EVLT for Sapheno-Popliteal incompetence and SS Reflux: A RCT

ISRCTN	ISRCTN56883670
DOI	https://doi.org/10.1186/ISRCTN56883670
Protocol serial number	N0084174061
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	The North and South Bank Research and Development Consortium (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Anthony Mekako
Scientific

Alderson House
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is Endo Venous Laser Therapy (EVLT) superior to conventional surgery for Short Saphenous system varicose veins?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Short saphenous system varicose veins
Intervention	Data will be collected using an IBM computer and a specifically designed Microsoft Access database. The primary outcome measure will be compared between the groups by a chi-square test with continuity correction. Quality of life measures at each time point will be compared between the groups by an analysis of covariance, adjusting for the corresponding baseline values. Statistical advice will be sought from Dr Eric Gardiner, statistical consultant, who holds an honorary contract with the Hull and East Yorkshire Hospitals Trust. Health Economic advice regarding cost effectiveness / benefit analysis will be sought from the Centre of Health Economics, the University of York. Randomisation will be carried out using envelopes method.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Residual SPJ incompetence on Duplex ultrasound
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/09/2007

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	106
Key inclusion criteria	1. C2-C5 graded varicose veins 2. Patients that have demonstrated to have isolated SPJ incompetence and/or SSV reflux on Duplex scan 3. Patients in whom the most appropriate treatment is surgery (opinion of the patient/surgeon) 5. Patients able to give informed written consent
Key exclusion criteria	1. Patients whose varicose veins will be conservatively managed 2. Inability to give informed written consent 3. Symptomatic varicose veins which on venous duplex are not attributable to SPJ incompetence and SSV reflux 4. Evidence of deep venous reflux on duplex scan 5. Patients on anticoagulants
Date of first enrolment	15/09/2005
Date of final enrolment	01/09/2007

Alderson House

Hull
HU3 2JZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2006		Yes	No