 from surgical sub-study and 100 from the surgical arm of the medical / surgical sub-study.
The data from both studies will be entered into a common database.
Intervention code [1] 286329 0
Treatment: Surgery
Comparator / control treatment
ANZCTR trial number 12611001073998 was submitted as a Medical V surgical comparison of 2 surgical interventions against a medical arm as control (1:1:1). It will retain the same 3 treatment arms however the allocation ratios have changed. The original study required 480 children.

The 2 studies will run concurrently over 3 years with the medical sub-study starting later in 2013.

Revised Study: medical V surgery:
200 children in NT & WA (not Qld)
Randomised at time of consent in community to medical or surgical group (1:1)
The 100 Medical arm children will not be sent to hospital but will be reviewed in community for 12 months
The 100 Surgical arm children will be re-randomised to either VTA or MA (1:1) at the time of surgery

Study: Surgery V surgery:
280 children across NT, WA & N Qld
to receive either grommets & adenoidectomy(VTA) or myringotomy & adenoidectomy (MA)
There is no medical arm in this substudy.


The data from this surgical substudy will be analysed together with the surgical data from the concurrent surgical arms in the medical study. This will be a comparison of the outcomes of 2 surgical interventions.
The surgical data will then compared with the medical V surgical sub-study data using the medical arm as a comparator.

The statistician has advised that having children in the following ratios (VTA 190 : MA 190 : Medical 100) is adequate for the power calculations.
Control group
Active

Outcomes
Primary outcome [1] 288643 0
Primary outcome is expected to be a reduction in the presence of bilateral OME at 12 months by 50% in the MA group.

Clinical assessments at baseline & 12 months:

video-otoscopy
nasal & saliva swabs
ear discharge swabs

baseline on surgical participants only:
serum samples collected while under GA.
adenoid tissue
Timepoint [1] 288643 0
Baseline & 12 months
Secondary outcome [1] 300685 0
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).
Assessment by:
audiometry,
tympanometry,
Timepoint [1] 300685 0
baseline & 12 months
Secondary outcome [2] 300686 0
Reduction in aural discharge in myringotomy arm compared to VTA arm.

Monthly phone calls to families, community health centres to record any incidence of ear discharge in preceding 4 weeks.
Timepoint [2] 300686 0
At 12 months the data will be determined as
Absent - no incidence
Infrequent (<3 in 12 months and none during 12 m assessment)
Recurrent - (>3 episodes or persistent or present at 12m assessment)

Eligibility
Key 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.
Minimum age
3 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children referred for Ear, Nose and Throat assessment who have failed medical care for their otitis media will be eligible to participate in the study. Recruitment will not be considered until a child is found to be a surgical candidate in an ENT clinic or as advised by an ENT surgeon.

Randomisation will occur after a decision has been made that surgery is indicated as close to surgery as feasible. Data must be available showing audiometry testing within the previous 6 months.

Children will be allocated via a central randomisation service (IVRS system) provided by NHMRC Clinical Trials Centre. The random allocation sequence will be determined by minimisation. The allocation sequence will be concealed from the investigators and research staff at all times.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation: .
Children will be randomly allocated to receive either surgical intervention (1;1). Allocation will be stratified by hospital site and age (3-5, >5 y.o.).

Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
Recurrence of bilateral OME
For an overall significance level of 5% to be maintained, each predefined comparison would be compared at the 2.5% significance level. These comparisons are as above.
1) The sample size of 190 per arm would have more than 90% power to detect a reduction of 17%, from an average recurrence rate of 27% in the Ventilation tubes and adenoidectomy arm to 10% recurrence in Myringotomy and adenoidectomy. This power is assumes a 20% loss to follow-up.
The study will provide estimates of the rate of recurrence of OME in each group.

