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Trial registered on ANZCTR
Registration number
ACTRN12624000651583
Ethics application status
Approved
Date submitted
2/04/2024
Date registered
21/05/2024
Date last updated
21/05/2024
Date data sharing statement initially provided
21/05/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparing outcomes between the use of autologous fascia lata graft versus synthetic polypropylene mesh for sacrocolpopexy in the treatment of apical vaginal prolapse
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Scientific title
Comparing outcomes between the use of autologous fascia lata graft versus synthetic polypropylene mesh for sacrocolpopexy in the treatment of apical vaginal prolapse.
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Secondary ID [1]
311876
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pelvic organ prolapse
333434
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Recurrent pelvic organ prolapse
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Condition category
Condition code
Renal and Urogenital
330107
330107
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0
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Other renal and urogenital disorders
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Reproductive Health and Childbirth
330108
330108
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0
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Other reproductive health and childbirth disorders
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Surgery
330404
330404
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Sacrocolpopexy (laparoscopic or open) - a surgical procedure using a graft material either autologous (harvested fascia lata from that patient's lateral thigh) or synthetic polypropylene mesh (TiLoop Mesh) to attach the vaginal vault to the sacral promontory in order to treat vault prolapse
Participating patients are offered sacrocolpopexy for vault prolapse as a treatment option as per the Australian Guideline - if they chose this option they are offered both fascia lata graft or synthetic polypropylene mesh. This counselling is conducted by Urogynaecology subspecialists. The patient can then select either option, there is no randominisation.
Duration of intervention - duration of surgery is between 2-4hours. Duration of expected hospital stay is between 2-4 days. Post operative review in clinic will occur at 6-8 weeks, 6 months, then yearly up to 5 years post surgery, more often if there is clinical need.
All cases included will have data collection by an independent research fellow to ensure counselling, consent, surgery and outcomes align with the study protocol.
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Intervention code [1]
328336
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Treatment: Surgery
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Intervention code [2]
328337
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Treatment: Devices
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Comparator / control treatment
Comparator:
Group 1: Sacrocolpopexy procedure using synthetic polypropylene mesh (reference comparator)
Group 2: Sacrocolpopexy procedure using autologous fascia lata (harvested fascia lata from that patient's lateral thigh compartment)
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Control group
Active
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Outcomes
Primary outcome [1]
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Composite outcome of “success” defined as the absence of:
1. Descent of apex more than 1/3 of vaginal canal
2. Anterior or posterior descent beyond hymen
3. bothersome vaginal bulge symptoms
4. retreatment for Pelvic organ prolapse (POP) with pessary and/or surgery
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Assessment method [1]
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Clinical - patient history and examination. Information will be collected by medical practitioners at scheduled patient visits. Examination will be completed by a Urogynaecologist or Urogynaecology Accredited Trainee. The information will be recorded in the patient's electronic record and then data will be collated by the research fellow and team.
