Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000587606
Ethics application status
Approved
Date submitted
27/09/2005
Date registered
4/10/2005
Date last updated
4/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Antireflux Anastomosis Following Oesophagectomy
Scientific title
A randomised study comparing reflux severity after standard end to side oesophago gastric anastomosis versus a fundoplication anastomosis following oesophagectomy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Oesophagectomy Reflux 714 0
Condition category
Condition code
Oral and Gastrointestinal 791 791 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Either a standard oesophago-gastric anastomosis or fundoplicaion anastomosis will be performed.
Intervention code [1] 684 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1010 0
Severity of reflux
Timepoint [1] 1010 0
Assessed at 1, 3, 6 and 12 months following surgery
Secondary outcome [1] 1901 0
Biopsies
Timepoint [1] 1901 0
At 1,3,6 and 12 months will be assessed for histological reflux changes.

Eligibility
Key inclusion criteria
Ivor Lewis Oesophagectomy. Ability to consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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 envelopes until allocation to each patient enrolled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random shuffling of sealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 876 0
Other Collaborative groups
Name [1] 876 0
RACS grant
Country [1] 876 0
Australia
Primary sponsor type
Hospital
Name
University of Melbourne, Department of Surgery, Austin Hospital
Address
Country
Australia
Secondary sponsor category [1] 742 0
None
Name [1] 742 0
N/A
Address [1] 742 0
Country [1] 742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2161 0
Austin Hospital
Ethics committee address [1] 2161 0
Ethics committee country [1] 2161 0
Australia
Date submitted for ethics approval [1] 2161 0
Approval date [1] 2161 0
Ethics approval number [1] 2161 0
Ethics committee name [2] 2162 0
Royal Adelaide Hospital
Ethics committee address [2] 2162 0
Ethics committee country [2] 2162 0
Australia
Date submitted for ethics approval [2] 2162 0
Approval date [2] 2162 0
Ethics approval number [2] 2162 0
Ethics committee name [3] 2163 0
Flinders Medical Centre
Ethics committee address [3] 2163 0
Ethics committee country [3] 2163 0
Australia
Date submitted for ethics approval [3] 2163 0
Approval date [3] 2163 0
Ethics approval number [3] 2163 0
Ethics committee name [4] 2164 0
Royal Hallamshire Hospital
Ethics committee address [4] 2164 0
Ethics committee country [4] 2164 0
Australia
Date submitted for ethics approval [4] 2164 0
Approval date [4] 2164 0
Ethics approval number [4] 2164 0

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

Contacts
Principal investigator
Name 36264 0
Address 36264 0
Country 36264 0
Phone 36264 0
Fax 36264 0
Email 36264 0
Contact person for public queries
Name 9873 0
Ahmad Aly
Address 9873 0
Department of Surgery
Austin Hospital
Level 8
Kance Townsend Building (LTB)
Studley Rd
Heidelberg VIC 3084
Country 9873 0
Australia
Phone 9873 0
+61 3 94965000
Fax 9873 0
Email 9873 0
[email protected]
Contact person for scientific queries
Name 801 0
Ahmad Aly
Address 801 0
Department of Surgery
Austin Hospital
Level 8
Kance Townsend Building (LTB)
Studley Rd
Heidelberg VIC 3084
Country 801 0
Australia
Phone 801 0
+61 3 94965000
Fax 801 0
Email 801 0
[email protected]

No information has been provided regarding IPD availability


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.