These figures include the surgical cases in the combined study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/05/2014
Actual
11/05/2014
Date of last participant enrolment
Anticipated
15/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
71
Final
Recruitment in Australia
Recruitment state(s)
NT,QLD,WA
Recruitment hospital [1] 419 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [2] 420 0
Cairns Base Hospital - Cairns
Recruitment hospital [3] 421 0
Kalgoorlie Hospital - Kalgoorlie
Recruitment hospital [4] 423 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [5] 5204 0
Katherine Hospital - Katherine
Recruitment hospital [6] 5205 0
Weipa Hospital - Weipa
Recruitment hospital [7] 5206 0
Cooktown Hospital - Cooktown
Recruitment hospital [8] 5207 0
Gove District Hospital - Nhulunbuy
Recruitment postcode(s) [1] 6180 0
0811 - Casuarina
Recruitment postcode(s) [2] 6181 0
4870 - Cairns
Recruitment postcode(s) [3] 6182 0
6430 - Kalgoorlie
Recruitment postcode(s) [4] 6184 0
0870 - Alice Springs
Recruitment postcode(s) [5] 12673 0
0850 - Katherine
Recruitment postcode(s) [6] 12674 0
4874 - Weipa
Recruitment postcode(s) [7] 12675 0
4895 - Cooktown
Recruitment postcode(s) [8] 12676 0
0880 - Nhulunbuy

Funding & Sponsors
Funding source category [1] 286571 0
Government body
Name [1] 286571 0
NHMRC
Grant number 1007641
Country [1] 286571 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Melbourne Research
Level 5, 161 Barry Street
The University of Melbourne
Parkville 3010 VIC
Country
Australia
Secondary sponsor category [1] 285355 0
None
Name [1] 285355 0
Address [1] 285355 0
Country [1] 285355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288636 0
Royal Victorian Eye & Ear Hospital (RVE&E)
Ethics committee address [1] 288636 0
Ethics committee country [1] 288636 0
Australia
Date submitted for ethics approval [1] 288636 0
Approval date [1] 288636 0
27/06/2011
Ethics approval number [1] 288636 0
11/1023H
Ethics committee name [2] 288637 0
Menzies School of Health Research HREC
Ethics committee address [2] 288637 0
Ethics committee country [2] 288637 0
Australia
Date submitted for ethics approval [2] 288637 0
Approval date [2] 288637 0
27/06/2011
Ethics approval number [2] 288637 0
2011-1686
Ethics committee name [3] 288638 0
Central Australia HREC
Ethics committee address [3] 288638 0
Ethics committee country [3] 288638 0
Date submitted for ethics approval [3] 288638 0
Approval date [3] 288638 0
27/06/2011
Ethics approval number [3] 288638 0
HOMER 12-16
Ethics committee name [4] 288640 0
WA CHS HREC
Ethics committee address [4] 288640 0
Ethics committee country [4] 288640 0
Australia
Date submitted for ethics approval [4] 288640 0
Approval date [4] 288640 0
27/06/2011
Ethics approval number [4] 288640 0
2012:07
Ethics committee name [5] 288641 0
Cairns & Hinterland Health Service District Ethics Committee
Ethics committee address [5] 288641 0
Ethics committee country [5] 288641 0
Australia
Date submitted for ethics approval [5] 288641 0
22/04/2013
Approval date [5] 288641 0
11/09/2013
Ethics approval number [5] 288641 0
WA Aboriginal Health Information Ethics Committee
Ethics committee name [6] 288642 0
WA Aboriginal Heath Information Ethics Committee
Ethics committee address [6] 288642 0
Ethics committee country [6] 288642 0
Australia
Date submitted for ethics approval [6] 288642 0
01/02/2012
Approval date [6] 288642 0
21/10/2013
Ethics approval number [6] 288642 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37090 0
Prof Stephen O'Leary
Address 37090 0
RVE&E Hospital
level 2
32 Gisborne St
East Melbourne
Victoria 3002
Country 37090 0
Australia
Phone 37090 0
61 3 9929 8366
Fax 37090 0
Email 37090 0
sjoleary@unimelb.edu.au
Contact person for public queries
Name 37091 0
Katie Davis
Address 37091 0
RVE&E Hospital level 5 32 Gisborne St East Melbourne Victoria 3002
Country 37091 0
Australia
Phone 37091 0
+61 3 9929 8293
Fax 37091 0
Email 37091 0
katie.davis@unimelb.edu.au
Contact person for scientific queries
Name 37092 0
Stephen O'Leary
Address 37092 0
RVE&E Hospital
level 2
32 Gisborne St
East Melbourne
Victoria 3002
Country 37092 0
Australia
Phone 37092 0
61 3 9929 8366
Fax 37092 0
Email 37092 0
sjoleary@unimelb.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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