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Trial registered on ANZCTR
Registration number
ACTRN12615000125527
Ethics application status
Approved
Date submitted
28/01/2015
Date registered
11/02/2015
Date last updated
14/07/2024
Date data sharing statement initially provided
20/11/2019
Date results provided
3/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
PreRELIEF - The haemodynamic consequence of restriction compared to liberal intravenous fluid therapy in patients undergoing major abdominal surgery.
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Scientific title
The difference in the haemodynamics, including difference in stroke volume or preload responsiveness in patients randomised to the restrictive or liberal intravenous fluid therapy in major abdominal surgery.
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Secondary ID [1]
285457
0
Nil Known
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Universal Trial Number (UTN)
U1111-1162-6968
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Trial acronym
PreRELIEF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Abdominal Surgery
293273
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Fluid therapy intraoperative
293274
0
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Haemodynamics, specifically stroke volume and preload responsiveness
293275
0
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Condition category
Condition code
Anaesthesiology
293541
293541
0
0
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Other anaesthesiology
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Cardiovascular
294424
294424
0
0
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Normal development and function of the cardiovascular system
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Restrictive fluid therapy a) intraoperative protocol of intravenous infusion: induction of anaesthesia Hartmann's solution <5mls/kg bolus, intraop maintenance rate 5mls/kg/hr, bolus colloid/blood to replace blood loss (ml for ml). b) postoperative protocol of intravenous infusion Hartmann's 0.8mls/kg/hr for 24hrs.
Haemodynamic variables to be assessed i. Doppler stroke volume, cardiac index, corrected flow time ii. pulse contour analysis stroke volume, cardiac index, pulse pressure variation iii. plethysmographic variability index, perfusion index. These variables will be assessed at the beginning of surgery and at the end of surgery with a passive leg raise manouvre.
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Intervention code [1]
291050
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Not applicable
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Comparator / control treatment
Liberal fluid therapy a) intraoperative protocol of intravenous infusion: induction of anaesthesia Hartmann's solution 10mls/kg bolus, intraop maintenance rate 8mls/kg/hr, treat hypotension and hypovolemia with fluid boluses of colloid or crystalloid. b) postoperative protocol of intravenous infusion of Hartmann's solution 1.5mls/kg/hr for 24hrs.
Haemodynamic variables to be assessed i. Doppler stroke volume, cardiac index, corrected flow time ii. pulse contour analysis stroke volume, cardiac index, pulse pressure variation iii. plethysmographic variability index, perfusion index. These variables will be assessed at the beginning of surgery and at the end of surgery with a passive leg raise manouvre.
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Control group
Active
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Outcomes
Primary outcome [1]
293363
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Difference in doppler derived stroke volume at the end of surgery between the Restrictive and Liberal groups.
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Assessment method [1]
293363
0
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Timepoint [1]
293363
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End of surgery
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Secondary outcome [1]
310854
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Doppler derived corrected flow time
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Assessment method [1]
310854
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Timepoint [1]
310854
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end of surgery
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Secondary outcome [2]
310855
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Pulse contour analysis Stroke volume index
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Assessment method [2]
310855
0
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Timepoint [2]
310855
0
end of surgery
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Secondary outcome [3]
310856
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Pulse contour analysis Pulse Pressure Variation
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Assessment method [3]
310856
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Timepoint [3]
310856
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End of surgery
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Secondary outcome [4]
312820
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Plethysmographic variability Index
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Assessment method [4]
312820
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Timepoint [4]
312820
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End of surgery
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Secondary outcome [5]
312821
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Proportion of patients who are fluid responsive.
A change in Doppler derived Stroke Volume Index of >10% with Passive Leg Raise
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Assessment method [5]
312821
0
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Timepoint [5]
312821
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end of surgery
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Eligibility
Key inclusion criteria
Patients must already be recruited the RELIEF trial (ClinicalTrials.gov Identifier: NCT01424150) which is currently recruiting.
Incusions criteria include adults over 18 years of age and
all types of open or laprascopic assisted abdominal or pelvic surgery with a duration of atleast 2 hours and an expected hospital stay of at least 3 days.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Urgent surgery
ASA 5
Chronic renal failure requiring dialysis
Pulmonary or Cardiac Surgery
Liver Ressection
Minor/Intermediate Surgery
in addition
Patients who may have an inappropriate response to PLR.
Patients with a contraindication to a PLR
Patients in whom an ODM cannot be placed
Patients in whom the primary anaesthetist chooses to use GDT
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Power analysis: increase in stroke volume of 43mls (sd 14) to 52(sd 17) using the oesophageal doppler.
