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11 February 2012
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| [ Print-friendly version ] |
| Comparing endovascular laser, ultrasound guided foam sclerotherapy, and conventional surgery for the treatment of small saphenous varicose veins |
| ISRCTN | ISRCTN91735422 |
| ClinicalTrials.gov identifier | |
| Public title | Comparing endovascular laser, ultrasound guided foam sclerotherapy, and conventional surgery for the treatment of small saphenous varicose veins |
| Scientific title | A 3 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 | N/A |
| Serial number at source | 26141788A |
| Study hypothesis | Succesfull treatment of small saphenous varicose veins using laser, foam or surgery is equally possible, and will give a succesfull removal of insufficiency in 90% of patients treated. |
| Lay summary | Not provided at time of registration |
| Ethics approval | The local Danish ethics committee approved in April 2010 |
| Study design | Multicentre 3 arm randomised controlled parallel group trial |
| Countries of recruitment | Denmark, Sweden |
| Disease/condition/study domain | Small Saphenous vein varicose veins |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/09/2010 |
| Anticipated end date | 01/09/2020 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | 330 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Foundation of the National Health Security System (Fonden for faglig udvikling af speciallægepraksis) (Denmark) |
| Trial website | |
| Publications | |
| Contact name | Dr Lars H. Rasmussen |
| Address | Nordre Kystagervej 28 |
| City/town | Hviovre |
| Zip/Postcode | 2650 |
| Country | Denmark |
| Tel | +45 40824418 |
| lhr@varix.dk | |
| Sponsor | Åreknudeklinikken (Denmark) |
| Address | Eskadronsvej 4A |
| City/town | Naestved |
| Zip/Postcode | 4700 |
| Country | Denmark |
| lhr@varix.dk | |
| Date applied | 28/06/2010 |
| Last edited | 07/09/2011 |
| Date ISRCTN assigned | 08/07/2010 |
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