FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins
FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study
2 other identifiers
interventional
460
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 6, 2010
CompletedFirst Posted
Study publicly available on registry
April 14, 2010
CompletedApril 14, 2010
April 1, 2010
3.8 years
April 6, 2010
April 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cumulative probability of recurrent varicose vein within 24 months after treatment
24 months
Secondary Outcomes (3)
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
Study Arms (2)
high ligation and stripping
ACTIVE COMPARATORsurgery consisting of high ligation in combination with long saphenous stripping
duplex guided foam sclerotherapy
ACTIVE COMPARATORduplex guided foam sclerotherapy
Interventions
surgery consisting of high ligation in combination with long saphenous stripping
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- active ulcer
- signs of deep venous thrombosis with duplex
- incompetence of the deep venous system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht UMC
Maastricht, Netherlands
Related Publications (1)
Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, van Neer P, vd Kley J, de Haan E, Sommer A. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012 Aug;99(8):1062-70. doi: 10.1002/bjs.8781. Epub 2012 May 25.
PMID: 22627969DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
A Sommer, MD PhD
Maastricht UMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 6, 2010
First Posted
April 14, 2010
Study Start
February 1, 2006
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
April 14, 2010
Record last verified: 2010-04