Venous Insufficiency
Conditions
Keywords
varicose veins, oedema
Brief summary
Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers. The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.
Detailed description
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.
Interventions
PROCEDUREOperative treatment
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.
PROCEDURELaser ablation
In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein.
PROCEDUREFoam sclerotherapy
Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control.
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients with chronic superficial vein insufficiency * patient must be 20-70 years old * degree of difficulty of vein insufficiency C2-C4 * average diameter of refluxing great saphenous vein 4 -10 mm * patient is agreeable to the study
Exclusion criteria
* peripheral atherosclerotic occlusive disease * lymphoedema * severe concomitant disease * venous ulcers or unclassified skin changes * BMI more than 40 * pregnancy * allergy to the foam used in sclerotherapy or to local anaesthetics * coagulation disorder * bilateral vein insufficiency (equal symptoms)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recanalization or reflux of the treated venous trunk | at 1 and 12 months | Results will be verified by Duplex scanning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom relief | at 1 and 12 months | Symptoms will be evaluated by using CEAP-classification and degree of disability |
| Complications related to procedure | at 1 and 12 months | At 1 month follow-up immediate complications will be recorded. At 12 months follow-up appearance of late complications and pain and incapacity for work due to the procedure will be recorded. |
| Quality of life | at 1 and 12 months | Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life) |
Countries
Finland
Outcome results
None listed