Surgery or Noninvasive Therapy for Varicose Veins

Phase 3

• Conditions: Varicose Vein
• Interventions: Procedure: crossectomy and short stripping; Procedure: ultrasound guided sclerotherapy with foam; Procedure: endovenous laser therapy

• Registration Number: NCT00529672
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-13
• Study First Posted: 2007-09-14
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-15
• Last Update Posted: 2010-11-16
• Primary Completion: 2011-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	crossectomy and short stripping	Surgery: crossectomy plus short stripping
2	ultrasound guided sclerotherapy with foam	ultrasound guided sclerotherapy with foam (3% polidocanol)
3	endovenous laser therapy	Endovenous laser therapy (940 nm, about 70 J/cm)

Primary Outcome Measures

Name	Time	Method
anatomical success rate (absence or obliteration of GSV on US examination)	3 months, 1 and 5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Erasmus MC dermatology; 🇳🇱 Rotterdam, Netherlands