EVLT for Sapheno-Popliteal incompetence and SS Reflux: A RCT
ISRCTN | ISRCTN56883670 |
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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
Scientific
Alderson House
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | Is 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) studied | Surgery: Short saphenous system varicose veins |
Intervention | Data 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 type | Procedure/Surgery |
Primary outcome measure | Residual SPJ incompetence on Duplex ultrasound |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 15/09/2005 |
Completion date | 01/09/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 106 |
Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 15/09/2005 |
Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Alderson House
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |