Vein ablation versus conventional surgery for varicose veins
| ISRCTN | ISRCTN29015169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29015169 |
| Secondary identifying numbers | 2003/190 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mr Tim Lees
Scientific
Scientific
Consultant Vascular Surgeon
Northern Vascular Centre
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom
Study information
| Study design | Randomised controlled trial using web-based method |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 hypothesis | 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). |
| Condition | 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 | 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. |
| Secondary outcome measures | 1. Time to return to normal activities and work 2. Quality of life, estimated using Aberdeen Varicose Vein Questionnaire, Venous Insufficiency Epidemiologic and Economic Study of Quality-of-Life and Symptoms (VEINES-QOL/Sym) questionnaire, 36-item short form health survey (SF-36) and EuroQOL-5D generic questionnaires Measurement of outcomes will be carried out at the end of one week, six weeks, one year and five years. |
| Overall study start date | 01/04/2004 |
| Overall study end date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant 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 |
| Participant exclusion criteria | 1. Associated short saphenous and deep vein incompetence 2. Pregnancy 3. Patients with pacemaker or defibrillator |
| Recruitment start date | 01/04/2004 |
| Recruitment end date | 31/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Vascular Surgeon
Newcastle upon Tyne
NE7 7DN
United Kingdom
NE7 7DN
United Kingdom
Sponsor information
VNUS Medical Technologies UK Ltd (UK)
Industry
Industry
Kenneth Dibben House
Enterprise Road
Southampton Science Park
Chilworth, Hampshire
SO16 7NS
United Kingdom
| Website | http://www.vnus.com/uk |
|---|---|
"ROR" |
https://ror.org/020hbh524 |
Funders
Funder type
Industry
VNUS Medical Technologies UK Ltd (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 | 01/01/2010 | Yes | No |
