Endovenous laser ablation (EVLA), radio frequency (RF), foam sclerotherapy and stripping for treatment of varicose veins
| ISRCTN | ISRCTN08060326 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08060326 |
| Secondary identifying numbers | 02 |
- Submission date
- 31/07/2009
- Registration date
- 27/08/2009
- Last edited
- 11/07/2019
- 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
Not provided at time of registration
Contact information
Dr Lars Rasmussen
Scientific
Scientific
Eskadronsvej 4A
Naestved
4700
Denmark
| lhr@varix.dk |
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 | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of endovenous laser ablation (EVLA), radio frequency (RF), foam sclerotherapy and stripping for treatment of varicose veins |
| Study acronym | SOL |
| Study hypothesis | Endovenous laser ablation (EVLA), radio frequency (RF), foam sclerotherapy and stripping for the treatment of varicose veins all have equal outcomes. |
| Ethics approval(s) | Regional ethics committee approved of this trial prior to first patient enrolment. |
| Condition | Varicose veins |
| Intervention | 1. Surgery: high ligation and stripping plus stab phlebectomies 2. Endovenous laser ablation plus phlebectomies 3. Radiofrequency ablation plus phlebectomies 4. Ultrasound guided foam sclerotherapy plus phlebectomies Duration of treatments: 1 hour Duration of follow up: 5 years |
| Intervention type | Other |
| Primary outcome measure | Recurrent varicose veins after surgery (REVAS), measured at baseline, 1 month, 12 months, yearly thereafter for a total of 5 years. |
| Secondary outcome measures | Measured at baseline, 1 month, 12 months, yearly thereafter for a total of 5 years: 1. Quality of life 2. Varicose vein severity score (VVSS) |
| Overall study start date | 01/01/2007 |
| Overall study end date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 500 |
| Participant inclusion criteria | 1. Varicose veins due to greater saphenous vein (GSV) insufficiency 2. Aged greater than or equal to 18 years, to an upper limit of 75 years, either sex |
| Participant exclusion criteria | Aged below 18 and above 75 years |
| Recruitment start date | 01/01/2007 |
| Recruitment end date | 01/01/2012 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Eskadronsvej 4A
Naestved
4700
Denmark
4700
Denmark
Sponsor information
Danish National Health Insurance (Denmark)
Government
Government
Danske regioner
Dampfærgevej
Copenhagen
5112
Denmark
| dr@regioner.dk |
Funders
Funder type
Government
Danish National Health Insurance (Denmark)
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 | 01/08/2011 | 11/07/2019 | Yes | No |
| Results article | results | 01/10/2013 | 11/07/2019 | Yes | No |
Editorial Notes
11/07/2019: Publication reference and total final enrolment added.
