A randomised controlled trial investigating the role of subfascial endoscopic perforator vein surgery (SEPS) in the prevention of recurrence in primary long saphenous varicose veins
| ISRCTN | ISRCTN18288048 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18288048 |
| Protocol serial number | N0211091334 |
| Sponsor | Department of Health (UK) |
| Funder | Royal Surrey County Hospital NHS Trust (UK) - NHS R&D funding |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 21/10/2010
- 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 of protocol
Not provided at time of registration
Contact information
Mr Mark Whiteley
Scientific
Scientific
The Whiteley Clinic
1 Stirling House
Stirling Road
Guildford, Surrey
GU2 7RF
United Kingdom
| Phone | +44 (0)1483 477180 |
|---|---|
| info@thewhiteleyclinic.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To investigate the fate of incompetent perforating veins (IPVs) following saphenofemoral ligation and stripping of the great saphenous vein (GSV), with or without subfascial endoscopic perforator surgery (SEPS) |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Primary long saphenous varicose veins |
| Intervention | Randomised controlled trial randomised into two groups: Group 1 - subfascial endoscopic perforator vein surgery (SEPS) Group 2 - standard open procedure |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Improvement in function measured by refill time, |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 72 |
| Key inclusion criteria | 1. Venous reflux (greater than 0.5 s) of the greater saphenous vein (GSV) 2. Additional incompetent perforating veins (IPVs) |
| Key exclusion criteria | 1. Ulceration, 2. Recurrent veins 3. Deep venous reflux/thrombosis 4. Saphenopopliteal reflux |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Whiteley Clinic
Guildford, Surrey
GU2 7RF
United Kingdom
GU2 7RF
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 | 01/09/2007 | Yes | No |
