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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Varicose Vein Disease

Treatments: Procedure: high ligation and stripping (surgery); Procedure: FOAM

Study type: Interventional

Funder types: Other

Identifiers

NCT01103258

MEC 05-2-014

ZON MW 4636 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 460 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

460 participants in 2 patient groups

high ligation and stripping

Active Comparator group

Description:

surgery consisting of high ligation in combination with long saphenous stripping

Treatment:

Procedure: high ligation and stripping (surgery)

duplex guided foam sclerotherapy

Active Comparator group

Description:

duplex guided foam sclerotherapy

Treatment:

Procedure: FOAM