Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000303448
Ethics application status
Approved
Date submitted
30/05/2007
Date registered
6/06/2007
Date last updated
2/03/2021
Date data sharing statement initially provided
24/09/2019
Date results information initially provided
24/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of Anterior 180 degree vs Nissen fundoplication to control and assess the contol of reflux and side effects in patients undergonig surgery for gastro-oesophageal reflux
Scientific title
A randomised trial of Anterior 180 degree vs Nissen fundoplication to control and assess the contol of reflux and side effects in patients undergonig surgery for gastro-oesophageal reflux
Secondary ID [1] 287804 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastro-oesophageal reflux 1846 0
Condition category
Condition code
Oral and Gastrointestinal 1940 1940 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 types of fundoplication for gastro-oesophageal reflux compared. 1) Nissen (total) fundoplication 2) Anterior 180 degree partial (stomach sutured across front of oesophagus) fundoplication.
Intervention code [1] 1792 0
Treatment: Surgery
Comparator / control treatment
Comparison of 2 equally valid procedures in RCT
Control group
Active

Outcomes
Primary outcome [1] 2757 0
Dysphagia and reflux symptoms will be determined using a clinical questionnaire
Timepoint [1] 2757 0
At 3 months, and then yearly for 20 years
Secondary outcome [1] 4646 0
Dysphagia and other symptoms will be determined using a clinical questionnaire
Timepoint [1] 4646 0
At 3 months, and then yearly for 20 years.

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 fundoplicationsevere 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)
sealed opaque envelope technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
120 Envelopes prepared by independent nurse (60 = treatment, 60=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
1/01/1996
Actual
1/01/1996
Date of last participant enrolment
Anticipated
Actual
31/12/1997
Date of last data collection
Anticipated
1/01/2020
Actual
1/01/2020
Sample size
Target
100
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4571 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 2082 0
Government body
Name [1] 2082 0
National Health and Medical Research Council
Country [1] 2082 0
Australia
Primary sponsor type
University
Name
Department of Surgery, Flinders University
Address
Bedford Park, SA
Country
Australia
Secondary sponsor category [1] 1888 0
University
Name [1] 1888 0
Department of Surgery, Adelaide University
Address [1] 1888 0
Adelaide
Country [1] 1888 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3873 0
Royal Adelaide Hospital
Ethics committee address [1] 3873 0
Port Road, Adelaide, SA, 5000
Ethics committee country [1] 3873 0
Australia
Date submitted for ethics approval [1] 3873 0
Approval date [1] 3873 0
20/04/1995
Ethics approval number [1] 3873 0
950413

Summary
Brief summary
Random assignment to either Nissen or anterior partial fundoplication. Outcome is relfux control and side effects (especially dysphagia)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27895 0
Prof David Watson
Address 27895 0
Dept Surgery
Flinders University
Country 27895 0
Australia
Phone 27895 0
+61882046086
Fax 27895 0
Email 27895 0
david.watson@flinders.edu.au
Contact person for public queries
Name 10981 0
Prof Professor David Watson
Address 10981 0
Dept of Surgery, Flinders Medical Centre
Bedford Park
SA 5042
Country 10981 0
Australia
Phone 10981 0
08 82046086
Fax 10981 0
08 82046130
Email 10981 0
david.watson@flinders.edu.au
Contact person for scientific queries
Name 1909 0
Prof Professor David Watson
Address 1909 0
Dept of Surgery
Flinders Medical Centre
Bedford Park
South Australia 5042
Country 1909 0
Australia
Phone 1909 0
08 82046086
Fax 1909 0
08 82046130
Email 1909 0
david.watson@flinders.edu.au

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 Cai W, Watson DI, Lally CJ, Devitt PG, Game PA, Ja... [More Details]

Documents added automatically
No additional documents have been identified.