Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0211091333
Study information
Scientific title
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
Acronym
Study hypothesis
To evaluate the advantages of SEPS to the standard open procedure - recurrent long saphenous varicose veins.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Cardiovascular: Recurrent 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
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Improvement in function measured by refill time, incidence of recurrent reflux, clinical recurrence, and cosmetic results.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2000
Overall trial end date
31/03/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with recurrent varicose veins, undergoing surgery, with Duplex proven incompetent perforating veins
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/09/2000
Recruitment end date
31/03/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Whiteley Clinic
Guildford
GU2 7RF
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Surrey County Hospital NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary