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Surgery or Noninvasive Therapy for Varicose Veins (Magna)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00529672
Recruitment Status : Unknown
Verified November 2010 by Erasmus Medical Center.
Recruitment status was:  Recruiting
First Posted : September 14, 2007
Last Update Posted : November 16, 2010
Sponsor:
Information provided by:

Study Description
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.

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

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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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : May 2007
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

Secondary Outcome Measures :
  1. treatment related adverse events and complications [ Time Frame: 3 months, 1 and 5 years ]
  2. patient reported outcomes (HRQOL and treatment satisfaction) [ Time Frame: 3 months, 1 and 5 years ]
  3. cost effectiveness analysis [ Time Frame: 3 months, 1 and 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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