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FOAM-study veins.


- candidate number1959
- NTR NumberNTR654
- ISRCTNISRCTN74375188
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR31-jan-2006
- Secondary IDsN/A 
- Public TitleFOAM-study veins.
- Scientific TitleCost minimization study comparing surgery versus duplex guided foam sclerotherapy of varicose veins: a randomized controlled study.
- ACRONYMN/A
- hypothesisThe hypothesis underlying this study is that duplex guided foam sclerotherapy may be cost saving and is more acceptable for patients than ligation and stripping of the greater saphenous vein, because there is no need for anaesthesia and incisions and it is lecking several side-effects, such as scars, haematomas and a painful recovery period of at least 7 days known after surgical intervention.
- Healt Condition(s) or Problem(s) studiedHypoxia
- Inclusion criteria1. Primary trunkal varicositas of the GSV; 2. Age > 18 years; 3. Reflux>0.5 s and insufficiency of the SF-junction measured by duplex; 4. Reflux for at least 20 cm of the GSV in the upper leg; 5. Informed consent; 6. Normal deep venous system.
- Exclusion criteria1. Signs of DVT found with duplex; 2. Immobility; 3. Allergy for polidocanol in the past; 4. Life-expectation < 3 years; 5. Pregnancy; 6. Abnormal Deep Venous System; 7. Active ulcus cruris.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-feb-2006
- planned closingdate1-mrt-2009
- Target number of participants460
- Interventions1. Standardized duplex guided foam sclerotherapy; 2. Standardized surgery procedure.
- Primary outcomeCumulative probability of recurrent varicose vein at 18-24 months after treatment.
- Secondary outcome1. Quality of life (EuroQol-5D); 2. Patient preference; 3. Social costs.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. N.H. Shadid
- CONTACT for SCIENTIFIC QUERIESMD. N.H. Shadid
- Sponsor/Initiator Academic Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryVaricose veins in the legs is a common health problem. Ten percent of the population needs medical intervention. It causes high health care costs.Nowadays treatment modalities include surgery and duplex guided foam sclerothrapy. Both treatments are equally effective in terms of recurrences, however some studies indicate superiority of surgery and other studies indicating superiority of scelrotherapy. Costs associated with both treatments and patient preferences have never been studied. There is a need for a well-designed study comparing the effectiveness, the costs and patient acceptability and minimizing costs. The hypothesis underlying this study is that duplex guided foam sclerotherapy may be cost saving and is more acceptable for patients, because there is no need for anaesthesia and incisions and it is without side-effects, such as scars, haemotomas and a painful recovery period of at least 7 days. We designed a randomized controlled trial, the number of patients needed per group is estimated to be n=230. The primary outcome measure is the cumulative probability of recurrent varicose vein within 24 months after treatment. Secondary outcome measures are quality of life(as measured by EuroQol-5D), patient preferences(as measured by cojoint analysis) and costs. Cost-minimization analysis with potentially cost savings of 339.328 euros per year for the adherence(=target) population of the University Hospital of Maastricht. The study will take approximately 36 months in total.
- Main changes (audit trail)
- RECORD31-jan-2006 - 3-jul-2006


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