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Completed

NCT Number: NCT01298908

Comparison of Treatments in Venous Insufficiency

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.

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Key information

Conditions

Venous Insufficiency Cardiovascular Diseases Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms Varicose Veins Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Vascular Surgery, Helsinki University Central Hospital, Helsinki, HUS, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Operative treatment

Procedure

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

Other names: Vein stripping

Laser ablation

Procedure

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.

Other names: Ultrasound guided laser ablation

Foam sclerotherapy

Procedure

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.

Other names: Ultrasound guided foam sclerotherapy

Primary outcomes

  1. Recanalization or reflux of the treated venous trunk

    Time frame: at 1 and 12 months

    Results will be verified by Duplex scanning

Secondary outcomes

  1. Symptom relief

    Time frame: at 1 and 12 months

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

  2. Complications related to procedure

    Time frame: 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.

  3. Quality of life

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency

Important dates

Study start
2007
Primary completion
2012
Study completion
2015
First posted
Feb 18, 2011
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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