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 |
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DOI | https://doi.org/10.1186/ISRCTN31316759 |
Secondary identifying numbers | N/A |
- 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
Scientific
Leeds Vascular Institute
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Phone | +44 (0)7940 774550 |
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nadacumar@yahoo.co.uk |
Study information
Study design | Randomised controlled trial (not blinded) |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 10/11/2005 |
Completion date | 15/05/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 69 participants |
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
- England
- United Kingdom
Study participating centre
Leeds Vascular Institute
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Leeds General Infirmary (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Mr M.J. Gough
Great George Street
Leeds
LS1 3EX
England
United Kingdom
Phone | +44 (0)113 392 2823 |
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michael.gough@leedsth.nhs.uk | |
Website | http://www.leedsteachinghospitals.com/ |
https://ror.org/04hrjej96 |
Funders
Funder type
Research organisation
Leeds Vascular Institute (UK) - Research Fund
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/07/2008 | Yes | No |