Contact information
Type
Scientific
Primary contact
Mr Michael Gough
ORCID ID
Contact details
Vascular Surgical Unit
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 0113 392 3951
michael.gough@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436169958
Study information
Scientific title
Acronym
Study hypothesis
Modifications of laser technique might result better clinical outcome in the treatment of varicose veins due to sapheno-femoral and long saphenous incompetence. This study is designed to answer 2 questions:
1. Do these modifications result in improved symptom relief and cosmetic appearance after treatment of varicose veins?
2. Does one of these techniques reduce the total number of follow up sclerotherapy sessions needed to complete the treatment of 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
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular: Varicose veins
Intervention
2 different types of modified EVLT (endovenous laser treatment) techniques vs standard EVLT technique.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. The total number of follow up sclerotherapy sessions required to complete the treatment.
2. Technical success: determined by duplex ultrasound of LSV:
2.1 Successful: occlusion and non compressibility of the LSV without blood flow throughout the treated length
2.2 Partial response: segmental occlusion of LSV and abolition of distal reflux
2.3 Failure: reflux in treated LSV any time after treatment
3. Improvement in symptoms, using the Aberdeen Vein Questionnaire, a previously validated disease-specific quality of life instrument
4. Review and quantification of varicosities on post-EVLT photographs both prior to and after completion of sclerotherapy
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2005
Overall trial end date
01/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
207 - Each study group comprise 69 (follow-up completed) patients. Group 1 (standard EVLT) is the control group and will be of the same size as group 2 and 3.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2005
Recruitment end date
01/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Vascular Surgical Unit
Leeds
LS1 3EX
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
Leeds Teaching Hospitals NHS Trust (UK)
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
Basic results (scientific)
Publication list
2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18440756
Publication citations
-
Results
Theivacumar NS, Dellagrammaticas D, Mavor AI, Gough MJ, Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial., J. Vasc. Surg., 2008, 48, 1, 173-178, doi: 10.1016/j.jvs.2008.01.062.