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| 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 |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN31316759 |
| Date ISRCTN assigned | 26/07/2007 |
| Local reference number(s) | N/A |
| Public title | 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 |
| Scientific title | |
| Acronym | Leeds EVLA technique trial |
| Disease/condition/study domain | Varicose veins |
| Study hypothesis | Modified techniques reduces requirement of delayed foam sclerotherapy and provides better clinical outcome. |
| Design/methodology | Randomised controlled trial (not blinded) |
| Research ethics review | Approved on 21st September 2005 by Leeds (West) research ethics committee, at Leeds General Infirmary, Leeds (ref: 05/Q1205/187). |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 10/11/2005 |
| Anticipated end date | 15/05/2007 |
| Status of trial | Completed |
| Target number of participants | 69 participants |
| Interventions | 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 |
| Primary outcome measure(s) | Sclerotherapy requirement at follow up: disease specific quality of life improvement measured by Aberdeen varicose vein severity score. |
| 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 |
| Sources of funding | Leeds Vascular Institute (UK) - Research Fund |
| Sponsor name | Leeds General Infirmary (UK) |
| Sponsor details | c/o Mr M.J. Gough Great George Street Leeds United Kingdom LS1 3EX |
| Sponsor telephone | +44 (0)113 392 2823 |
| Sponsor fax | +44 (0)113 392 2624 |
| Sponsor email | michael.gough@leedsth.nhs.uk |
| Sponsor website | http://www.leedsteachinghospitals.com/ |
| Contact name | Mr Nadarajah Theivacumar |
| Contact details | Leeds Vascular Institute Leeds General Infirmary Great George Street Leeds United Kingdom LS1 3EX |
| Contact telephone | +44 (0)7940 774550 |
| Contact fax | +44 (0)113 392 2624 |
| Contact email | nadacumar@yahoo.co.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN31316759 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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