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Sponsored by: |
Erasmus Medical Center |
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Information provided by: | Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT00529672 |
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 |
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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 |
Estimated Enrollment: | 240 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2011 |
Arms | Assigned Interventions |
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1: Active Comparator
Surgery: crossectomie plus short stripping
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Procedure: crossectomie and short stripping
under spinal or complete anaesthesia
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2: Active Comparator
ultrasound guided sclerocompression therapy with foam (3% polidaconal)
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Procedure: ultrasound guided sclerocompression therapy
1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein>
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3: Active Comparator
Endovenous laser therapy (940 nm, about 70 J/cm)
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Procedure: endovenous laser therapy
940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare will be used.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Kockaert, MD | 31 10 4634580 | M.KOCKAERT@ERASMUSMC.NL |
Contact: Tamar Nijsten, MD, PhD | 31 10 4631019 | t.nijsten@erasmusmc.nl |
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 |
Principal Investigator: | Martino Neumann, MD, PhD | Erasmus MC |
Study ID Numbers: | 2005-325 |
Study First Received: | September 13, 2007 |
Last Updated: | September 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00529672 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
endovenous laser thearpy sclerocompression therapy crossectomie and stripping |
surgery treatment varicose veins |
Varicose Veins Vascular Diseases Polidocanol |
Cardiovascular Diseases |