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OpenTrials
Completed

NCT Number: NCT01103258

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

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.

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Key information

Conditions

Varicose Vein Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht UMC

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high ligation and stripping (surgery)

Procedure

surgery consisting of high ligation in combination with long saphenous stripping

FOAM

Procedure

duplex guided foam sclerotherapy

Primary outcomes

  1. cumulative probability of recurrent varicose vein within 24 months after treatment

    Time frame: 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Apr 14, 2010
Registry last updated
Apr 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.