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

Varicose Vein Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103258
• Other study ID #: MEC 05-2-014
• Secondary ID: ZON MW 4636
• Status: Completed
• Phase: N/A
• First received: April 6, 2010
• Last updated: April 12, 2010
• Start date: February 2006
• Est. completion date: January 2010

Study information

• Verified date: April 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicose Vein Disease
• Varicose Veins

Intervention

Procedure:
• high ligation and stripping (surgery)
surgery consisting of high ligation in combination with long saphenous stripping
• FOAM
duplex guided foam sclerotherapy

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative probability of recurrent varicose vein within 24 months after treatment		24 months	No
Secondary	quality of life (as measured by EuroQol-5D)		24 months	No
Secondary	patient preferences (as measured by conjoint analysis)		24 months	No
Secondary	direct Health care costs	materials, operation costs, personnel costs	24 months	No