Contact information
Type
Scientific
Primary contact
Mr Mark Whiteley
ORCID ID
Contact details
The Whiteley Clinic
1 Stirling House
Stirling Road
Guildford
Surrey
GU2 7RF
United Kingdom
+44 (0)1483 477180
info@thewhiteleyclinic.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0211091334
Study information
Scientific title
Acronym
Study hypothesis
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
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
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
1. Improvement in function measured by refill time,
2. Incidence of recurrent reflux
3. Clinical recurrence
4. Cosmetic results
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2000
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Venous reflux (greater than 0.5 s) of the greater saphenous vein (GSV)
2. Additional incompetent perforating veins (IPVs)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
72
Participant exclusion criteria
1. Ulceration,
2. Recurrent veins
3. Deep venous reflux/thrombosis
4. Saphenopopliteal reflux
Recruitment start date
01/09/2000
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Whiteley Clinic
Guildford, Surrey
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 (UK) - NHS R&D funding
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17701962
Publication citations
-
Results
Kianifard B, Holdstock J, Allen C, Smith C, Price B, Whiteley MS, Randomized clinical trial of the effect of adding subfascial endoscopic perforator surgery to standard great saphenous vein stripping., Br J Surg, 2007, 94, 9, 1075-1080, doi: 10.1002/bjs.5945.