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
Secondary identifying numbers N0211091334
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

The Whiteley Clinic
1 Stirling House
Stirling Road
Guildford, Surrey
GU2 7RF
United Kingdom

Phone +44 (0)1483 477180
Email info@thewhiteleyclinic.co.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedCardiovascular: Primary long saphenous varicose veins
InterventionRandomised controlled trial randomised into two groups:
Group 1 - subfascial endoscopic perforator vein surgery (SEPS)
Group 2 - standard open procedure
Intervention typeOther
Primary outcome measure1. Improvement in function measured by refill time,
2. Incidence of recurrent reflux
3. Clinical recurrence
4. Cosmetic results
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2000
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants72
Key inclusion criteria1. Venous reflux (greater than 0.5 s) of the greater saphenous vein (GSV)
2. Additional incompetent perforating veins (IPVs)
Key exclusion criteria1. Ulceration,
2. Recurrent veins
3. Deep venous reflux/thrombosis
4. Saphenopopliteal reflux
Date of first enrolment01/09/2000
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Whiteley Clinic
Guildford, Surrey
GU2 7RF
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Royal Surrey County Hospital NHS Trust (UK) - NHS R&D funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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