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Timepoint [1]
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Assessed at 6 weeks, 6 months, then yearly for 5 years (post-surgery - primary timepoint)
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Secondary outcome [1]
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Objective recurrence of prolapse (clinical and on transperineal US)
Sonographic recurrent definition: Bladder measured at >=10mm below the symphysis pubis (SP), vault at >=0mm below the SP, rectal ampulla at >=15mm below the symphysis pubis
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Assessment method [1]
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Transperineal ultrasound
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Timepoint [1]
433525
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Assessed at 6 weeks, 6 months, then yearly for 5 years
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Secondary outcome [2]
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Subjective symptoms of prolapse as identified on standardised interview as a composite outcome
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Assessment method [2]
433526
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Clinical interview (one-on-one - however patient support person may be present, face to face) by practitioner
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Timepoint [2]
433526
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Assessed at 6 weeks, 6 months, then yearly for 5 years
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Secondary outcome [3]
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Subjective symptoms of prolapse on validated questionnaire - Australian Pelvic Floor Questionnaire (APFQ)
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Assessment method [3]
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Australian Pelvic Floor Questionnaire (APFQ)
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Timepoint [3]
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Assessed at 6 weeks, 6 months, then yearly for 5 years
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Secondary outcome [4]
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Graft or mesh related complications – pain, dyspareunia, mesh erosion or exposure, new pathological urinary or bowel function, requirement for re-operation either for graft/mesh-related complication or for recurrence of prolapse (composite outcome)
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Assessment method [4]
433528
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Clinical interview (one-on-one - however patient support person may be present, face to face) by practitioner
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Timepoint [4]
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Assessed at 6 weeks, 6 months, then yearly for 5 years
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Secondary outcome [5]
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Subjective symptoms of prolapse on validated questionnaire - The Short Assessment of Patient Satisfaction (SAPS)
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Assessment method [5]
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The Short Assessment of Patient Satisfaction (SAPS)
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Timepoint [5]
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Assessed at 6 weeks, 6 months, then yearly for 5 years
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Eligibility
Key inclusion criteria
Patients assessed by subspecialist Urogynaecologist (Certificate of Urogynaecology - RANZCOG) who are candidates for sacrocolpopexy treatment for apical vaginal prolapse
- Care at one of the three sites: Varsity Lakes/Robina Hospital, Pindara Private Hospital or Greenslopes Private Hospital
- Who have their care between 1st April 2023 – 1st April 2028
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Those not appropriate for sacrocolpopexy surgery
Those unable to understand the study and/or provide informed consent
Those having care at sites not listed for the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Plan to analyse the data using SPSS to perform preliminary/ basic statistical analysis for significance of difference between cohort. A two-sample t-test will be performed on continuous variables and chi-square analysis for categorical variables. P<0.05 will be considered as statistically significant.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
15/09/2023
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Date of last participant enrolment
Anticipated
15/09/2028
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Actual
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Date of last data collection
Anticipated
15/09/2033
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Actual
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Sample size
Target
60
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Accrual to date
8
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Robina Hospital - Robina
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Recruitment hospital [2]
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Greenslopes Private Hospital - Greenslopes
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Recruitment hospital [3]
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Pindara Private Hospital - Benowa
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Recruitment postcode(s) [1]
42322
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4226 - Robina
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Recruitment postcode(s) [2]
42323
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4120 - Greenslopes
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Recruitment postcode(s) [3]
42324
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4217 - Benowa
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Gold Coast Health
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Address [1]
316221
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
Gold Coast Health
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Address
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Urogynaecologist - Gold Coast Health
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Address [1]
318404
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Country [1]
318404
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315036
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Gold Coast Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
315036
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https://www.goldcoast.health.qld.gov.au/research/researchers/ethics/human-research-ethics-committee
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Ethics committee country [1]
315036
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Australia
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Date submitted for ethics approval [1]
315036
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15/03/2023
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Approval date [1]
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18/06/2023
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Ethics approval number [1]
315036
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HREC/2023/QGC/95494
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Summary
Brief summary
A study to investigate the differences in subjective, objective and quality of life outcomes between sacral colpopexy with mesh (Type 1 polypropylene) versus alternative graft (autologous fascia lata) at 6, 12, 24 month and 5 years
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Vivien Wong
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Address
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Urogynaecology Unit, Varsity Lakes Day Hospital, Level 1, 2 Lake Street, Varsity Lakes 2447
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Country
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Australia
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Phone
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+61 07 56190650
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Fax
133498
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Email
133498
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[email protected]
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Contact person for public queries
Name
133499
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A/Prof Vivien Wong
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Address
133499
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Urogynaecology Unit, Varsity Lakes Day Hospital, Level 1, 2 Lake Street, Varsity Lakes 2447
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Country
133499
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Australia
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Phone
133499
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+61 07 56190650
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Fax
133499
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Email
133499
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Vivien Wong
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Address
133500
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Urogynaecology Unit, Varsity Lakes Day Hospital, Level 1, 2 Lake Street, Varsity Lakes 2447
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Country
133500
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Australia
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Phone
133500
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+61 07 56190650
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Fax
133500
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Email
133500
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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