Trial registered on ANZCTR


Trial ID
ACTRN12605000035628
Ethics application status
Approved
Date submitted
20/07/2005
Date registered
22/07/2005
Date last updated
19/09/2017
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

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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 164 0
Self funded/Unfunded
Name [1] 164 0
Address [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
Multicentre prospective double blind randomized controlled trial comparing 3 surgical procedures for gastro-oesophageal reflux. All groups will undergo a clinically acceptable operation, according to standard clinical indications.

The study will be performed in multiple centres throughout Australia and New Zealand. The study will be coordinated from FMC and RAH in SA.

Patients will be recruited over a 2 year period. Follow-up will continue for up to 20 years.
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
david.watson@flinders.edu.au
Contact person for public queries
Name 9232 0
Prof 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
david.watson@flinders.edu.au
Contact person for scientific queries
Name 160 0
Prof 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
david.watson@flinders.edu.au