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ISRCTN
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ISRCTN13632365
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ClinicalTrials.gov identifier
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Public title
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A Double Blind Randomised Trial of Valve Reinforcement and Vein Removal for the Treatment of Superficial Venous Incompetence
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0192182505
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Study hypothesis
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1. The primary aim of this study is to determine whether reinforcement of the proximal long saphenous vein valve with an exovascular cuff is as effective as removal of the long saphenous vein in the treatment of symptomatic varicose veins at various time intervals. This will be assessed by looking at patients pain levels post operatively and objectively assessing levels of post procedure bruising.
2. Secondary Research Objectives: The secondary aims are to:
2.1 Identify whether the exovascular cuff is cost effective
2.2 Assess time taken to perform the procedures
2.3. See if exovascular cuff promotes early return to normal activity
2.4 Assess long term efficacy by Duplex scan at six weeks, one year, two years and five years 5. compare use of Venocuff with VNUS
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Ethics approval
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Not provided at time of registration
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Study design
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Double Blind Randomised
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular: Varicose veins
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Participants - inclusion criteria
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1. Bilateral or unilateral primary varicose veins
2. Mild to moderate varicose veins
3. Agree to participate in study
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Participants - exclusion criteria
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1. Recurrent varicose veins
2. Thrombophlebitus affecting the LSV or tributaries
3. The ultrasonic finding of an LSV that is very dilated >10mm in female and > 11mm in male
4. Damaged thickened non mobile or absent terminal subterminal LSV values
5. Gross tortuasity along the course of the LSV
6. An inability to render the SFJ competent at operation
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Anticipated start date
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30/06/2006
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Anticipated end date
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01/06/2009
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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60
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Interventions
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There will be 2 concurrent studies: one will involve patients with bilateral primary varicose veins and one will involve patients with unilateral primary varicose veins.
Intervention arms: no interventions withheld, additional interventions - insertion of venocuff rather than high tie and stripping of LSV.
Follow up duplex assessment of lower limb various telephone interviews and photo of patients leg.
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Primary outcome measure(s)
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Visual analogue scale for pain and bruising
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Secondary outcome measure(s)
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Duplex ultrasound assessment of lower limb venous system competency
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Sources of funding
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Nottingham University Hospitals NHS Trust
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Stephen
Goode
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Address
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University Hospital
NHS Trust
B Floor, West Block, Academic Radiology
Derby Road
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Tel
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+44 0115 8231176
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Fax
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+44
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Email
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msxsg@nottingham.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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22/10/2007
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Date ISRCTN assigned
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28/09/2007
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