Comparing endovascular laser, ultrasound-guided foam sclerotherapy, and conventional surgery for the treatment of small saphenous varicose veins
| ISRCTN | ISRCTN91735422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91735422 |
| Secondary identifying numbers | 26141788A |
- Submission date
- 28/06/2010
- Registration date
- 08/07/2010
- Last edited
- 24/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Nordre Kystagervej 28
Hviovre
2650
Denmark
| Phone | +45 40824418 |
|---|---|
| lhr@varix.dk |
Study information
| Study design | Multicentre three-arm randomised controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | The local Danish ethics committee approved in April 2010 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2010 |
| Completion date | 01/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 330 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 01/09/2020 |
Locations
Countries of recruitment
- Denmark
- Sweden
Study participating centre
2650
Denmark
Sponsor information
Hospital/treatment centre
Eskadronsvej 4A
Naestved
4700
Denmark
| lhr@varix.dk |
Funders
Funder type
Government
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 |
Editorial Notes
24/06/2016: Plain English summary added.
