Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0106092280
Study information
Scientific title
Acronym
Study hypothesis
To compare the use of a PTFE patch with normal repair for surgery for recurrent 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
Condition
Surgery: Long saphenous varicose veins
Intervention
1. Polytetrafluoroethylene patch
2. Flush ligation
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
To reduce the re-recurrence rate after reoperative surgery for recurrent long saphenous varicose veins.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2003
Overall trial end date
28/02/2007
Reason abandoned
Eligibility
Participant inclusion criteria
At least 50 patients having surgery for recurrent long saphenous varicose veins.
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2003
Recruitment end date
28/02/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Surgeon
Gloucester
GL1 3NN
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
Gloucestershire R&D Consortium (UK)
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 on http://www.ncbi.nlm.nih.gov/pubmed/17512226
Publication citations
-
Results
Winterborn RJ, Earnshaw JJ, Randomised trial of polytetrafluoroethylene patch insertion for recurrent great saphenous varicose veins., Eur J Vasc Endovasc Surg, 2007, 34, 3, 367-373, doi: 10.1016/j.ejvs.2007.03.019.