Randomised trial of Polytetrafluoroethylene (PTFE) patch saphenoplasty in patients having surgery for recurrent long saphenous varicose veins
| ISRCTN | ISRCTN86810172 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86810172 |
| Secondary identifying numbers | N0106092280 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 17/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Jonathan Earnshaw
Scientific
Scientific
Consultant Surgeon
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To compare the use of a PTFE patch with normal repair for surgery for recurrent varicose veins. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Long saphenous varicose veins |
| Intervention | 1. Polytetrafluoroethylene patch 2. Flush ligation |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | To reduce the re-recurrence rate after reoperative surgery for recurrent long saphenous varicose veins. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2003 |
| Completion date | 28/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 50 |
| Key inclusion criteria | At least 50 patients having surgery for recurrent long saphenous varicose veins. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 28/02/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Surgeon
Gloucester
GL1 3NN
United Kingdom
GL1 3NN
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Gloucestershire R&D Consortium (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 | 01/09/2007 | Yes | No |
