| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN99270116 |
| Date ISRCTN assigned | 10/07/2007 |
| Local reference number(s) | VS03/2281 |
| Public title | Is laser treatment or surgery the best way of treating varicose veins? |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Varicose veins |
| 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. |
| Design/methodology | Parallel group, non-blinded, randomised controlled trial |
| Research ethics review | Received from Leeds (West) Research Ethics Committee in May 2003 (ref: 03/052). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Symptomatic varicose veins
2. Primary sapheno-femoral incompetence with greater saphenous vein reflux |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 05/06/2003 |
| Anticipated end date | 01/12/2006 |
| Status of trial | Completed |
| Target number of participants | 342 |
| Interventions | Endovenous laser treatment (810 nm diode laser, Diomed) versus sapheno-femoral ligation, greater saphenous vein stripping and avulsions (surgery). |
| 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) |
| 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 |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/18278775 |
| Sources of funding | 1. Leeds Teaching Hospitals NHS Trust (UK)
2. Diomed Ltd (UK) - part of research fellow salary paid (£15,000 pa) |
| Sponsor name | Leeds Teaching Hospitals NHS Trust (UK) |
| Sponsor details | Leeds Vascular Institute
The General Infirmary at Leeds
Great George Street
Leeds
United Kingdom
LS1 3EX |
| Sponsor website | http://www.leedsteachinghospitals.com/ |
| Contact name | Mr Michael Gough |
| Contact details | Leeds Vascular Institute
The General Infirmary at Leeds
Great George Street
Leeds
United Kingdom
LS1 3EX |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN99270116 |
| Date last extracted from ISRCTN register | 17/04/2008 |
