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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06839248
Registration number
NCT06839248
Ethics application status
Date submitted
11/02/2025
Date registered
21/02/2025
Date last updated
26/06/2025
Titles & IDs
Public title
Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
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Scientific title
Effect of Fasting Recommendations on Residual Gastric Contents Among Patients Using Glucagon-like Peptide-1 Receptor Agonists: A Randomised Controlled Trial
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Secondary ID [1]
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2024/PID00396
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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:
Residual Gastric Contents
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Pulmonary Aspiration of Gastric Contents
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - 24-hour clear liquid diet
Other interventions - Standard fasting guidelines
Experimental: 24-hour clear liquid diet -
Active comparator: Standard fasting guidelines -
Other interventions: 24-hour clear liquid diet
Participants randomly assigned to this arm will be instructed to follow a 24-hour clear liquid diet, defined as NPO for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.
Other interventions: Standard fasting guidelines
Participants randomly assigned to this arm will be instructed to follow the ASA and ANZCA standards for preoperative fasting prior to presenting for their trial visit. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Residual gastric contents
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Assessment method [1]
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Difference in proportion of participants who present with increased residual gastric contents, defined as a grade 2 or 3 antrum, as assessed by gastric ultrasound using the clinical algorithm by Perlas and colleagues.
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Timepoint [1]
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Immediately following fasting intervention
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Secondary outcome [1]
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Solid content
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Assessment method [1]
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Difference in proportion of participants who present with solid content, defined as a grade 3 antrum, assessed by gastric ultrasound using the clinical algorithm by Perlas and colleagues.
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Timepoint [1]
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Immediately following fasting intervention
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Secondary outcome [2]
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Thirst
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Assessment method [2]
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Mean difference in thirst, assessed using the thirst distress and thirst intensity Visual Analogue Scales. Participants rate their level of thirst distress along a scale of 0-10cm, where 10cm represents "extreme distress" and the end closest to 0cm the represents "not distressed". Participants rate their level of thirst intensity along a scale of 0-10cm, where 10cm represents "intense thirst" and the end closest to 0cm the represents "not thirsty". The average of the thirst intensity and the thirst distress score is calculated.
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Timepoint [2]
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Immediately following fasting intervention
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Secondary outcome [3]
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Hunger
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Assessment method [3]
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Mean difference in hunger, assessed using the Hunger and Satiety Visual Analogue Scale. Participants rate their level of hunger along a scale of 0-10cm, where 10cm represents "I have never been more hungry, and the end closest to 0cm the represents "I am not hungry at all".
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Timepoint [3]
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Immediately following fasting intervention
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Secondary outcome [4]
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Nausea
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Assessment method [4]
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Mean difference in nausea, assessed using a Visual Analogue Scale. Participants rate their level of nausea along a scale of 0-10cm, where 10cm represents "worst imaginable nausea", and the end closest to 0cm the represents "no nausea".
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Timepoint [4]
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Immediately following fasting intervention
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Secondary outcome [5]
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Fatigue
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Assessment method [5]
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Mean difference in fatigue, assessed using a Visual Analogue Scale. Participants rate their level of fatigue along a scale of 0-10cm, where 10cm represents "extreme fatigue", and the end closest to 0cm the represents "not fatigued at all".
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Timepoint [5]
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Immediately following fasting intervention
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Secondary outcome [6]
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Anxiety
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Assessment method [6]
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Mean difference in anxiety, assessed using the Visual Analogue Scale for Anxiety (VAS-A). Participants rate their level of anxiety along a scale of 0-10cm, where 10cm represents "most anxious I can imagine, and the end closest to 0cm the represents "not at all anxious".
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Timepoint [6]
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Immediately following fasting intervention
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Secondary outcome [7]
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Adherence to intervention
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Assessment method [7]
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Difference in proportion of participants who adhere to allocated intervention, assessed using a dedicated case report form.
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Timepoint [7]
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Immediately following fasting intervention
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Secondary outcome [8]
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Time since last oral intake of solid foods
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Assessment method [8]
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Mean difference in time since last oral intake of solid foods, assessed using a dedicated case report form.
