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Trial registered on ANZCTR


Registration number
ACTRN12606000035527
Ethics application status
Approved
Date submitted
23/01/2006
Date registered
25/01/2006
Date last updated
25/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Recurrence of varicose veins following superficial venous surgery - mechanism and prevention.
Scientific title
Recurrence of varicose veins following superficial venous surgery - mechanism and prevention.
Universal Trial Number (UTN)
Trial acronym
The Patch Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrence of varicose veins 998 0
Condition category
Condition code
Cardiovascular 1073 1073 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled prospective study of the use of a mechanical barrier to prevent neovascularisation recurrence of varicose veins following surgery. Two groups will be compared.
- Group A: Complete surgical correction of venous reflux based on duplex ultrasound mapping and routine surgical techniques.
- Group B: Treatment group: As for Group A plus surgical patch (PTFE) placed over the ligated saphenofemoral junction to obstruct new vessel formation.
- Follow up of all patients (ultrasound, air plethysmography and clinical evaluation) for 5 years: 1 month, 6 months, 1 year, 3 years and 5 years.
Intervention code [1] 844 0
Other interventions
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1438 0
The recurrence of ultrasound detected venous reflux at the ligated saphenofemorl junction site in the groin due to neovascularisation.
Timepoint [1] 1438 0
Outcome measured at all follow up timepoints.
Secondary outcome [1] 2541 0
Clinical recurrence
Timepoint [1] 2541 0
Evaluated at each time interval.
Secondary outcome [2] 2542 0
Venous clinical severity score
Timepoint [2] 2542 0
Evaluated at each time interval.
Secondary outcome [3] 2543 0
Patient satisfaction questionnaire.
Timepoint [3] 2543 0
Evaluated at each time interval.

Eligibility
Key inclusion criteria
Clear indication for superficial cein surgery (primary or recurrent)- Reasonable expectation for good compliance over study period.
Minimum age
16 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Life expectancy less than two years after surgery- Inaccessible distance from Dunedin- Severe immobility.

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)
Allocation: Not recorded in patients record or operative account, not told to patient, not recorded in research follow up protocols, surgeons do not communicate allocation to assessment staff. Envelopes, which contain the number indicating type of treatment the patient will receive, will be opened at time of surgery. An independant person will randomise, administer and maintain the randomisation and code until analyses complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by random numbers in blocks for each participating surgeon. Envelopes, which contain the number indicating type of treatment the patient will receive, will be opened at the time of surgery. An independent person will randomise, administer and maintain the randomisation and code until analyses complete. Random numbers are computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 259 0
New Zealand
State/province [1] 259 0

Funding & Sponsors
Funding source category [1] 1173 0
Charities/Societies/Foundations
Name [1] 1173 0
Otago Medical Research Foundation
Address [1] 1173 0
Country [1] 1173 0
New Zealand
Funding source category [2] 1174 0
University
Name [2] 1174 0
Department of Surgery, Dunedin School of medicine
Address [2] 1174 0
Country [2] 1174 0
New Zealand
Funding source category [3] 1175 0
Government body
Name [3] 1175 0
New Zealand Lottery Board Medical Research
Address [3] 1175 0
Country [3] 1175 0
New Zealand
Primary sponsor type
University
Name
Department of Surgery, Dunedin School of Medicine
Address
Country
New Zealand
Secondary sponsor category [1] 1035 0
None
Name [1] 1035 0
None
Address [1] 1035 0
Country [1] 1035 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2493 0
Southern Regional Ethics Committee
Ethics committee address [1] 2493 0
Ethics committee country [1] 2493 0
New Zealand
Date submitted for ethics approval [1] 2493 0
Approval date [1] 2493 0
Ethics approval number [1] 2493 0

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

Contacts
Principal investigator
Name 35141 0
Address 35141 0
Country 35141 0
Phone 35141 0
Fax 35141 0
Email 35141 0
Contact person for public queries
Name 10033 0
Professor Andre van Rij
Address 10033 0
Department of Surgery
Dunedin School of Medicine
PO Box 913
Dunedin
Country 10033 0
New Zealand
Phone 10033 0
+64 3 4740999 ext. 8834
Fax 10033 0
Email 10033 0
andre.vanrij@stonebow.otago.ac.nz
Contact person for scientific queries
Name 961 0
Professor Andre van Rij
Address 961 0
Department of Surgery
Dunedin School of Medicine
PO Box 913
Dunedin
Country 961 0
New Zealand
Phone 961 0
+64 3 4740999 ext. 8834
Fax 961 0
Email 961 0
andre.vanrij@stonebow.otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary