Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins
| ISRCTN | ISRCTN51995477 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51995477 |
| Secondary identifying numbers | HTA 06/45/02 |
- Submission date
- 25/02/2008
- Registration date
- 29/02/2008
- Last edited
- 05/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Up to 15% of men and 25% of women at some point in their life develop swollen and enlarged veins called varicose veins. This results in about 95,000 operations being performed each year in the NHS in England alone. There is considerable variation across the UK in accessing treatment for varicose veins, and also to the type of treatment offered. The most common treatment offered is surgery, which involves stripping out the veins under general anaesthetic. Recently, new treatments have been developed for treating varicose veins. These are called minimally invasive techniques as they can be given under local anaesthetic and so avoid the scars and bruising associated with surgery. They may also allow a quicker return to normal daily activities and work, more rapid treatment for a greater number of people, and result in fewer complications. They also allow expensive operating theatre time to be freed up. The two most common types of minimally invasive treatment are foam sclerotherapy and endovenous laser ablation. Foam sclerotherapy involves injecting special foam into your veins that scars the veins and seals them closed. Endovenous laser treatment involves having a tiny laser inserted into your vein which delivers energy that heats up the vein and seals it closed. Both techniques have been classified as safe to use in the NHS, although we have been advised to carefully monitor any side effects that might occur following foam sclerotherpy. Despite good short-term results, success in the long term is unclear. This study will assess this and determine the need for a second course of treatment.
Who can participate?
Patients aged over 18 with varicose veins
What does the study involve?
Participants are randomly allocated to be treated with either surgery, foam sclerotherapy or both endovenous laser ablation and foam sclerotherapy. Participants are followed-up for six months initially (and then for up to 5 years) and are asked about their varicose veins, their general health and any visits to their GP or hospital about their varicose veins.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Aberdeen Royal Infirmary (UK)
When is the study starting and how long is it expected to run for?
June 2008 to May 2011
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Julie Brittenden
j.brittenden@abdn.ac.uk
Contact information
Scientific
c/o Vascular Department
Ward 36
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
| j.brittenden@abdn.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: https://w3.abdn.ac.uk/hsru/class/site/Public_New/DownloadPage.aspx |
| Scientific title | Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins |
| Study hypothesis | Foam sclerotherapy is more cost-effective in terms of incremental cost per quality-adjusted life year compared to surgery or laser therapy. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/064502 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0004/51448/PRO-06-45-02.pdf |
| Ethics approval(s) | Not provided at time of registration - submission pending as of 25/02/2008 |
| Condition | Varicose veins |
| Intervention | Arm 1: Foam sclerotherapy Arm 2: Foam sclerotherapy + endovenous laser therapy Arm 3: Conventional surgery |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The following will be assessed at 6 months: Primary patient outcome: 1. Disease specific: Aberdeen Varicose Vein Questionnaire 2. Generic: EuroQol (EQ-5D), the 36-item Short Form health survey (SF-36) Primary economic outcome: 3. Incremental cost per quality adjusted life year (QALY) |
| Secondary outcome measures | 1. Costs to the health service and patients and any subsequent care 2. Technical success of venous intervention at 6 weeks and 6 months 3. Clinical success of venous intervention at 6 weeks and 6 months 4. Disease-specific and generic quality of life at 6 weeks 5. Behavioural recovery |
| Overall study start date | 01/06/2008 |
| Overall study end date | 31/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,015 |
| Total final enrolment | 798 |
| Participant inclusion criteria | 1. Adult patients (aged over 18 years old) 2. Those who are referred to the surgical out-patient department for treatment of primary varicose veins with symptomatic (CEAP [Clinical, Etiological, Anatomical, Pathological elements] classification grade 2 or above) primary long or short saphenous main stem incompetence (reflux >1 second on duplex scanning) 3. Suitable for day case treatment |
| Participant exclusion criteria | 1. Current deep vein thrombosis 2. Deep venous incompetence 3. Acute superficial vein thrombosis 4. Allergy to sclerosant 5. Pregnancy or breastfeeding 6. History of hypercoagulability 7. Arterial disease (ankle brachial pressure index <0.8) 8. Inability to mobilise post-procedure 9. Needle phobia 10. Long or short saphenous vein less than 3 mm in diameter or greater than 15 mm and tortuous veins that are considered to be unsuitable for endovenous laser ablation (EVLA) due to difficulties in passing the guide wire 11. Inability to complete study questionnaires |
| Recruitment start date | 01/06/2008 |
| Recruitment end date | 31/05/2011 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
AB25 2ZN
United Kingdom
Sponsor information
University/education
c/o Dr E Rattray
Research & Innovation
University Office
Kings College
Aberdeen
AB24 3FX
Scotland
United Kingdom
| Website | http://www.abdn.ac.uk |
|---|---|
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
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 | 25/09/2014 | Yes | No | |
| Results article | results | 01/11/2014 | Yes | No | |
| Results article | results | 01/04/2015 | Yes | No | |
| Results article | 5-year results | 05/09/2019 | Yes | No |
Editorial Notes
05/09/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
07/06/2016: Plain English summary added.
