Contact information
Type
Scientific
Primary contact
Mr BD Braithwaite
ORCID ID
Contact details
Department of Vascular Surgery
C Floor West Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924
BRUCE.BRAITHWAITE@QMC.NHS.UK
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192119061
Study information
Scientific title
Acronym
Study hypothesis
To determine whether VNUS is as effective as groin re-exploration for recurrent varicose veins in association with a recurrently incompetent long saphenous vein (LSV). Assessment will be by Duplex scan at 6 weeks, 1 year and 5 years.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular: Recurrent varicose veins
Intervention
VNUS closure compared with groin dissection and long saphenous vein (LSV) stripping for recurrent varicose veins
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Operative time, visual analogue scales for pain and bruising, costs of procedure, recurrence rates.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/07/2002
Overall trial end date
12/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Age 18-80
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
31/07/2002
Recruitment end date
12/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Vascular Surgery
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Queen's Medical Centre University Hospital NHS Trust (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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16137898
Publication citations
-
Results
Hinchliffe RJ, Ubhi J, Beech A, Ellison J, Braithwaite BD, A prospective randomised controlled trial of VNUS closure versus surgery for the treatment of recurrent long saphenous varicose veins., Eur J Vasc Endovasc Surg, 2006, 31, 2, 212-218, doi: 10.1016/j.ejvs.2005.07.005.