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Timepoint [8]
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Immediately following fasting intervention
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Secondary outcome [9]
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Time since last oral intake of clear liquids
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Assessment method [9]
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Mean difference in time since last oral intake of clear liquids, assessed using a dedicated case report form.
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Timepoint [9]
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Immediately following fasting intervention
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Eligibility
Key inclusion criteria
* Age =18 years old at enrolment.
* Have regularly administered any type of once-weekly GLP-1 RA medication for a period of at least one month prior to randomisation.
* If allocated to follow standard fasting guidelines, willing to adhere to ASA and ANZCA preoperative fasting requirements. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.
* If allocated to follow a 24-hour clear liquid diet, willing to adhere to nothing-by-mouth (NPO) for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.
* Provide a signed and dated informed consent form for study participation in line with the requirements of the human research ethics committee (HREC) of the study site.
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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
Participants meeting any of the following criteria, indicative of abnormal anatomy and not validated by gastric ultrasound, will be excluded from this trial:
* Has a recent history of gastrointestinal bleed within the previous 1 month from enrolment.
* Has a history of previous lower oesophageal or gastric surgery.
* Has a known abnormal upper gastrointestinal anatomy, including hiatus hernia or gastric tumours.
In addition, participants meeting any the of following criteria will be excluded from this trial:
* Participant reports having been previously diagnosed with a clinically significant gastric emptying abnormality such as gastroparesis.
* Unable to assume the right lateral decubitus position required for gastric ultrasound assessment.
* Participant has difficulty fully understanding PICF or study materials due to a primary language other than English.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/06/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
9/02/2026
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Actual
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Sample size
Target
154
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Melbourne Gastro Oesophageal Surgery (MGOS) - Melbourne
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Recruitment hospital [2]
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St Vincent's Hospital Melbourne - Melbourne
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Recruitment postcode(s) [1]
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3002 - Melbourne
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Recruitment postcode(s) [2]
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3065 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
St Vincent's Hospital Melbourne
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this randomised controlled trial is to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on the proportion of participants who present with increased residual gastric contents during their study visit. It also aims to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on: * Solid content, defined as a grade 3 antrum. * Patient-reported outcome measures (PROMs), including thirst, hunger, nausea, fatigue, and anxiety. * Compliance measures, including adherence with the intervention, time since last oral intake of solid foods, and time since last oral intake of clear liquids. We will enrol adults who are currently using any once-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) medication. Participants will be allocated in a 1:1 ratio to follow a 24-hour clear liquid diet or standard fasting guidelines prior to attending a study visit where participants will undergo a blinded gastric ultrasound assessment.
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Trial website
https://clinicaltrials.gov/study/NCT06839248
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Trial related presentations / publications
Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available. Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023 Feb 1;138(2):132-151. doi: 10.1097/ALN.0000000000004381. Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available. Carey S, Waller J, Wang LY, Ferrie S. Qualifying thirst distress in the acute hospital setting-validation of a patient-reported outcome measure. Journal of Perioperative Nursing.2021;34(4):e38-e44. Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083. Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x. Glaus A. Assessment of fatigue in cancer and non-cancer patients and in healthy individuals. Support Care Cancer. 1993 Nov;1(6):305-15. doi: 10.1007/BF00364968. Desrame J, Baize N, Anota A, Laribi K, Stefani L, Hjiej S, Nabirotchkina E, Zelek L, Choquet S. Fatigue visual analogue scale score correlates with quality of life in cancer patients receiving epoetin alfa (Sandoz) for chemotherapy-induced anaemia: The CIROCO study. Cancer Treat Res Commun. 2023;37:100781. doi: 10.1016/j.ctarc.2023.100781. Epub 2023 Nov 23. Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available. Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.
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Public notes
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Contacts
Principal investigator
Name
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Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD
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Address
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St Vincent's Hospital Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Prof Michelle Dowsey, BHealthSci(Nursing), MEpi, PhD
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Address
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Country
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Phone
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03 9231 3955
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06839248
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