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
Protocol serial number	08/H0803/162
Sponsor	St George's, University of London (UK)
Funder	St George's, University of London Charitable Trust (UK)

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

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
Email	Ian.Loftus@stgeorges.nhs.uk

Study information

Primary study design	Interventional
Study design	Double-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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.
Completion date	01/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Department of Vascular Surgery

London
SW17 0RE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes