Surgery or Noninvasive Therapy for Varicose Veins - Full Text View

Sponsor:	Erasmus Medical Center
Information provided by:	Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00529672

Purpose

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 sclerocompression therapy and endovenous laser therapy.

Condition	Intervention	Phase
Varicose Vein	Procedure: crossectomie and short stripping Procedure: ultrasound guided sclerocompression therapy Procedure: endovenous laser therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Unicenter Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerocompression Therapy With Foam and Endovenous Laser Therapy

Resource links provided by NLM:

MedlinePlus related topics: Surgery Ultrasound Varicose Veins

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:

anatomical succes rate (absence or obliteration of GSV on US examination) [ Time Frame: 3 months, 1 and 5 years ]

Secondary Outcome Measures:

treatment realted adverse events and complications [ Time Frame: 3 months, 1 and 5 years ]
patient reported outcomes (HRQOL and treatment satisfaction) [ Time Frame: 3 months, 1 and 5 years ]
cost effectiveness analysis [ Time Frame: 3 months, 1 and 5 years ]

Estimated Enrollment:	240
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2011

Arms	Assigned Interventions
1: Active Comparator Surgery: crossectomie plus short stripping	Procedure: crossectomie and short stripping under spinal or complete anaesthesia
2: Active Comparator ultrasound guided sclerocompression therapy with foam (3% polidaconal)	Procedure: ultrasound guided sclerocompression therapy 1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein>
3: Active Comparator Endovenous laser therapy (940 nm, about 70 J/cm)	Procedure: endovenous laser therapy 940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare will be used.

Hide Detailed Description

Detailed Description:

Inclusion criteria:

Ultrasound confirmed GSV insufficiency (reflux time >0.5 second and vein diameter ≥0.5 cm)
non-treated GSV variocoses
CEAP -classification > C2 and As2
>18 years old
Informed consent.

Exclusion criteria:

Acute venous thrombosis / flebitis
Agenesia of deep venous system
Vascular syndromes
Post-trombotic syndroom of occlusive type
Contra-indications for surgery

Primary outcomes:

1. anatomical succes 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 repiorted outcomes (HRQOL and treatment satisfaction)(after 3 monhts)
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: departmnent 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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

primary insufficient GSV objectived with US: reflux>0.5 sec and diameter>0.5cm)
non-treated varicose veins
>18 years
informed consent

Exclusion Criteria:

acute thrombosis or flebitis
agnesia of deep venous system
vascular syndromes
use of anticoagulantia
contraindications surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529672

Contacts

Contact: Michael Kockaert, MD	31 10 4634580	M.KOCKAERT@ERASMUSMC.NL
Contact: Tamar Nijsten, MD, PhD	31 10 4631019	t.nijsten@erasmusmc.nl

Locations

Netherlands
Erasmus MC dermatology	Recruiting
Rotterdam, Netherlands, 3000 CA
Contact: Michael Kockaert, MD 31 10 4634580 m.kockaert@erasmusmc.nl
Contact: Tamar Nijsten, MD, PhD 31 10 4631019 t.nijsten@ersmusmc.nl
Sub-Investigator: Prof. sambeek, MD, PhD

Sponsors and Collaborators

Erasmus Medical Center

Investigators

Principal Investigator:

Martino Neumann, MD, PhD

Erasmus MC

More Information

No publications provided

Study ID Numbers:	2005-325
Study First Received:	September 13, 2007
Last Updated:	September 17, 2007
ClinicalTrials.gov Identifier:	NCT00529672 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:

endovenous laser thearpy
sclerocompression therapy
crossectomie and stripping

surgery
treatment
varicose veins

Additional relevant MeSH terms:

Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 27, 2009