Surgery or Noninvasive Therapy for Varicose Veins

Varicose Vein Clinical Trial

— Magna  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00529672
• Other study ID #: 2005-325
• Status: Recruiting
• Phase: Phase 3
• First received: September 13, 2007
• Last updated: November 15, 2010
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: November 2010
• Source: Erasmus Medical Center
• Contact: Michael Kockaert, MD
• Phone: 31 10 4634580
• Email: M.KOCKAERT[@]ERASMUSMC.NL
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. treatment induced adverse events and complications (after 3 months)

2. patient reported outcomes (HRQOL and treatment satisfaction)(after 3 months)

3. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicose Vein
• Varicose Veins

Intervention

Procedure:
• crossectomy and short stripping
under spinal or complete anaesthesia
• ultrasound guided sclerotherapy with foam
1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein>
• endovenous laser therapy
940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used.

Locations

Country	Name	City	State
Netherlands	Erasmus MC dermatology	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anatomical success rate (absence or obliteration of GSV on US examination)		3 months, 1 and 5 years	No
Secondary	treatment related adverse events and complications		3 months, 1 and 5 years	Yes
Secondary	patient reported outcomes (HRQOL and treatment satisfaction)		3 months, 1 and 5 years	No
Secondary	cost effectiveness analysis		3 months, 1 and 5 years	No