Randomised single blind patient controlled trial of VNUS closure compared with groin dissection and long saphenous vein (LSV) stripping for recurrent varicose veins
| ISRCTN | ISRCTN12878702 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12878702 |
| Protocol serial number | N0192119061 |
| Sponsor | Department of Health (UK) |
| Funder | Queen's Medical Centre University Hospital NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 26/08/2008
- 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 BD Braithwaite
Scientific
Scientific
Department of Vascular Surgery
C Floor West Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 924 9924 |
|---|---|
| BRUCE.BRAITHWAITE@QMC.NHS.UK |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine whether VNUS is as effective as groin re-exploration for recurrent varicose veins in association with a recurrently incompetent long saphenous vein (LSV). Assessment will be by Duplex scan at 6 weeks, 1 year and 5 years. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Recurrent varicose veins |
| Intervention | VNUS closure compared with groin dissection and long saphenous vein (LSV) stripping for recurrent varicose veins |
| Intervention type | Other |
| Primary outcome measure(s) |
Operative time, visual analogue scales for pain and bruising, costs of procedure, recurrence rates. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 12/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | Age 18-80 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 31/07/2002 |
| Date of final enrolment | 12/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Vascular Surgery
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
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 | 01/02/2006 | Yes | No |
