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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00529672 |
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Date of registration:
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13/09/2007 |
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Primary sponsor: |
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Public title:
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Surgery or Noninvasive Therapy for Varicose Veins
Magna |
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Scientific title:
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Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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240 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00529672 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Michael Kockaert, MD |
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Address:
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Telephone:
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31 10 4634580 |
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Email:
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m.kockaert@erasmusmc.nl |
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Affiliation:
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Name:
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Michael Kockaert, MD |
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Address:
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Telephone:
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31 10 4634580 |
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Email:
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M.KOCKAERT@ERASMUSMC.NL |
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Affiliation:
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Name:
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Martino Neumann, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Erasmus MC |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Varicose Vein
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Intervention(s)
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Procedure: crossectomy and short stripping
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Procedure: endovenous laser therapy
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Procedure: ultrasound guided sclerotherapy with foam
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Primary Outcome(s)
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anatomical success rate (absence or obliteration of GSV on US examination)
[Time Frame: 3 months, 1 and 5 years]
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Secondary Outcome(s)
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cost effectiveness analysis
[Time Frame: 3 months, 1 and 5 years]
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patient reported outcomes (HRQOL and treatment satisfaction)
[Time Frame: 3 months, 1 and 5 years]
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treatment related adverse events and complications
[Time Frame: 3 months, 1 and 5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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