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FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins

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ClinicalTrials.gov Identifier: NCT01103258
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : April 14, 2010
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Maastricht University Medical Center

Study Description
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Brief Summary:

Varicose vein disease is a common health problem, which causes much discomfort to patients.

Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population.

Choice of treatment often depends on the referral preference of the General Practitioner. Until now data are missing which treatment is more cost effective. The current proposal aims at comparing the effects, costs and patient preferences between duplex guided foam sclerotherapy and surgery in the treatment of greater varicose veins.


Condition or disease Intervention/treatment Phase
Varicose Vein Disease Procedure: high ligation and stripping (surgery) Procedure: FOAM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study
Study Start Date : February 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: high ligation and stripping
surgery consisting of high ligation in combination with long saphenous stripping
 Procedure: high ligation and stripping (surgery)
surgery consisting of high ligation in combination with long saphenous stripping
Active Comparator: duplex guided foam sclerotherapy
duplex guided foam sclerotherapy
 Procedure: FOAM
duplex guided foam sclerotherapy


Outcome Measures
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Primary Outcome Measures :
  1. cumulative probability of recurrent varicose vein within 24 months after treatment [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. quality of life (as measured by EuroQol-5D) [ Time Frame: 24 months ]
  2. patient preferences (as measured by conjoint analysis) [ Time Frame: 24 months ]
  3. direct Health care costs [ Time Frame: 24 months ]
    materials, operation costs, personnel costs


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • incompetence of great saphenous vein for minimal 20 cm
  • life expectancy at least 3 years
  • open and competent deep venous system
  • willing to undergo both treatments

Exclusion Criteria:

  • active ulcer
  • signs of deep venous thrombosis with duplex
  • incompetence of the deep venous system
Contacts and Locations
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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): NCT01103258


Locations
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Netherlands
Maastricht UMC
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Study Director: A Sommer, MD PhD Maastricht UMC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr A Sommer, Maastricht UMC
ClinicalTrials.gov Identifier: NCT01103258    
Other Study ID Numbers: MEC 05-2-014
ZON MW 4636 ( Other Grant/Funding Number: ZON MW )
First Posted: April 14, 2010    Key Record Dates
Last Update Posted: April 14, 2010
Last Verified: April 2010
Keywords provided by Maastricht University Medical Center:
Incompetence of the great saphenous vein.
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases