Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000298415
Ethics application status
Approved
Date submitted
30/05/2007
Date registered
4/06/2007
Date last updated
1/06/2024
Date data sharing statement initially provided
8/10/2019
Date results information initially provided
8/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multicentre randomised trial of Anterior 90 degree vs Nissen fundoplication for the treatment of patients with gastro-oesophageal reflux
Scientific title
Multicentre randomised trial of Anterior 90 degree vs Nissen fundoplication for the treatment of patients with gastro-oesophageal reflux
Secondary ID [1] 287805 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastro-oesophageal reflux 1840 0
Condition category
Condition code
Oral and Gastrointestinal 1934 1934 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anterior 90 degree (oesophagus wrapped 1/4 way around oesophagus) vs Nissen (oesophagus wrapped all the way around oesophagus) fundoplication in patients undergoing surgery for reflux.
Intervention code [1] 1795 0
Treatment: Surgery
Comparator / control treatment
Comparison of 2 valid operations for reflux in a RCT
Control group
Active

Outcomes
Primary outcome [1] 2749 0
Dysphagia and reflux symptoms will be determined using a clinical questionnaire
Timepoint [1] 2749 0
At 3 months, and then yearly for 20 years
Secondary outcome [1] 4641 0
n/a
Timepoint [1] 4641 0
n/a

Eligibility
Key inclusion criteria
Suitable for a laparoscopic Nissen fundoplication
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not suitable for laparoscopic Nissen fundoplicationlarge hiatus herniasevere oesophageal motility disorder

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)
closed envelope method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
200 Envelopes prepared by independent nurse (100 = treatment, 100=control), and shuffled extensively.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
patients and nurse undertaking follow-up blinded as to which operation was performed
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2001
Actual
1/01/2001
Date of last participant enrolment
Anticipated
Actual
1/01/2003
Date of last data collection
Anticipated
1/01/2023
Actual
1/01/2023
Sample size
Target
120
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4572 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 2078 0
Government body
Name [1] 2078 0
National Health and Medical Research Council
Country [1] 2078 0
Australia
Primary sponsor type
University
Name
Department of Surgery, Flinders University
Address
Bedford Park, SA
Country
Australia
Secondary sponsor category [1] 1883 0
University
Name [1] 1883 0
Department of Surgery, Adelaide University
Address [1] 1883 0
Adelaide
Country [1] 1883 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3862 0
Flinders Medical Centre
Ethics committee address [1] 3862 0
Bedford Park, SA, 5042
Ethics committee country [1] 3862 0
Australia
Date submitted for ethics approval [1] 3862 0
Approval date [1] 3862 0
27/07/1999
Ethics approval number [1] 3862 0
133/99
Ethics committee name [2] 3863 0
Royal Adelaide Hospital
Ethics committee address [2] 3863 0
P0rt Road, Adelaide, SA, 5000
Ethics committee country [2] 3863 0
Australia
Date submitted for ethics approval [2] 3863 0
Approval date [2] 3863 0
27/07/1999
Ethics approval number [2] 3863 0
990713
Ethics committee name [3] 3864 0
Royal Brisbane Hospital
Ethics committee address [3] 3864 0
Butterfield St, Herston QLD 4029
Ethics committee country [3] 3864 0
Australia
Date submitted for ethics approval [3] 3864 0
Approval date [3] 3864 0
Ethics approval number [3] 3864 0
Ethics committee name [4] 3865 0
Nepean Hospital
Ethics committee address [4] 3865 0
Derby Street Kingswood NSW 2747
Ethics committee country [4] 3865 0
Australia
Date submitted for ethics approval [4] 3865 0
Approval date [4] 3865 0
Ethics approval number [4] 3865 0
Ethics committee name [5] 3866 0
Geelong Hospital
Ethics committee address [5] 3866 0
Bellerine St, Geelong, Vic, 3220
Ethics committee country [5] 3866 0
Australia
Date submitted for ethics approval [5] 3866 0
Approval date [5] 3866 0
Ethics approval number [5] 3866 0
Ethics committee name [6] 3867 0
Fremantle Hospital
Ethics committee address [6] 3867 0
Alma Street, Fremantle, WA, 6160
Ethics committee country [6] 3867 0
Australia
Date submitted for ethics approval [6] 3867 0
Approval date [6] 3867 0
Ethics approval number [6] 3867 0
Ethics committee name [7] 3868 0
Auckland Hospital
Ethics committee address [7] 3868 0
2 Park Rd, Grafton, Auckland 1023, New Zealand
Ethics committee country [7] 3868 0
New Zealand
Date submitted for ethics approval [7] 3868 0
Approval date [7] 3868 0
Ethics approval number [7] 3868 0

Summary
Brief summary
Random assignment to either Nissen or anterior 90 degree partial fundoplication. Outcome is reflux control and side effects (especially dysphagia). Trial conducted in 6 cities in Australia and New Zealand
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27898 0
Prof David Watson
Address 27898 0
Dept Surgery
Flinders University
Country 27898 0
Australia
Phone 27898 0
+61882046086
Fax 27898 0
Email 27898 0
[email protected]
Contact person for public queries
Name 10984 0
Prof Professor David Watson
Address 10984 0
Dept of Surgery, Flinders Medical Centre
Bedford Park
SA 5042
Country 10984 0
Australia
Phone 10984 0
08 82046086
Fax 10984 0
08 82046130
Email 10984 0
[email protected]
Contact person for scientific queries
Name 1912 0
Prof Professor David Watson
Address 1912 0
Dept of Surgery, Flinders Medical Centre
Bedford Park SA 5042
Country 1912 0
Australia
Phone 1912 0
08 82046086
Fax 1912 0
08 82046130
Email 1912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Nijjar RS, Watson DI, Jamieson GG, Archer S, Besse... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLong-term follow-up of two randomized trials comparing laparoscopic Nissen 360degree with anterior 90degree partial fundoplication.2020https://dx.doi.org/10.1002/bjs.11327
N.B. These documents automatically identified may not have been verified by the study sponsor.