Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192182505
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Double Blind Randomised
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular: Varicose veins
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Visual analogue scale for pain and bruising
Secondary outcome measures
Duplex ultrasound assessment of lower limb venous system competency
Overall trial start date
30/06/2006
Overall trial end date
01/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Bilateral or unilateral primary varicose veins
2. Mild to moderate varicose veins
3. Agree to participate in study
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
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
Recruitment start date
30/06/2006
Recruitment end date
01/06/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Nottingham University Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary