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Surgery or Noninvasive Therapy for Varicose Veins (Magna)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Erasmus Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Erasmus Medical Center Identifier:
First received: September 13, 2007
Last updated: November 15, 2010
Last verified: November 2010
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.

Condition Intervention Phase
Varicose Vein Procedure: crossectomy and short stripping Procedure: ultrasound guided sclerotherapy with foam Procedure: endovenous laser therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Erasmus Medical Center:

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

Secondary Outcome Measures:
  • treatment related 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
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Surgery: crossectomy plus short stripping
Procedure: crossectomy and short stripping
under spinal or complete anaesthesia
Active Comparator: 2
ultrasound guided sclerotherapy with foam (3% polidocanol)
Procedure: ultrasound guided sclerotherapy with foam
1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein>
Active Comparator: 3
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 (registered) 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 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


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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00529672

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

Erasmus MC dermatology Recruiting
Rotterdam, Netherlands, 3000 CA
Contact: Michael Kockaert, MD    31 10 4634580   
Contact: Tamar Nijsten, MD, PhD    31 10 4631019   
Sub-Investigator: Prof. sambeek, MD, PhD         
Sponsors and Collaborators
Erasmus Medical Center
Principal Investigator: Martino Neumann, MD, PhD Erasmus MC
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. TEC Nijsten, Erasmus MC Identifier: NCT00529672     History of Changes
Other Study ID Numbers: 2005-325
Study First Received: September 13, 2007
Last Updated: November 15, 2010

Keywords provided by Erasmus Medical Center:
endovenous laser therapy
crossectomy and stripping
varicose veins

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases processed this record on July 25, 2017