Vein ablation versus conventional surgery for varicose veins
| ISRCTN | ISRCTN29015169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29015169 |
| Protocol serial number | 2003/190 |
| Sponsor | VNUS Medical Technologies UK Ltd (UK) |
| Funder | VNUS Medical Technologies UK Ltd (UK) |
- Submission date
- 08/11/2007
- Registration date
- 05/02/2008
- Last edited
- 26/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Consultant Vascular Surgeon
Northern Vascular Centre
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial using web-based method |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised controlled trial of Radiofrequency Ablation of the long saphenous vein versus Conventional Saphenofemoral disconnection and stripping in the treatment of varicose veins |
| Study acronym | RACS |
| Study objectives | Radiofrequency ablation has the potential to improve the outcome of patients undergoing surgical treatment for varicose veins due to superficial venous incompetence. |
| Ethics approval(s) | Ethics approval received from the Newcastle and North Tyneside Local Research Ethics Committees on the 1st December 2003. Please note that the sponsor and funder of the trial at the time of ethics approval was Mantis Surgical Ltd (UK). |
| Health condition(s) or problem(s) studied | Varicose veins of lower limbs |
| Intervention | 1. Radiofrequency ablation 2. Conventional saphenofemoral disconnetion and stripping Both procedures are to be performed under general anaesthetic during a single operation. Based on their allocation patients would either receive radiofrequency ablation of their long saphenous vein or stripping of their long saphenous vein. Both groups will undergo multiple stab avulsions or phlebectomies as deemed necessary to complete the operation in the same setting. Both groups are expected to be followed up for five years. |
| Intervention type | Other |
| Primary outcome measure(s) |
Elimination of long saphenous vein reflux and elimination of truncal varicosities. Measurement of outcomes will be carried out at the end of one week, six weeks, one year and five years. |
| Key secondary outcome measure(s) |
1. Time to return to normal activities and work |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Patients aged 18 - 70 years, both sexes 2. Varicose veins due to isolated long saphenous vein incompetence proven on duplex scan 3. Requiring surgery 4. Long saphenous vein suitable for radiofrequency ablation |
| Key exclusion criteria | 1. Associated short saphenous and deep vein incompetence 2. Pregnancy 3. Patients with pacemaker or defibrillator |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
NE7 7DN
United Kingdom
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 | 01/01/2010 | Yes | No |
