A Double Blind Randomised Trial of Valve Reinforcement and Vein Removal for the Treatment of Superficial Venous Incompetence

ISRCTN	ISRCTN13632365
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

University Hospital
NHS Trust
B Floor, West Block, Academic Radiology
Derby Road
Nottingham
NG7 2UH
United Kingdom

Phone	+44 0115 8231176

Study information

Study design	Double Blind Randomised
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
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

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	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
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