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 |
| Protocol serial number | 02 |
| Sponsor | Danish National Health Insurance (Denmark) |
| Funder | Danish National Health Insurance (Denmark) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Lars Rasmussen
Scientific
Scientific
Eskadronsvej 4A
Naestved
4700
Denmark
| lhr@varix.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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. |
| Health condition(s) or problem(s) studied | 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(s) |
Recurrent varicose veins after surgery (REVAS), measured at baseline, 1 month, 12 months, yearly thereafter for a total of 5 years. |
| Key secondary outcome measure(s) |
Measured at baseline, 1 month, 12 months, yearly thereafter for a total of 5 years: |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 500 |
| Total final enrolment | 500 |
| Key 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 |
| Key exclusion criteria | Aged below 18 and above 75 years |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/01/2012 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Eskadronsvej 4A
Naestved
4700
Denmark
4700
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/07/2019: Publication reference and total final enrolment added.
