Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000304437
Ethics application status
Approved
Date submitted
30/05/2007
Date registered
7/06/2007
Date last updated
1/06/2024
Date data sharing statement initially provided
24/09/2019
Date results provided
24/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Anterior 90 degree vs Nissen fundoplication to assess dysphagia in patients undergoing surgery for gastro-oesophageal reflux
Scientific title
Anterior 90 degree vs Nissen fundoplication to assess dysphagia in patients undergoing surgery for gastro-oesophageal reflux
Secondary ID [1] 287806 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastro-oesophageal reflux 1847 0
Condition category
Condition code
Oral and Gastrointestinal 1941 1941 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Random assignment to either Nissen (total) or anterior 90 degree partial fundoplication (fundus wrapped 1/4 way around oesophagus). Outcome is reflux control and side effects (especially dysphagia).
Intervention code [1] 1794 0
Treatment: Surgery
Comparator / control treatment
Comparison of 2 valid surgical operations in RCT
Control group
Active

Outcomes
Primary outcome [1] 2758 0
Dysphagia and reflux symptoms will be determined using a clinical questionnaire
Timepoint [1] 2758 0
At 3 months, and then yearly for 20 years
Secondary outcome [1] 4647 0
No secondary outcome
Timepoint [1] 4647 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)
opaque sealed envelope method
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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2000
Actual
1/01/2000
Date of last participant enrolment
Anticipated
Actual
1/01/2005
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
100
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4573 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 2083 0
Government body
Name [1] 2083 0
National Health and Medical Research Council
Country [1] 2083 0
Australia
Primary sponsor type
University
Name
Department of Surgery, Flinders University
Address
Bedford Park, SA
Country
Australia
Secondary sponsor category [1] 1889 0
University
Name [1] 1889 0
Department of Surgery, Adelaide University
Address [1] 1889 0
Adelaide
Country [1] 1889 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3874 0
Royal Adelaide Hospital
Ethics committee address [1] 3874 0
Ethics committee country [1] 3874 0
Australia
Date submitted for ethics approval [1] 3874 0
Approval date [1] 3874 0
16/04/1998
Ethics approval number [1] 3874 0
980414

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

Contacts
Principal investigator
Name 27897 0
Prof David Watson
Address 27897 0
Dept Surgery
Flinders University
Country 27897 0
Australia
Phone 27897 0
+61882046086
Fax 27897 0
Email 27897 0
[email protected]
Contact person for public queries
Name 10983 0
Professor David Watson
Address 10983 0
Department of Surgery
Flinders Medical Centre
Bedford Park SA 5042
Country 10983 0
Australia
Phone 10983 0
+61 8 82046086
Fax 10983 0
+61 8 82046130
Email 10983 0
[email protected]
Contact person for scientific queries
Name 1911 0
Professor David Watson
Address 1911 0
Department of Surgery
Flinders Medical Centre
Bedford Park SA 5042
Country 1911 0
Australia
Phone 1911 0
+61 8 82046086
Fax 1911 0
+61 8 82046130
Email 1911 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.