Is laser treatment or surgery the best way of treating varicose veins?

ISRCTN	ISRCTN99270116
DOI	https://doi.org/10.1186/ISRCTN99270116
Protocol serial number	VS03/2281
Sponsor	Leeds Teaching Hospitals NHS Trust (UK)
Funders	Leeds Teaching Hospitals NHS Trust (UK), Diomed Ltd (UK) - part of research fellow salary paid (£15,000 pa)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Michael Gough
Scientific

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

Primary study design	Interventional
Study design	Parallel group, non-blinded, randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Received from Leeds (West) Research Ethics Committee in May 2003 (ref: 03/052).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Abolition of GSV reflux at three months (duplex ultrasound) 2. Improvement in disease-specific quality of life (Aberdeen Varicose Vein Questionnaire)
Key secondary outcome measure(s)	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
Completion date	01/12/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	342
Key inclusion criteria	1. Symptomatic varicose veins 2. Primary sapheno-femoral incompetence with greater saphenous vein reflux
Key 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
Date of first enrolment	05/06/2003
Date of final enrolment	01/12/2006

Leeds Vascular Institute

Leeds
LS1 3EX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/03/2008		Yes	No