Randomised controlled trial of standard EndoVenous Laser Ablation (EVLA) versus standard EVLA with below-knee foam sclerotherapy versus above and below-knee EVLA for varicose veins

ISRCTN	ISRCTN31316759
DOI	https://doi.org/10.1186/ISRCTN31316759
Protocol serial number	N/A
Sponsor	Leeds General Infirmary (UK)
Funder	Leeds Vascular Institute (UK) - Research Fund

Submission date: 05/07/2007
Registration date: 26/07/2007
Last edited: 05/05/2011

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 Nadarajah Theivacumar
Scientific

Leeds Vascular Institute
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)7940 774550
Email	nadacumar@yahoo.co.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial (not blinded)
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Leeds EVLA technique trial
Study objectives	Modified techniques reduces requirement of delayed foam sclerotherapy and provides better clinical outcome.
Ethics approval(s)	Leeds (West) research ethics committee, at Leeds General Infirmary on 21/09/2005 (ref: 05/Q1205/187)
Health condition(s) or problem(s) studied	Varicose veins
Intervention	Two modified techniques are compared with standard EVLA technique: Group A: the standard practice of EVLA (laser ablation of above-knee Great Saphenous Vein [GSV]) considered as control Group B: modification 1 - where GSV was ablated (EVLA) both above and below knee Group C: modification 2 - where above knee GSV was ablated by EVLA and below knee GSV was chemically ablated using foam sclerotherapy at the same time Group 1 - standard EVLA alone: This uses an 810 nm bare-tipped, pulsed laser (Diomed Inc.) at a power of 12 watts. The standard technique for EVLA will be used employing a laser density of 5 pulse/cm. Delayed foam sclerotherapy up to 5 ml of 0.2-1% STD was used as required at the follow up clinic visit/s. Group 2 - standard EVLA and on table foam sclerotherapy: The same EVLA technique as for group 1 was used except that the GSV was cannulated below-knee (mid-calf) and a 70 cm sheath inserted. The GSV was ablated (EVLA) to the level of the knee joint following which 5 ml 1% STD (2 ml 1% STD, 3 ml air) will be injected into the below knee GSV via the sheath as it was withdrawn. Delayed foam sclerotherapy up to 5 ml of 0.2-1% STD was also be used as required at the follow up clinic visit/s. Group 3 - above and below-knee EVLA: The GSV was canulated below-knee (mid-calf) and the whole length of the GSV ablated using the standard EVLA technique. Delayed foam sclerotherapy up to 5 ml of 0.2-1% STD was also used as required at the follow up clinic visit/s. Following this primary treatment patients were followed up at 1, 6, and 12 weeks and following data were obtained at each visit: 1. At 1 week: 1.1. Daily Visual Analogue Score for pain 1.2. Analgesia diary 1.3. Time to normal activity - time to return to work 1.4. Assessment of post-treatment complications 1.5. Duplex assessment of GSV and deep veins for evidence of Deep Vein Thrombosis (DVT) 2. At 6 weeks: 2.1. Outstanding data from week 1 2.2. Aberdeen Vein Questionnaire (disease-specific quality of life measure)* 2.3. Late complications 2.4. Time of return to work if greater than 1 week 2.5. Injection sclerotherapy as required in all patients 2.6. Duplex assessment of GSV 3. At 12 weeks: 3.1. Any outstanding data (as above) 3.2. Duplex Ultrasound Assessment 3.3. Aberdeen Vein Questionnaire (disease-specific quality of life measure)* 3.4. EuroQol questionnaire 3.5. Patient satisfaction 3.6. Number of sessions of injection Sclerotherapy as required* 3.7. Duplex assessment * = Primary endpoint measurements
Intervention type	Other
Primary outcome measure(s)	Sclerotherapy requirement at follow up: disease specific quality of life improvement measured by Aberdeen varicose vein severity score.
Key secondary outcome measure(s)	1. Post-procedure pain: patient analgesia diary 2. Cosmesis: as scored by the patient 3. Complication rates: wound infection, haematoma, nerve injury, DVT 4. Patient satisfaction
Completion date	15/05/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	69
Key inclusion criteria	Patients with primary varicose veins in the leg due to isolated incompetent sapheno-femoral junction and great saphenous vein reflux both above and below knee segments.
Key exclusion criteria	1. Recurrent varicose veins 2. Patients with reflux in other axial veins 3. Patients with varicose veins only in thigh 4. Patients who has no reflux in below-knee segment of great saphenous vein
Date of first enrolment	10/11/2005
Date of final enrolment	15/05/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Leeds Vascular Institute

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