Comparison of Treatments in Venous Insufficiency

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Venous Insufficiency

Treatments: Procedure: Laser ablation; Procedure: Operative treatment; Procedure: Foam sclerotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01298908

Version 1.0 - Sep 6th, 2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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231 participants in 3 patient groups

Operative treatment

Other group

Description:

vein stripping

Treatment:

Procedure: Operative treatment

Laser ablation

Other group

Description:

Ultrasound guided laser ablation

Treatment:

Procedure: Laser ablation

Foam sclerotherapy

Other group

Description:

Ultrasound guided foam sclerotherapy

Treatment:

Procedure: Foam sclerotherapy