Randomised single blind patient controlled trial of VNUS closure compared with groin dissection and long saphenous vein (LSV) stripping for recurrent varicose veins

ISRCTN ISRCTN12878702
DOI https://doi.org/10.1186/ISRCTN12878702
Secondary identifying numbers N0192119061
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
26/08/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr BD Braithwaite
Scientific

Department of Vascular Surgery
C Floor West Block
University Hospital
Nottingham
NG7 2UH
United Kingdom

Phone +44 (0)115 924 9924
Email BRUCE.BRAITHWAITE@QMC.NHS.UK

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular: Recurrent varicose veins
InterventionVNUS closure compared with groin dissection and long saphenous vein (LSV) stripping for recurrent varicose veins
Intervention typeOther
Primary outcome measureOperative time, visual analogue scales for pain and bruising, costs of procedure, recurrence rates.
Secondary outcome measuresNot provided at time of registration
Overall study start date31/07/2002
Completion date12/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexNot Specified
Target number of participants60
Key inclusion criteriaAge 18-80
Key exclusion criteriaNot provided at time of registration
Date of first enrolment31/07/2002
Date of final enrolment12/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Vascular Surgery
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Queen's Medical Centre University Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2006 Yes No