Ultrasound guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins
| ISRCTN | ISRCTN62966817 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62966817 |
| Secondary identifying numbers | G Geroulakos |
- Submission date
- 15/12/2010
- Registration date
- 20/04/2011
- Last edited
- 22/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr George Geroulakos
Scientific
Scientific
Ealing Hospital
Uxbridge Road
Southall
Middlesex
UB1 3HW
United Kingdom
Study information
| Study design | Single centre randomised controlled parallel group 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 contolled trial of ultrasound guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins |
| Study objectives | The hypothesis of this study is that duplex guided foam sclerotherapy in combination with saphenofemoral ligation under local anaesthesia may save costs and treatment time and be more acceptable for patients than ligation and stripping of the greater saphenous vein and phlebectomies. This is because there is no need for general anaesthesia and it is a less invasive procedure. |
| Ethics approval(s) | The Ealing and Mental Health Ethics Committee approved in 2003 (ref: LREC 03/04) |
| Health condition(s) or problem(s) studied | Chronic venous insufficiency |
| Intervention | Group surgery: 1. High saphenofemoral ligation 2. Strip to the knee 3. Multiple phlebectomies Group surgery and foam: High saphenofemoral ligation under local anaesthesia and foam sclerotherapy under ultrasound guidance. Both arms had 5 years treatment/ follow up (some patients up to a max of 7 years) |
| Intervention type | Other |
| Primary outcome measure | 1. Patient recovery period 2. Quality of life Outcome measured up to 7 years maximum |
| Secondary outcome measures | 1. Frequency of complications 2. Cost of the treatment Outcome measured up to 7 years maximum |
| Overall study start date | 01/07/2003 |
| Completion date | 01/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Primary symptomatic varicose veins involving the great saphenous system in patients whom had had no previous treatment for varicose veins and who were suitable for day case surgery |
| Key exclusion criteria | 1. Primary varicosities involving the short saphenous vein 2. Patients with previous surgery or sclerotherapy for varicose veins 3. Previous deep vein thrombosis (DVT) 4. Risk factors for DVT 5. Coagulopathy 6. Peripheral vascular disease 7. Known allergy to anaesthetic or sclerosing agents 8. Previous iatrogenic allergic reaction 9. Malignancy 10. Pregnancy |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 01/02/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ealing Hospital
Middlesex
UB1 3HW
United Kingdom
UB1 3HW
United Kingdom
Sponsor information
Ealing Hospital NHS Trust (UK)
Hospital/treatment centre
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
Industry
STD Pharmaceuticals (UK)
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 | 01/02/2012 | Yes | No |
