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ISRCTN
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ISRCTN74375188
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ClinicalTrials.gov identifier
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Public title
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FOAM-study veins: cost minimisation study comparing surgery versus duplex guided foam sclerotherapy of varicose veins - a randomised controlled study
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Scientific title
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Acronym
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N/A
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Serial number at source
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NTR654
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Study hypothesis
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The underlining hypothesis of this study is that duplex guided foam sclerotherapy may save costs and be more acceptable for patients than ligation and stripping of the greater saphenous vein, because there is no need for anaesthesia and incisions and it lacks several side-effects, such as scars, haematomas and a painful recovery period of at least 7 days known after surgical intervention.
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Multicentre, randomised, active controlled, parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Varicose veins
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Participants - inclusion criteria
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1. Primary truncal varicosities of the greater saphenous vein (GSV)
2. Aged greater than 18 years
3. Reflux greater than 0.5 seconds and insufficiency of the sapheno-femoral (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
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Participants - exclusion criteria
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1. Signs of deep vein thrombosis (DVT) found with duplex
2. Immobility
3. Allergy for polidocanol in the past
4. Life-expectancy less than 3 years
5. Pregnancy
6. Abnormal deep venous system
7. Active ulcus cruris
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Anticipated start date
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01/02/2006
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Anticipated end date
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01/03/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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460
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Interventions
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1. Standardised duplex guided foam sclerotherapy
2. Standardised surgery procedure
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Primary outcome measure(s)
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Cumulative probability of recurrent varicose vein at 18 - 24 months after treatment.
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Secondary outcome measure(s)
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1. Quality of life (EuroQol-5D)
2. Patient preference
3. Social costs
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
N.H.
Shadid
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Address
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Academic Hospital Maastricht (AZM)
P.O. Box 5800
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City/town
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Maastricht
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Zip/Postcode
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6202 AZ
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Country
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Netherlands
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Tel
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+31 (0)43 3876543
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Email
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nsh@sder.azm.nl
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Sponsor
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Academic Hospital Maastricht (AZM) (The Netherlands)
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Address
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P.O. Box 5800
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City/town
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Maastricht
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Zip/Postcode
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6202 AZ
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Country
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Netherlands
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Tel
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+31 (0)43 3876543
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Fax
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+31 (0)43 3877878
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Email
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info@azm.nl
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Date applied
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07/06/2006
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Last edited
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17/09/2008
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Date ISRCTN assigned
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07/06/2006
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