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 designDouble Blind Randomised
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectives1. 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) studiedCardiovascular: Varicose veins
InterventionThere 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 typeOther
Primary outcome measureVisual analogue scale for pain and bruising
Secondary outcome measuresDuplex ultrasound assessment of lower limb venous system competency
Overall study start date30/06/2006
Completion date01/06/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants60
Key inclusion criteria1. Bilateral or unilateral primary varicose veins
2. Mild to moderate varicose veins
3. Agree to participate in study
Key exclusion criteria1. 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 enrolment30/06/2006
Date of final enrolment01/06/2009

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan