Endovascular Varicose vein Vnus® (endovenous radiofrequency ablation) vs Evlt (endovenous laser therapy) Randomised controlled Trial - EVVERT
| ISRCTN | ISRCTN63135694 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63135694 |
| Secondary identifying numbers | 08/H0803/162 |
- Submission date
- 15/10/2008
- Registration date
- 30/01/2009
- Last edited
- 18/01/2012
- 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 Ian Loftus
Scientific
Scientific
Department of Vascular Surgery
4th Floor
St James Wing
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0RE
United Kingdom
| Phone | +44 (0)20 8725 3205 |
|---|---|
| Ian.Loftus@stgeorges.nhs.uk |
Study information
| Study design | Double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Mr Ranjeet Brar (email: rbrar@sgul.ac.uk) to request a patient information sheet |
| Scientific title | A double-blind randomised controlled trial of radiofrequency versus laser treatment of great saphenous varicose veins |
| Study acronym | EVVERT |
| Study objectives | Null hypothesis: There is no difference in outcome between patients having their great saphenous varicose veins treated with endovascular radiofrequency (VNUS®) or endovenous laser therapy (EVLT) |
| Ethics approval(s) | The study was approved by St George's, University of London (REC reference: 08/H0803/162; R&D reference: 08.0112). |
| Health condition(s) or problem(s) studied | Symptomatic great saphenous varicose veins |
| Intervention | Endovenous laser therapy (EVLT) vs endovenous radiofrequency ablation (VNUS Closure®). Total duration of follow-up: 3 months |
| Intervention type | Other |
| Primary outcome measure | 1. Patency of great saphenous vein as measured by duplex scanning. This will be measured pre-operatively, at one week and three months post-operatively. 2. Health questionnaires, recorded pre-operatively and 3 months post-operatively. 2.1. Specific: Aberdeen Varicose Vein Symptom Severity score (AVVSS) 2.2. Generic: Euroqol EQ-5D |
| Secondary outcome measures | 1. Pain 1.1. Analogue pain score diary over first week 1.2. Record of analgesia taken. Duration of follow-up: 1 week 2. Bruising. Photographs of legs taken pre-operatively and 1 week post-operatively to assess degree of bruising. |
| Overall study start date | 01/10/2008 |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Both males and females 2. Primary varicose veins 3. Symptomatic 4. Great saphenous territory |
| Key exclusion criteria | 1. Unable to give informed consent 2. Age <18 or >80 3. Recurrent varicosities 4. Pregnant 5. Short saphenous incompetence 6. Tortuous great saphenous vein - not amenable to endovascular treatment 7. Deep vein thrombosis or pulmonary embolism within last year 8. Deep venous insufficiency 9. Warfarinised patient 10. Non-steroidal allergy |
| Date of first enrolment | 01/10/2008 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Vascular Surgery
London
SW17 0RE
United Kingdom
SW17 0RE
United Kingdom
Sponsor information
St George's, University of London (UK)
University/education
University/education
Cranmer Terrace
Tooting
London
SW17 0RE
England
United Kingdom
| Phone | +44 (0)20 8672 1255 |
|---|---|
| rbrar@sgul.ac.uk | |
| Website | http://www.sgul.ac.uk |
"ROR" |
https://ror.org/040f08y74 |
Funders
Funder type
Charity
St George's, University of London Charitable Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 | 01/12/2011 | Yes | No |
