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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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18 January 2021 |
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Main ID: |
ACTRN12605000035628 |
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Date of registration:
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22/07/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Multicentre Randomised Controlled Trial of Anterior vs Posterior vs Nissen Fundoplication
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Scientific title:
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Anterior versus Posterior versus Nissen Fundoplication for the control of gastro-oesophageal reflux |
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Date of first enrolment:
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31/12/2012 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://anzctr.org.au/ACTRN12605000035628.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Single group;Type of endpoint: Efficacy;
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Contacts
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Name:
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Prof David Watson
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Address:
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Department of Surgery
Flinders Medical Centre
Bedford Park SA 5042
Australia |
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Telephone:
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+61 8 82046086 |
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Email:
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david.watson@flinders.edu.au |
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Affiliation:
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Name:
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Prof David Watson
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Address:
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Department of Surgery
Flinders Medical Centre
Bedford Park SA 5042
Australia |
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Telephone:
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+61 8 82046086 |
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Email:
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david.watson@flinders.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Proven gastro-oesophageal reflux disease by either endoscopic or 24 hour pH monitoring. Antireflux surgery clinically indicated. Fit for surgery. Reflux inadequately controlled by standard medications or unwilling to take lifelong medication for reflux.
Exclusion criteria: No informed consent. Previous surgery for gastro-oesophageal reflux. Very large hiatus hernia (more than 50% of stomach in the chest). PregnantOesophageal motility disorder which precludes Nissen fundoplication.
Age minimum:
18 Years
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Gastro-oesophageal reflux;
Gastro-oesophageal reflux
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Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention(s)
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Laparoscopic fundoplication - Anterior vs Posterior vs Nissen Fundoplication
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Primary Outcome(s)
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Control of Reflux[n/a]
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Secondary Outcome(s)
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Side effects[n/a]
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Secondary ID(s)
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Nil Known
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 01/07/2005
Contact:
Flinders Medical Centre
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Status: Approved
Approval date: 01/07/2005
Contact:
Royal Adelaide Hopsital
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Results
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Results available:
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Date Posted:
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24/09/2019 |
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Date Completed:
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URL:
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