Comparison of Treatments in Venous Insufficiency

Not Applicable

Completed

• Conditions: Venous Insufficiency
• Interventions: Procedure: Laser ablation; Procedure: Operative treatment; Procedure: Foam sclerotherapy

• Registration Number: NCT01298908
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Primary Completion: 2012-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser ablation	Laser ablation	Ultrasound guided laser ablation
Operative treatment	Operative treatment	vein stripping
Foam sclerotherapy	Foam sclerotherapy	Ultrasound guided foam sclerotherapy

Primary Outcome Measures

Name	Time	Method
Recanalization or reflux of the treated venous trunk	at 1 and 12 months	Results will be verified by Duplex scanning

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Department of Vascular Surgery, Tampere University Hospital; 🇫🇮 Tampere, Finland

Department of Vascular Surgery, Helsinki University Central Hospital; 🇫🇮 Helsinki, HUS, Finland