Condition category
Circulatory System
Date applied
11/06/2007
Date assigned
10/07/2007
Last edited
19/03/2008
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 Michael Gough

ORCID ID

Contact details

Leeds Vascular Institute
The General Infirmary at Leeds
Great George Street
Leeds
LS1 3EX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VS03/2281

Study information

Scientific title

Acronym

Study hypothesis

Endovenous laser ablation (EVLA) produces comparable short-term results to surgery (abolition of great saphenous vein [GSV] reflux and improvement in symptoms) for the treatment of primary varicose veins due to sapheno-femoral incompetence with greater saphenous vein reflux.

Ethics approval

Received from Leeds (West) Research Ethics Committee in May 2003 (ref: 03/052).

Study design

Parallel group, non-blinded, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Varicose veins

Intervention

Endovenous laser treatment (810 nm diode laser, Diomed) versus sapheno-femoral ligation, greater saphenous vein stripping and avulsions (surgery).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Abolition of GSV reflux at three months (duplex ultrasound)
2. Improvement in disease-specific quality of life (Aberdeen Varicose Vein Questionnaire)

Secondary outcome measures

1. Time to return to work and to normal activity
2. Pain and analgesia use during first week following treatment
3. Overall satisfaction and satisfaction with cosmetic outcome
4. Generic quality of life (36-item Short Form health survey [SF-36]) at 1 and 12 weeks following treatment
5. Complications

Overall trial start date

05/06/2003

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Symptomatic varicose veins
2. Primary sapheno-femoral incompetence with greater saphenous vein reflux

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

342

Participant exclusion criteria

1. Unable to consent
2. Children (under 18 years)
3. Unfit for general anaesthesia
4. Recurrent varicose veins
5. Patients on long-term anticoagulation
6. Patients with anterior thigh branch of greater saphenous vein arising within 10 cm of groin and competent GSV distal to this

Recruitment start date

05/06/2003

Recruitment end date

01/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds Vascular Institute
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Leeds Teaching Hospitals NHS Trust (UK)

Sponsor details

Leeds Vascular Institute
The General Infirmary at Leeds
Great George Street
Leeds
LS1 3EX
United Kingdom

Sponsor type

Government

Website

http://www.leedsteachinghospitals.com/

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Diomed Ltd (UK) - part of research fellow salary paid (£15,000 pa)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18278775

Publication citations

  1. Results

    Darwood RJ, Theivacumar N, Dellagrammaticas D, Mavor AI, Gough MJ, Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins., Br J Surg, 2008, 95, 3, 294-301, doi: 10.1002/bjs.6101.

Additional files

Editorial Notes