Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001185550
Ethics application status
Approved
Date submitted
30/05/2007
Date registered
3/11/2015
Date last updated
2/03/2021
Date data sharing statement initially provided
24/09/2019
Date results provided
24/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Laparoscopic Nissen fundoplication with anterior vs posterior hiatal repair to assess dysphagia in patients undergoing surgery for gastro-oesophageal reflux
Scientific title
Laparoscopic Nissen fundoplication with anterior vs posterior hiatal repair to assess dysphagia in patients undergoing surgery for gastro-oesophageal reflux
Secondary ID [1] 287767 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastro-oesophageal reflux 2162 0
Condition category
Condition code
Oral and Gastrointestinal 2257 2257 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 types of hiatal repair during Nissen fundoplication for gastro-oesophageal reflux were compared. 1) anterior repair (hiatus sutured in front of the oesophagus 2) posterior repair (hiatus sutured behind the oesophagus)
Intervention code [1] 1793 0
Treatment: Surgery
Comparator / control treatment
Both groups underwent Nissen fundoplication. Comparison of 2 variants of hiatal repair
Control group
Active

Outcomes
Primary outcome [1] 3119 0
Dysphagia and other symptoms will be determined using a clinical questionairre
Timepoint [1] 3119 0
At 3 months, and then yearly for 20 years
Secondary outcome [1] 5236 0
A barium meal Xray
Timepoint [1] 5236 0
performed 6 months after surgery

Eligibility
Key inclusion criteria
Suitable for a laparoscopic Nissen fundoplication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not suitable for laproscopic Nissen fundoplication
severe 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?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
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
Actual
1/07/1997
Date of last participant enrolment
Anticipated
Actual
31/10/1999
Date of last data collection
Anticipated
1/01/2020
Actual
1/01/2020
Sample size
Target
100
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4537 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 2418 0
Government body
Name [1] 2418 0
National Health and Medical Research Council
Country [1] 2418 0
Australia
Primary sponsor type
University
Name
Department of Surgery, Flinders University
Address
Bedford Park
Country
Australia
Secondary sponsor category [1] 2191 0
University
Name [1] 2191 0
Department of Surgery, Adelaide University
Address [1] 2191 0
Adelaide
Country [1] 2191 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4248 0
Royal Adelaide Hospital
Ethics committee address [1] 4248 0
Ethics committee country [1] 4248 0
Australia
Date submitted for ethics approval [1] 4248 0
Approval date [1] 4248 0
27/02/1997
Ethics approval number [1] 4248 0
970218

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

Contacts
Principal investigator
Name 27896 0
Prof David Watson
Address 27896 0
Dept Surgery
Flinders University
Country 27896 0
Australia
Phone 27896 0
+61882046086
Fax 27896 0
Email 27896 0
[email protected]
Contact person for public queries
Name 10982 0
Professor David Watson
Address 10982 0
Dept of Surgery
Flinders Medical Centre
Bedford Park SA 5042
Country 10982 0
Australia
Phone 10982 0
08 82046086
Fax 10982 0
08 82046130
Email 10982 0
[email protected]
Contact person for scientific queries
Name 1910 0
Professor David Watson
Address 1910 0
Dept of Surgery
Flinders Medical Centre
Bedford Park SA 5042
Country 1910 0
Australia
Phone 1910 0
08 82046086
Fax 1910 0
08 82046130
Email 1910 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.