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Surgery or Noninvasive Therapy for Varicose Veins (Magna)

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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:
Erasmus Medical Center

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

  Show Detailed Description

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

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.



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 ]


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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

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