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ISRCTN
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ISRCTN29015169
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ClinicalTrials.gov identifier
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Public title
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Vein ablation versus conventional surgery for varicose veins
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Scientific title
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A randomised controlled trial of Radiofrequency Ablation of the long saphenous vein versus Conventional Saphenofemoral disconnection and stripping in the treatment of varicose veins
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Acronym
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RACS
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Serial number at source
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2003/190
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Study hypothesis
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Radiofrequency ablation has the potential to improve the outcome of patients undergoing surgical treatment for varicose veins due to superficial venous incompetence.
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Ethics approval
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Ethics approval received from the Newcastle and North Tyneside Local Research Ethics Committees on the 1st December 2003. Please note that the sponsor and funder of the trial at the time of ethics approval was Mantis Surgical Ltd (UK).
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Study design
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Randomised controlled trial using web-based method
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Varicose veins of lower limbs
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Participants - inclusion criteria
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1. Patients aged 18 - 70 years, both sexes
2. Varicose veins due to isolated long saphenous vein incompetence proven on duplex scan
3. Requiring surgery
4. Long saphenous vein suitable for radiofrequency ablation
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Participants - exclusion criteria
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1. Associated short saphenous and deep vein incompetence
2. Pregnancy
3. Patients with pacemaker or defibrillator
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Anticipated start date
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01/04/2004
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Anticipated end date
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31/12/2010
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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100
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Interventions
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1. Radiofrequency ablation
2. Conventional saphenofemoral disconnetion and stripping
Both procedures are to be performed under general anaesthetic during a single operation. Based on their allocation patients would either receive radiofrequency ablation of their long saphenous vein or stripping of their long saphenous vein. Both groups will undergo multiple stab avulsions or phlebectomies as deemed necessary to complete the operation in the same setting. Both groups are expected to be followed up for five years.
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Primary outcome measure(s)
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Elimination of long saphenous vein reflux and elimination of truncal varicosities. Measurement of outcomes will be carried out at the end of one week, six weeks, one year and five years.
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Secondary outcome measure(s)
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1. Time to return to normal activities and work
2. Quality of life, estimated using Aberdeen Varicose Vein Questionnaire, Venous Insufficiency Epidemiologic and Economic Study of Quality-of-Life and Symptoms (VEINES-QOL/Sym) questionnaire, 36-item short form health survey (SF-36) and EuroQOL-5D generic questionnaires
Measurement of outcomes will be carried out at the end of one week, six weeks, one year and five years.
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Sources of funding
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VNUS Medical Technologies UK Ltd (UK)
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Trial website
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Publications
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Contact name
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Mr
Tim
Lees
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Address
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Consultant Vascular Surgeon
Northern Vascular Centre
Freeman Hospital
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE7 7DN
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Country
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United Kingdom
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Sponsor
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VNUS Medical Technologies UK Ltd (UK)
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Address
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Kenneth Dibben House
Enterprise Road
Southampton Science Park
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City/town
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Chilworth, Hampshire
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Zip/Postcode
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SO16 7NS
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Country
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United Kingdom
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Sponsor website:
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http://www.vnus.com/uk
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Date applied
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08/11/2007
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Last edited
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05/02/2008
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Date ISRCTN assigned
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05/02/2008
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