Condition category
Circulatory System
Date applied
15/10/2008
Date assigned
30/01/2009
Last edited
18/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ian Loftus

ORCID ID

Contact details

Department of Vascular Surgery
4th Floor
St James Wing
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0RE
United Kingdom
+44 (0)20 8725 3205
Ian.Loftus@stgeorges.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

08/H0803/162

Study information

Scientific title

A double-blind randomised controlled trial of radiofrequency versus laser treatment of great saphenous varicose veins

Acronym

EVVERT

Study hypothesis

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

The study was approved by St George's, University of London (REC reference: 08/H0803/162; R&D reference: 08.0112).

Study design

Double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Mr Ranjeet Brar (email: rbrar@sgul.ac.uk) to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2008

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females
2. Primary varicose veins
3. Symptomatic
4. Great saphenous territory

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/10/2008

Recruitment end date

01/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Vascular Surgery
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

St George's, University of London (UK)

Sponsor details

Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom
+44 (0)20 8672 1255
rbrar@sgul.ac.uk

Sponsor type

University/education

Website

http://www.sgul.ac.uk

Funders

Funder type

Charity

Funder name

St George's, University of London Charitable Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21934487

Publication citations

  1. Results

    Nordon IM, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, Loftus IM, A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins., Ann. Surg., 2011, 254, 6, 876-881, doi: 10.1097/SLA.0b013e318230af5a.

Additional files

Editorial Notes