Back to resultsFOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins
Primary Purpose
Varicose Vein Disease
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
high ligation and stripping (surgery)
FOAM
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Vein Disease focused on measuring Incompetence of the great saphenous vein.
Eligibility Criteria
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
Sites / Locations
- Maastricht UMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
high ligation and stripping
duplex guided foam sclerotherapy
Arm Description
surgery consisting of high ligation in combination with long saphenous stripping
duplex guided foam sclerotherapy
Outcomes
Primary Outcome Measures
cumulative probability of recurrent varicose vein within 24 months after treatment
Secondary Outcome Measures
quality of life (as measured by EuroQol-5D)
patient preferences (as measured by conjoint analysis)
direct Health care costs
materials, operation costs, personnel costs
Full Information
NCT ID
NCT01103258
First Posted
April 6, 2010
Last Updated
April 12, 2010
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01103258
Brief Title
FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins
Official Title
FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Vein Disease
Keywords
Incompetence of the great saphenous vein.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high ligation and stripping
Arm Type
Active Comparator
Arm Description
surgery consisting of high ligation in combination with long saphenous stripping
Arm Title
duplex guided foam sclerotherapy
Arm Type
Active Comparator
Arm Description
duplex guided foam sclerotherapy
Intervention Type
Procedure
Intervention Name(s)
high ligation and stripping (surgery)
Intervention Description
surgery consisting of high ligation in combination with long saphenous stripping
Intervention Type
Procedure
Intervention Name(s)
FOAM
Intervention Description
duplex guided foam sclerotherapy
Primary Outcome Measure Information:
Title
cumulative probability of recurrent varicose vein within 24 months after treatment
Time Frame
24 months
Secondary Outcome Measure Information:
Title
quality of life (as measured by EuroQol-5D)
Time Frame
24 months
Title
patient preferences (as measured by conjoint analysis)
Time Frame
24 months
Title
direct Health care costs
Description
materials, operation costs, personnel costs
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Sommer, MD PhD
Organizational Affiliation
Maastricht UMC
Official's Role
Study Director
Facility Information:
Facility Name
Maastricht UMC
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
22627969
Citation
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.
Results Reference
derived
Learn more about this trial
FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins
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