A Double Blind Randomised Trial of Valve Reinforcement and Vein Removal for the Treatment of Superficial Venous Incompetence
ISRCTN | ISRCTN13632365 |
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DOI | https://doi.org/10.1186/ISRCTN13632365 |
Secondary identifying numbers | N0192182505 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 28/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Stephen Goode
Scientific
Scientific
University Hospital
NHS Trust
B Floor, West Block, Academic Radiology
Derby Road
Nottingham
NG7 2UH
United Kingdom
Phone | +44 0115 8231176 |
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Study information
Study design | Double Blind Randomised |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | Visual analogue scale for pain and bruising |
Secondary outcome measures | Duplex ultrasound assessment of lower limb venous system competency |
Overall study start date | 30/06/2006 |
Completion date | 01/06/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 60 |
Key inclusion criteria | 1. Bilateral or unilateral primary varicose veins 2. Mild to moderate varicose veins 3. Agree to participate in study |
Key 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 |
Date of first enrolment | 30/06/2006 |
Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Nottingham University Hospitals NHS Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |