Endovenous laser therapy (EVLT) versus ultrasound-guided foam sclerotherapy (UGFS) for the treatment of varicose veins
| ISRCTN | ISRCTN03080206 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03080206 |
| Secondary identifying numbers | 08/H0710/78 |
- Submission date
- 21/01/2010
- Registration date
- 04/02/2010
- Last edited
- 04/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Varicose veins are swollen and enlarged veins that usually occur on the legs. The aim of this study is to compare two treatments for varicose veins: endovenous laser therapy and ultrasound-guided foam sclerotherapy. Endovenous laser therapy involves having a tiny laser inserted into the vein, which delivers bursts of energy that heat up the vein and seal it closed. Ultrasound-guided foam sclerotherapy involves injecting special foam into the vein, which seals it closed.
Who can participate?
Patients aged 18 or over with varicose veins
What does the study involve?
Participants are randomly allocated to be treated with either endovenous laser therapy or ultrasound-guided foam sclerotherapy. Participants are followed up for 5 years to assess their recovery, quality of life, pain and the costs of treatment.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Ealing Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2009 to May 2016
Who is funding the study?
1. Ealing Hospital NHS Trust (UK)
2. STD Pharmaceuticals Ltd (UK)
Who is the main contact?
George Geroulakos
g.geroulakos@imperial.ac.uk
Contact information
Scientific
Consultant Vascular Surgeon and Senior Lecturer
Ealing Hospital
Uxbridge Road
Southall
Middlesex
UB1 3HW
United Kingdom
| g.geroulakos@imperial.ac.uk |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised controlled trial of endovenous laser therapy (EVLT) versus ultrasound-guided foam sclerotherapy (UGFS) for the treatment of varicose veins |
| Study objectives | Patient recovery, quality of life, post-procedural pain and the direct medical costs of treatment are significantly different between endovenous laser therapy (EVLT) and ultrasound guided foam sclerotherapy (UGFS). |
| Ethics approval(s) | Ealing and West London Research Ethics Committee, 17/03/2009 |
| Health condition(s) or problem(s) studied | Chronic venous insufficiency |
| Intervention | Group 1: UGFS to the long saphenous vein Group 2: EVLT to the long saphenous vein and concurrent local anaesthetic phlebectomies Total duration of treatment ranges from the primary procedure (1 day) to two further optional sessions, 6 weeks apart (3 months). Total duration of follow-up is 3 months after the last treatment session. Updated 17/06/2014: Follow-up has been extended to 5 years after the last treatment session. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Return to normal activities 2. Quality of life using the Aberdeen Varicose Vein Questionnaire All outcomes will be assessed prior to the procedure (Day 0), at 3 weeks, then after optional adjuvant UGFS sessions and finally after a further 3 months. Air plethysmography will only be carried out before treatment and 3 months after the last treatment session. Updated 17/06/2014: Outcomes will be assessed and air plethysmography will be carried out at 5 years after the last treatment session. |
| Secondary outcome measures | 1. Direct medical costs 2. Number of treatment sessions 3. Incidence of side-effects and complications 4. Effectiveness of treatment using duplex and air plethysmography 5. Post-procedural pain scores using a visual analogue scale 6. Change in clinical severity using the venous clinical severity scoring system All outcomes will be assessed prior to the procedure (Day 0), at 3 weeks, then after optional adjuvant UGFS sessions and finally after a further 3 months. Air plethysmography will only be carried out before treatment and 3 months after the last treatment session. Updated 17/06/2014: Outcomes will be assessed and air plethysmography will be carried out at 5 years after the last treatment session. |
| Overall study start date | 01/04/2009 |
| Completion date | 31/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Adult patients (aged 18 years or over, either sex) with symptomatic primary varicose veins in the long saphenous distribution and reflux greater than 1 second on duplex scanning 2. Suitability for both techniques, foam and laser |
| Key exclusion criteria | 1. Saphenopopliteal junction incompetence 2. Previous surgery for varicose veins 3. Previous sclerotherapy for varicose veins 4. Deep vein thrombosis, previous or current 5. Significant arterial disease (Ankle Brachial Pressure Index [ABPI] less than 0.8) 6. Active malignancy 7. Coagulopathy 8. Pregnancy 9. Known allergies to local anaesthetics or sclerosants |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 31/05/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UB1 3HW
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Office
Pasteur Suite, 8th Floor
Uxbridge Road
Southall
Middlesex
UB1 3HW
England
United Kingdom
| gay.bineham@eht.nhs.uk | |
| Website | http://www.ealinghospital.nhs.uk/ |
"ROR" |
https://ror.org/0380w8h49 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2012 | Yes | No | |
| Results article | results | 01/08/2013 | Yes | No |
Editorial Notes
04/03/2016: Plain English summary added.
On 17/06/2014 the overall trial end date was changed from 31/03/2011 to 31/05/2016.
