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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Varicose Vein Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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high ligation and stripping

surgery consisting of high ligation in combination with long saphenous stripping

Group Type ACTIVE_COMPARATOR

high ligation and stripping (surgery)

Intervention Type PROCEDURE

surgery consisting of high ligation in combination with long saphenous stripping

duplex guided foam sclerotherapy

Group Type ACTIVE_COMPARATOR

FOAM

Intervention Type PROCEDURE

duplex guided foam sclerotherapy

Interventions

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high ligation and stripping (surgery)

surgery consisting of high ligation in combination with long saphenous stripping

Intervention Type PROCEDURE

FOAM

duplex guided foam sclerotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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