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Surgery or Noninvasive Therapy for Varicose Veins (Magna)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Erasmus Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00529672
First received: September 13, 2007
Last updated: November 15, 2010
Last verified: November 2010

September 13, 2007
November 15, 2010
May 2007
May 2011   (final data collection date for primary outcome measure)
anatomical success rate (absence or obliteration of GSV on US examination) [ Time Frame: 3 months, 1 and 5 years ] [ Designated as safety issue: No ]
anatomical succes rate (absence or obliteration of GSV on US examination) [ Time Frame: 3 months, 1 and 5 years ]
Complete list of historical versions of study NCT00529672 on ClinicalTrials.gov Archive Site
  • treatment related adverse events and complications [ Time Frame: 3 months, 1 and 5 years ] [ Designated as safety issue: Yes ]
  • patient reported outcomes (HRQOL and treatment satisfaction) [ Time Frame: 3 months, 1 and 5 years ] [ Designated as safety issue: No ]
  • cost effectiveness analysis [ Time Frame: 3 months, 1 and 5 years ] [ Designated as safety issue: No ]
1. treatment realted adverse events and complications 2. patient reported outcomes (HRQOL and treatment satisfaction) 3. cost effectiveness analysis [ Time Frame: 3 months, 1 and 5 years ]
Not Provided
Not Provided
 
Surgery or Noninvasive Therapy for Varicose Veins
Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Varicose Vein
  • Procedure: crossectomy and short stripping
    under spinal or complete anaesthesia
  • Procedure: ultrasound guided sclerotherapy with foam
    1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein>
  • Procedure: endovenous laser therapy
    940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used.
  • Active Comparator: 1
    Surgery: crossectomy plus short stripping
    Intervention: Procedure: crossectomy and short stripping
  • Active Comparator: 2
    ultrasound guided sclerotherapy with foam (3% polidocanol)
    Intervention: Procedure: ultrasound guided sclerotherapy with foam
  • Active Comparator: 3
    Endovenous laser therapy (940 nm, about 70 J/cm)
    Intervention: Procedure: endovenous laser therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Michael Kockaert, MD 31 10 4634580 M.KOCKAERT@ERASMUSMC.NL
Contact: Tamar Nijsten, MD, PhD 31 10 4631019 t.nijsten@erasmusmc.nl
Netherlands
 
NCT00529672
2005-325
No
Dr. TEC Nijsten, Erasmus MC
Erasmus Medical Center
Not Provided
Principal Investigator: Martino Neumann, MD, PhD Erasmus MC
Erasmus Medical Center
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP