RCT comparing modified EVLT (endovenous laser treatment) techniques with standard EVLT technique

ISRCTN	ISRCTN02281581
DOI	https://doi.org/10.1186/ISRCTN02281581
Protocol serial number	N0436169958
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 14/05/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Michael Gough
Scientific

Vascular Surgical Unit
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 0113 392 3951
Email	michael.gough@leedsth.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Modifications of laser technique might result better clinical outcome in the treatment of varicose veins due to sapheno-femoral and long saphenous incompetence. This study is designed to answer 2 questions: 1. Do these modifications result in improved symptom relief and cosmetic appearance after treatment of varicose veins? 2. Does one of these techniques reduce the total number of follow up sclerotherapy sessions needed to complete the treatment of varicose veins?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular: Varicose veins
Intervention	2 different types of modified EVLT (endovenous laser treatment) techniques vs standard EVLT technique.
Intervention type	Other
Primary outcome measure(s)	1. The total number of follow up sclerotherapy sessions required to complete the treatment. 2. Technical success: determined by duplex ultrasound of LSV: 2.1 Successful: occlusion and non compressibility of the LSV without blood flow throughout the treated length 2.2 Partial response: segmental occlusion of LSV and abolition of distal reflux 2.3 Failure: reflux in treated LSV any time after treatment 3. Improvement in symptoms, using the Aberdeen Vein Questionnaire, a previously validated disease-specific quality of life instrument 4. Review and quantification of varicosities on post-EVLT photographs both prior to and after completion of sclerotherapy
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	207
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2005
Date of final enrolment	01/10/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Vascular Surgical Unit

Leeds
LS1 3EX
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes