EVLT for Sapheno-Popliteal incompetence and SS Reflux: A RCT

ISRCTN ISRCTN56883670
DOI https://doi.org/10.1186/ISRCTN56883670
Secondary identifying numbers N0084174061
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
15/11/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Anthony Mekako
Scientific

Alderson House
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

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 objectivesIs Endo Venous Laser Therapy (EVLT) superior to conventional surgery for Short Saphenous system varicose veins?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Short saphenous system varicose veins
InterventionData will be collected using an IBM computer and a specifically designed Microsoft Access database. The primary outcome measure will be compared between the groups by a chi-square test with continuity correction. Quality of life measures at each time point will be compared between the groups by an analysis of covariance, adjusting for the corresponding baseline values. Statistical advice will be sought from Dr Eric Gardiner, statistical consultant, who holds an honorary contract with the Hull and East Yorkshire Hospitals Trust. Health Economic advice regarding cost effectiveness / benefit analysis will be sought from the Centre of Health Economics, the University of York.
Randomisation will be carried out using envelopes method.
Intervention typeProcedure/Surgery
Primary outcome measureResidual SPJ incompetence on Duplex ultrasound
Secondary outcome measuresNot provided at time of registration
Overall study start date15/09/2005
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants106
Key inclusion criteria1. C2-C5 graded varicose veins
2. Patients that have demonstrated to have isolated SPJ incompetence and/or SSV reflux on Duplex scan
3. Patients in whom the most appropriate treatment is surgery (opinion of the patient/surgeon)
5. Patients able to give informed written consent
Key exclusion criteria1. Patients whose varicose veins will be conservatively managed
2. Inability to give informed written consent
3. Symptomatic varicose veins which on venous duplex are not attributable to SPJ incompetence and SSV reflux
4. Evidence of deep venous reflux on duplex scan
5. Patients on anticoagulants
Date of first enrolment15/09/2005
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Alderson House
Hull
HU3 2JZ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The North and South Bank Research and Development Consortium (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 01/07/2006 Yes No