Contact information
Type
Scientific
Primary contact
Mr Nadarajah Theivacumar
ORCID ID
Contact details
Leeds Vascular Institute
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)7940 774550
nadacumar@yahoo.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Leeds EVLA technique trial
Study hypothesis
Modified techniques reduces requirement of delayed foam sclerotherapy and provides better clinical outcome.
Ethics approval
Leeds (West) research ethics committee, at Leeds General Infirmary on 21/09/2005 (ref: 05/Q1205/187)
Study design
Randomised controlled trial (not blinded)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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following which 5 ml 1% STD (2 ml 1% STD, 3 ml air) will be injected into the below knee GSV via the sheath as it was withdrawn.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
Phase
Not Specified
Drug names
Primary outcome measure
Sclerotherapy requirement at follow up: disease specific quality of life improvement measured by Aberdeen varicose vein severity score.
Secondary outcome measures
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
Overall trial start date
10/11/2005
Overall trial end date
15/05/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
69 participants
Participant 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
Recruitment start date
10/11/2005
Recruitment end date
15/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Vascular Institute
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Leeds General Infirmary (UK)
Sponsor details
c/o Mr M.J. Gough
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 2823
michael.gough@leedsth.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Leeds Vascular Institute (UK) - Research Fund
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18440756
Publication citations
-
Results
Theivacumar NS, Dellagrammaticas D, Mavor AI, Gough MJ, Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial., J. Vasc. Surg., 2008, 48, 1, 173-178, doi: 10.1016/j.jvs.2008.01.062.