Surgery or Noninvasive Therapy for Varicose Veins

Study Overview
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Brief Summary
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For more than 100 years, surgery has been the standard of care of varicose veins of the legs. The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively high recurrence rate in the long term (up to 40%). In the last decade, several new techniques have become available but they have not yet been compared to surgery. This trail will evaluate the effectiveness, patients' perspective and cost effectiveness of surgery and non-invasive techniques such as ultrasound guided sclerotherapy with foam and endovenous laser therapy.

Detailed Description
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Inclusion criteria: Ultrasound confirmed GSV insufficiency (reflux time >0.5 second and vein diameter ≥0.5 cm) non-treated GSV varicosis CEAP -classification > C2 and As2 >18 years old Informed consent. Exclusion criteria: Acute venous thrombosis / phlebitis Absence of deep venous system Vascular syndromes Post-thrombotic syndrome of occlusive type Contra-indications for surgery use of anticoagulants Primary outcomes: 1. anatomical success using US (absence of GSV or flow) (at 3 months, 1 and 5 year) Secondary outcomes: treatment induced adverse events and complications (after 3 months) patient reported outcomes (HRQOL and treatment satisfaction)(after 3 months) cost effectiveness analyses (after 1 and 5 years) Included patients: total of 240 (80 per arm) Study start: May 2007 (recruitment ongoing) Study completion: May 2011 Follow up after 3 months, 1, 2, 3, 4 and 5 years Location: department of dermatology, Erasmus MC, Rotterdam, The Netherlands Principle investigators: M. Kockaert, T. Nijsten & M. Neumann Publications: Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J Vasc Surg. 2007 Aug;46(2):308-15. Epub 2007 Jun 27. Sharif MA, Lau LL, Lee B, Hannon RJ, Soong CV. Role of endovenous laser treatment in the management of chronic venous insufficiency. Ann Vasc Surg. 2007 Sep;21(5):551-5. Mundy L, Merlin TL, Fitridge RA, Hiller JE. Systematic review of endovenous laser treatment for varicose veins. Br J Surg. 2005 Oct;92(10):1189-94. Jia X, Mowatt G, Burr JM, Cassar K, Cook J, Fraser C.Systematic review of foam sclerotherapy for varicose veins. Br J Surg. 2007 Aug;94(8):925-36. Subramonia S, Lees TA.The treatment of varicose veins.Ann R Coll Surg Engl. 2007 Mar;89(2):96-100. Bohler K. Varicose veins: disfigurement or disease? Herz. 2007 Feb;32(1):18-25. Bamigboye AA, Smyth R. Interventions for varicose veins and leg oedema in pregnancy. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001066. van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. New endovenous therapies of truncal varicosities are more effective than surgical stripping and sclerotherapy: meta-analysis and meta-regression. Lancet, Submitted

Official Title
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Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy

Conditions
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Varicose Vein

Intervention / Treatment
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* Procedure: crossectomy and short stripping
* Procedure: ultrasound guided sclerotherapy with foam
* Procedure: endovenous laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary insufficient GSV confirmed by US: reflux>0.5 sec and diameter>0.5cm. non-treated insufficient GSV >18 years informed consent Exclusion Criteria: acute thrombosis or phlebitis absence of deep venous system vascular syndromes use of anticoagulants contraindications surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Surgery: crossectomy plus short stripping | Procedure: crossectomy and short stripping<br>* under spinal or complete anaesthesia<br>|
| Active Comparator: 2<br>ultrasound guided sclerotherapy with foam (3% polidocanol) | Procedure: ultrasound guided sclerotherapy with foam<br>* 1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein><br>|
| Active Comparator: 3<br>Endovenous laser therapy (940 nm, about 70 J/cm) | Procedure: endovenous laser therapy<br>* 940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomical success rate (absence or obliteration of GSV on US examination) |  | 3 months, 1 and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment related adverse events and complications |  | 3 months, 1 and 5 years | 
| patient reported outcomes (HRQOL and treatment satisfaction) |  | 3 months, 1 and 5 years | 
| cost effectiveness analysis |  | 3 months, 1 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, endovenous laser therapy, sclerotherapy, crossectomy and stripping, treatment, varicose veins