Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2003/190
Study information
Scientific title
A randomised controlled trial of Radiofrequency Ablation of the long saphenous vein versus Conventional Saphenofemoral disconnection and stripping in the treatment of varicose veins
Acronym
RACS
Study hypothesis
Radiofrequency ablation has the potential to improve the outcome of patients undergoing surgical treatment for varicose veins due to superficial venous incompetence.
Ethics approval
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).
Study design
Randomised controlled trial using web-based method
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Varicose veins of lower limbs
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
01/04/2004
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Associated short saphenous and deep vein incompetence
2. Pregnancy
3. Patients with pacemaker or defibrillator
Recruitment start date
01/04/2004
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Vascular Surgeon
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Organisation
VNUS Medical Technologies UK Ltd (UK)
Sponsor details
Kenneth Dibben House
Enterprise Road
Southampton Science Park
Chilworth
Hampshire
SO16 7NS
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
VNUS Medical Technologies UK Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19879166
Publication citations
-
Results
Subramonia S, Lees T, Radiofrequency ablation vs conventional surgery for varicose veins - a comparison of treatment costs in a randomised trial., Eur J Vasc Endovasc Surg, 2010, 39, 1, 104-111, doi: 10.1016/j.ejvs.2009.09.012.