Estimated sample size of 47 in each group (alpha=0.05, power=0.80). We would recruit a total of 100 to allow for drop outs and exclusions.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
16/02/2015
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Actual
1/06/2015
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Date of last participant enrolment
Anticipated
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Actual
21/09/2016
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Date of last data collection
Anticipated
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Actual
21/09/2016
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
3367
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [2]
3368
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
9154
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3065 - Fitzroy
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Recruitment postcode(s) [2]
9155
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
290090
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Other Collaborative groups
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Name [1]
290090
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Australian and New Zealand College of Anaesthetists (ANZCA)
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Address [1]
290090
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ANZCA House,
630 St Kilda Road,
Melbourne Victoria 3004
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Country [1]
290090
0
Australia
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Funding source category [2]
290646
0
Hospital
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Name [2]
290646
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St Vincent's Research Endowment Fund
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Address [2]
290646
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Victoria Parade
Fitzroy Vic 3065
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Country [2]
290646
0
Australia
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Primary sponsor type
Individual
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Name
Dr Tuong Dien Phan
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Address
PO Box 2900
Department of Anaesthesia
St Vincent's Hospital Melbourne
FITZROY VIC 3065
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Country
Australia
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Secondary sponsor category [1]
288789
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None
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Name [1]
288789
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none
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Address [1]
288789
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Country [1]
288789
0
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Other collaborator category [1]
278303
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Individual
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Name [1]
278303
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Phil Peyton
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Address [1]
278303
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Dept of Anaesthesia
Level 2
Austin Tower
Austin Hospital
Studley Rd
Heidelberg 3084
VIC Australia
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Country [1]
278303
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304775
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Alfred Ethics committee
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Ethics committee address [1]
304775
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Commercial Road, Prahran, Vic 3084
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Ethics committee country [1]
304775
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Australia
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Date submitted for ethics approval [1]
304775
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01/11/2014
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Approval date [1]
304775
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29/01/2015
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Ethics approval number [1]
304775
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none
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Summary
Brief summary
Disability free survival after major abdominal surgery is of importance to patients and their care givers. Replacement fluid given to patients is likely to make a difference to this outcome. The RELIEF study looks at a low volume compared to a high volume fluid replacement technique to determine which results in the best outcome. What is relatively unknown is how these two different fluid replacement techniques change the cardiovascular signs that are frequently monitored as part of general anaesthetic care. These cardiovascular monitored signs can include the volume the heart pumps each beat (stroke volume) or the changes in cardiac volume over time (stroke volume variation). These cardiovascular signs are often used to guide how much fluid to give. This is because we know that if the cardiac function does not meet the needs of the extra demands from surgery, it can result in harm to the patient. For example, the patient may require additional drugs to support their circulation or suffer from poor wound healing. We aim to recruit 100 patients who are part of the RELIEF study to observe the changes in cardiovascular function using cardiac monitors. These cardiac monitors are used as part of routine monitoring care and represent established approved devices in clinical monitoring. The information from this study will help determine the usefulness of these signs for the specialist anaesthetic doctor looking after the patient. Careful and accurate monitoring of a patient’s condition can help a clinician tailor the fluid resuscitation for the patient. It can also help identify patients who may need extra support through additional drugs or closer monitoring. As this is an observational study, there will be no direct benefit to the patient. However, the information gained from the study would be of use to clinicians better look after future patients.
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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
51946
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Dr Tuong Phan
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Address
51946
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Department Anaesthesia and Acute Pain
St Vincent's Hospital Melbourne
41 Victoria Parade
PO Box 2900
Fitzroy Vic 3065
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Country
51946
0
Australia
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Phone
51946
0
+61 3 92882211
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Fax
51946
0
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Email
51946
0
[email protected]
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Contact person for public queries
Name
51947
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Tuong Phan
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Address
51947
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Department Anaesthesia and Acute Pain
St Vincent's Hospital Melbourne
41 Victoria Parade
PO Box 2900
Fitzroy Vic 3065
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Country
51947
0
Australia
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Phone
51947
0
+61 3 92882211
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Fax
51947
0
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Email
51947
0
[email protected]
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Contact person for scientific queries
Name
51948
0
Tuong Phan
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Address
51948
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Department Anaesthesia and Acute Pain
St Vincent's Hospital Melbourne
41 Victoria Parade
PO Box 2900
Fitzroy Vic 3065
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Country
51948
0
Australia
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Phone
51948
0
+61 3 92882211
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Fax
51948
0
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Email
51948
0
[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
Consent for public access to patient data was not explicitly obtained.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5783
Ethical approval
367222-(Uploaded-24-07-2019-16-34-47)-Study-related document.pdf
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.
Download to PDF