Plain English Summary
Background and study aims
Small saphenous varicose veins are swollen and enlarged veins – usually blue or dark purple – that are found on the legs. The aim of this study is to compare three treatments for small saphenous varicose veins: endovenous laser treatment, ultrasound-guided foam sclerotherapy, and conventional surgery. Endovenous laser treatment involves having a catheter inserted into the affected vein; a tiny laser is passed through the catheter that delivers short bursts of energy to heat up the vein and seal it closed. Ultrasound-guided foam sclerotherapy involves injecting special foam into the affected vein, which scars the vein and seals it closed.
Who can participate?
Patients aged 18-75 with varicose veins
What does the study involve?
Participants are randomly allocated to be treated with either endovenous laser treatment, ultrasound-guided foam sclerotherapy, or conventional surgical removal of the short saphenous vein. Participants are followed up after 3 days, 1 month, 1 year, 3 years, and 5 years to assess treatment effectiveness and recurrence of the varicose veins.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Åreknudeklinikken (Denmark)
When is the study starting and how long is it expected to run for?
September 2010 to September 2020
Who is funding the study?
Foundation of the National Health Security System (Fonden for faglig udvikling af speciallægepraksis) (Denmark)
Who is the main contact?
Dr Lars H. Rasmussen
lhr@varix.dk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lars H. Rasmussen
ORCID ID
Contact details
Nordre Kystagervej 28
Hviovre
2650
Denmark
+45 40824418
lhr@varix.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
26141788A
Study information
Scientific title
A three-arm, parallel group, randomised controlled trial of patients with small saphenous vein insufficiency treated with either endovascular laser, ultrasound-guided foam sclerotherapy, or conventional surgery
Acronym
Study hypothesis
Successful treatment of small saphenous varicose veins using laser, foam or surgery is equally possible, and will give a successful removal of insufficiency in 90% of patients treated.
Ethics approval
The local Danish ethics committee approved in April 2010
Study design
Multicentre three-arm randomised controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Small Saphenous vein varicose veins
Intervention
330 patients will be randomised to receive either:
1. Endovenous laser destruction of the short saphenous vein
2. Ultrasound-guided foam sclerotherapy of the short saphenous vein
3. Conventional surgical removal of the short saphenous vein
Follow up after 3 days, 1 month, 1 year, 3 years, and 5 years thereafter.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Amended as of 12/11/2010 to following:
1. Efficacy
2. Recurrent varicose veins
Initial information at time of registration:
1. Interruption of sensitivity and motor skills
2. Reflux equivalent to the inlet of Parva, more than 1,5cm from the inlet and distally equivalent to the treated part of Parva
3. Reflux equivalent to new vessels/perforants in the fossa poplitea
4. New varicose veins
5. Return to normal activities
6. Return to work
7. Use of pain tablets
8. Pain score (analogue scale 0-10), daily for the first 10 days
9. Additional venous treatments on the treated leg
Secondary outcome measures
Amended as of 12/11/2010 to following:
1. Interruption of sensitivity and motor skills
2. Reflux equivalent to the inlet of Parva, more than 1.5 cm from the inlet and distally equivalent to the treated part of Parva
3. Reflux equivalent to new vessels/perforants in the fossa poplitea
4. New varicose veins
5. Return to normal activities
6. Return to work
7. Use of pain tablets
8. Pain score (analogue scale 0 - 10), daily for the first 10 days
9. Additional venous treatments on the treated leg
Initial information at time of registration:
1. Intervention time from "skin to skin"
2. Number of phlebectomies
3. Small saphenous vein diameter 5 cm distal from the saphenopopliteal inlet
4. Aberdeen varicose veins symptoms severity score (AVVSS)
5. SF - 36 quality of life questionnaire
6. Venous severity score
7. Venous procedures on the treated leg
Overall trial start date
01/09/2010
Overall trial end date
01/09/2020
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age: 18-75
2. Informed approval
3. Varicose veins with symptoms, and reflux in Small Saphenous Vein defined as 0,5 seconds reflux after manual compression of the calf while standing
4. Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) classification C2-C4
5. Bilateral treatment is allowed when the same treatment is given to both legs during the same intervention
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
330
Participant exclusion criteria
1. Deep Venous Thrombosis (DVT) of the leg
2. Insufficient popliteal perforants
3. Previous varicose surgery in the popliteal area
4. Age under 18
5. Contradictions against use of Aethoxysklerol®
6. Great saphenous vein insuffienciency at the same time or surgery for Great Saphenous vein insufficiency < 3 months previously
7. History or foot-pulse indicating arterial insufficiency or/and ankle/arm index <0.9
8. Convoluted or disrupted Parva, that will make it inappropriate for the treatments
9. Other anatomical relations that will make surgery difficult
10. Pregnant or have given birth < 3 months previously
Recruitment start date
01/09/2010
Recruitment end date
01/09/2020
Locations
Countries of recruitment
Denmark, Sweden
Trial participating centre
Nordre Kystagervej 28
Hviovre
2650
Denmark
Sponsor information
Organisation
Åreknudeklinikken (Denmark)
Sponsor details
Eskadronsvej 4A
Naestved
4700
Denmark
-
lhr@varix.dk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Foundation of the National Health Security System (Fonden for faglig udvikling af speciallægepraksis) (Denmark)
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
Results - basic reporting
Publication summary