Clinical trial NCT00529672: Surgery or Noninvasive Therapy for Varicose Veins
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Varicose Vein
Keywords: endovenous laser therapy
sclerotherapy
crossectomy and stripping
surgery
treatment
varicose veins
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: anatomical success rate (absence or obliteration of GSV on US examination)
timeFrame: 3 months, 1 and 5 years
Secondary outcomes:
measure: treatment related adverse events and complications
timeFrame: 3 months, 1 and 5 years
measure: patient reported outcomes (HRQOL and treatment satisfaction)
timeFrame: 3 months, 1 and 5 years
measure: cost effectiveness analysis
timeFrame: 3 months, 1 and 5 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC dermatology
Study officials:
affiliation: Erasmus Medical Center
name: Martino Neumann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Velden SK, Biemans AA, De Maeseneer MG, Kockaert MA, Cuypers PW, Hollestein LM, Neumann HA, Nijsten T, van den Bos RR. Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. Br J Surg. 2015 Sep;102(10):1184-94. doi: 10.1002/bjs.9867. Epub 2015 Jul 1.
citation: Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.