Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000035628
Ethics application status
Approved
Date submitted
20/07/2005
Date registered
22/07/2005
Date last updated
1/06/2024
Date data sharing statement initially provided
24/09/2019
Date results provided
24/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Multicentre Randomised Controlled Trial of Anterior vs Posterior vs Nissen Fundoplication
Scientific title
Anterior versus Posterior versus Nissen Fundoplication for the control of gastro-oesophageal reflux
Secondary ID [1] 287837 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-oesophageal reflux 98 0
Condition category
Condition code
Oral and Gastrointestinal 119 119 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laparoscopic fundoplication - Anterior vs Posterior vs Nissen Fundoplication
Intervention code [1] 43 0
Treatment: Surgery
Comparator / control treatment
3 surgical variants compared in RCT
Control group
Active

Outcomes
Primary outcome [1] 150 0
Control of Reflux
Timepoint [1] 150 0
n/a
Secondary outcome [1] 331 0
Side effects
Timepoint [1] 331 0
n/a

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
shuffled envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
8/01/2005
Actual
31/12/2012
Date of last participant enrolment
Anticipated
Actual
31/12/2012
Date of last data collection
Anticipated
31/12/2032
Actual
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 164 0
Self funded/Unfunded
Name [1] 164 0
Country [1] 164 0
Primary sponsor type
Charities/Societies/Foundations
Name
ISDE - Australasian section
Address
No address
Country
Australia
Secondary sponsor category [1] 119 0
None
Name [1] 119 0
nil
Address [1] 119 0
Country [1] 119 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 909 0
Flinders Medical Centre
Ethics committee address [1] 909 0
Ethics committee country [1] 909 0
Australia
Date submitted for ethics approval [1] 909 0
Approval date [1] 909 0
01/07/2005
Ethics approval number [1] 909 0
Ethics committee name [2] 910 0
Royal Adelaide Hopsital
Ethics committee address [2] 910 0
Ethics committee country [2] 910 0
Australia
Date submitted for ethics approval [2] 910 0
Approval date [2] 910 0
01/07/2005
Ethics approval number [2] 910 0
n/a

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

Contacts
Principal investigator
Name 35981 0
Prof David Watson
Address 35981 0
Dept Surgery Flinders University
Country 35981 0
Australia
Phone 35981 0
+61882046086
Fax 35981 0
Email 35981 0
[email protected]
Contact person for public queries
Name 9232 0
David Watson
Address 9232 0
Department of Surgery Flinders Medical Centre Bedford Park SA 5042
Country 9232 0
Australia
Phone 9232 0
+61 8 82046086
Fax 9232 0
+61 8 82046130
Email 9232 0
[email protected]
Contact person for scientific queries
Name 160 0
David Watson
Address 160 0
Department of Surgery Flinders Medical Centre Bedford Park SA 5042
Country 160 0
Australia
Phone 160 0
+61 8 82046086
Fax 160 0
+61 8 82046130
Email 160 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
SourceTitleYear of PublicationDOI
EmbaseRandomized controlled trial of laparoscopic anterior 180degree partial versus posterior 270degree partial fundoplication.2015https://dx.doi.org/10.1111/ans.12476
N.B. These documents automatically identified may not have been verified by the study sponsor.