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

Not Applicable

Completed

• Conditions: Varicose Vein Disease
• Interventions: Procedure: high ligation and stripping (surgery); Procedure: FOAM

• Registration Number: NCT01103258
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2010-04
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-12
• Last Update Submitted: 2010-04-12
• Study First Posted: 2010-04-14
• Last Update Posted: 2010-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high ligation and stripping	high ligation and stripping (surgery)	surgery consisting of high ligation in combination with long saphenous stripping
duplex guided foam sclerotherapy	FOAM	duplex guided foam sclerotherapy

Primary Outcome Measures

Name	Time	Method
cumulative probability of recurrent varicose vein within 24 months after treatment	24 months

Secondary Outcome Measures

Name	Time	Method
quality of life (as measured by EuroQol-5D)	24 months
patient preferences (as measured by conjoint analysis)	24 months
direct Health care costs	24 months	materials, operation costs, personnel costs

Trial Locations

Locations (1)

Maastricht UMC; 🇳🇱 Maastricht, Netherlands