Condition category
Circulatory System
Date applied
27/11/2008
Date assigned
03/12/2008
Last edited
16/03/2011
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

Prof Alun Davies

ORCID ID

Contact details

4 East Department of Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRO1037

Study information

Scientific title

VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins (VALVV): a randomised clinical trial

Acronym

VALVV

Study hypothesis

Radiofrequency ablation using VNUS® ClosureFAST™ will result in significantly less post-operative pain and a greater improvement in quality of life in comparison to laser ablation.

As of 11/08/2009 this record has been updated to indicate that this trial has now closed to recruitment. The end of recruitment date was 30/06/2009. Follow-up will continue until 31/01/2010.

Ethics approval

Charing Cross Research Ethics Committee gave approval on 6th May 2008 (ref: 08/H0711/19)

Study design

Prospective randomised single-blind clinical trial, single centre

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Varicose veins

Intervention

1. Endovenous radiofrequency ablation 6-month follow-up duration
2. Endovenous laser ablation 6-month follow-up duration

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Average pain score at day 3 and day 10 following the procedure measured using an ungraduated visual analogue score (VAS) 0 = no pain, 10 = worst pain imaginable for 10 days following the procedure.

Secondary outcome measures

1. Use of analgesia, measured at 10 days
2. Improvement in quality of life using the Aberdeen Varicose Vein Questionnaire (AVVQ), the 12-item Short Form (SF-12) and the Specific Quality of Life and Outcome Response - Venous (SQOR-V) questionnaires pre-operatively and at 6 weeks post-intervention
3. Abolition of reflux at 6 months measured using colour duplex
4. Improvements in venous refill times using digitial photoplethysmography, measured at 6 weeks and 6 months
5. Clinical improvement measured using the CEAP, Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS), measured at 6 weeks and 6 months
6. Return to normal activities and or work
7. Complications, assessed throughout the duration of the patient participation (6 months)

Overall trial start date

07/07/2008

Overall trial end date

31/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged over 18 years, either sex
2. Venous reflux of the great saphenous vein

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

170

Participant exclusion criteria

1. Patients unfit for general anaesthesia
2. Current deep vein thrombosis
3. Previous venous surgery
4. Significant peripheral vascular disease/Ankle Brachial Blood Pressure Index (ABPI) less than 0.8

Recruitment start date

07/07/2008

Recruitment end date

31/01/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

4 East Department of Vascular Surgery
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

c/o Gary Roper
Research Governance Manager of Imperial College
Clinical Reserach Governance Office
G02
Sir Alexander Fleming Building
Exhibition Road
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Charity

Funder name

Mason Medical Research Foundation (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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20473992
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21129895

Publication citations

  1. Results

    Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, Davies AH, Randomized clinical trial of VNUS ClosureFAST radiofrequency ablation versus laser for varicose veins., Br J Surg, 2010, 97, 6, 810-818, doi: 10.1002/bjs.7091.

  2. Results

    Shepherd AC, Gohel MS, Lim CS, Davies AH, A study to compare disease-specific quality of life with clinical anatomical and hemodynamic assessments in patients with varicose veins., J. Vasc. Surg., 2011, 53, 2, 374-382, doi: 10.1016/j.jvs.2010.09.022.

Additional files

Editorial Notes