Comparison of Treatments in Venous Insufficiency

Helsinki University Central Hospital231 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

231

Conditions

Venous Insufficiency

Interventions

Operative treatmentPROCEDURE

In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.

Laser ablationPROCEDURE

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.

Foam sclerotherapyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (2)

Department of Vascular Surgery, Helsinki University Central Hospital

Helsinki, HUS, Finland

Department of Vascular Surgery, Tampere University Hospital

Tampere, Finland

Outcomes

Primary Outcomes

Recanalization or reflux of the treated venous trunk

Results will be verified by Duplex scanning

Time frame: at 1 and 12 months

Secondary Outcomes

Symptom relief

Symptoms will be evaluated by using CEAP-classification and degree of disability

Time frame: at 1 and 12 months

Complications related to procedure

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.

Time frame: at 1 and 12 months

Quality of life

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)

Time frame: at 1 and 12 months

Data from ClinicalTrials.gov

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