Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084174061
Study information
Scientific title
Acronym
Study hypothesis
Is Endo Venous Laser Therapy (EVLT) superior to conventional surgery for Short Saphenous system varicose veins?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Short saphenous system varicose veins
Intervention
Data will be collected using an IBM computer and a specifically designed Microsoft Access database. The primary outcome measure will be compared between the groups by a chi-square test with continuity correction. Quality of life measures at each time point will be compared between the groups by an analysis of covariance, adjusting for the corresponding baseline values. Statistical advice will be sought from Dr Eric Gardiner, statistical consultant, who holds an honorary contract with the Hull and East Yorkshire Hospitals Trust. Health Economic advice regarding cost effectiveness / benefit analysis will be sought from the Centre of Health Economics, the University of York.
Randomisation will be carried out using envelopes method.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
Residual SPJ incompetence on Duplex ultrasound
Secondary outcome measures
Not provided at time of registration
Overall trial start date
15/09/2005
Overall trial end date
01/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. C2-C5 graded varicose veins
2. Patients that have demonstrated to have isolated SPJ incompetence and/or SSV reflux on Duplex scan
3. Patients in whom the most appropriate treatment is surgery (opinion of the patient/surgeon)
5. Patients able to give informed written consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
106
Participant exclusion criteria
1. Patients whose varicose veins will be conservatively managed
2. Inability to give informed written consent
3. Symptomatic varicose veins which on venous duplex are not attributable to SPJ incompetence and SSV reflux
4. Evidence of deep venous reflux on duplex scan
5. Patients on anticoagulants
Recruitment start date
15/09/2005
Recruitment end date
01/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Alderson House
Hull
HU3 2JZ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 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
The North and South Bank Research and Development Consortium (UK)
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
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16802211
Publication citations
-
Results
Mekako AI, Hatfield J, Bryce J, Lee D, McCollum PT, Chetter I, A nonrandomised controlled trial of endovenous laser therapy and surgery in the treatment of varicose veins., Ann Vasc Surg, 2006, 20, 4, 451-457, doi: 10.1007/s10016-006-9095-y.