A randomised controlled trial investigating the role of subfascial endoscopic perforator vein surgery (SEPS) in the prevention of recurrence in recurrent long saphenous varicose veins

ISRCTN ISRCTN77323728
DOI https://doi.org/10.1186/ISRCTN77323728
Secondary identifying numbers N0211091333
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
30/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mark Whiteley
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA randomised controlled trial investigating the role of subfascial endoscopic perforator vein surgery (SEPS) in the prevention of recurrence in recurrent long saphenous varicose veins
Study objectivesTo evaluate the advantages of SEPS to the standard open procedure - recurrent long saphenous varicose veins.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular: Recurrent 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 typeProcedure/Surgery
Primary outcome measureImprovement in function measured by refill time, incidence of recurrent reflux, clinical recurrence, and cosmetic results.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2000
Completion date31/03/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients with recurrent varicose veins, undergoing surgery, with Duplex proven incompetent perforating veins
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/09/2000
Date of final enrolment31/03/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Whiteley Clinic
Guildford
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

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

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator.