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| Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins |
| Source of record | UK Trials |
| ISRCTN | ISRCTN51995477 |
| Date ISRCTN assigned | 29/02/2008 |
| Local reference number(s) | HTA 06/45/02 |
| Public title | Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Varicose veins |
| Study hypothesis | Foam sclerotherapy is more cost-effective in terms of incremental cost per quality adjusted life year compared to surgery or laser therapy |
| Design/methodology | Randomised controlled trial |
| Research ethics review | To be submitted as of 25/02/2008 |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Adult patients (aged over 18 years old) 2. Those who are referred to the surgical out-patient department for treatment of primary varicose veins with symptomatic (CEAP [Clinical, Etiological, Anatomical, Pathological elements] classification grade 2 or above) primary long or short saphenous main stem incompetence (reflux >1 second on duplex scanning) 3. Suitable for day case treatment |
| Participants - exclusion criteria | 1. Current deep vein thrombosis 2. Deep venous incompetence 3. Acute superficial vein thrombosis 4. Allergy to sclerosant 5. Pregnancy or breast feeding 6. History of hypercoagulability 7. Arterial disease (ankle brachial pressure index <0.8) 8. Inability to mobilise post-procedure 9. Needle phobia 10. Long or short saphenous vein less than 3 mm in diameter or greater than 15 mm and tortuous veins that are considered to be unsuitable for endovenous laser ablation (EVLA) due to difficulties in passing the guide wire 11. Inability to complete study questionnaires |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/06/2008 |
| Anticipated end date | 31/05/2011 |
| Status of trial | Ongoing |
| Target number of participants | 1,015 |
| Interventions | Arm 1: Foam sclerotherapy Arm 2: Foam sclerotherapy + endovenous laser therapy Arm 3: Conventional surgery |
| Primary outcome measure(s) | The following will be assessed at 6 months: Primary patient outcome: 1. Disease specific: Aberdeen Varicose Vein Questionnaire 2. Generic: EuroQol (EQ-5D), the 36-item Short Form health survey (SF-36) Primary economic outcome: 3. Incremental cost per quality adjusted life year (QALY) |
| Secondary outcome measure(s) | 1. Costs to the health service and patients and any subsequent care 2. Technical success of venous intervention at 6 weeks and 6 months 3. Clinical success of venous intervention at 6 weeks and 6 months 4. Disease specific and generic quality of life at 6 weeks 5. Behavioural recovery |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of Aberdeen (UK) |
| Sponsor details | c/o Dr E Rattray Research & Innovation University Office Kings College Aberdeen United Kingdom AB24 3FX |
| Sponsor website | http://www.abdn.ac.uk |
| Contact name | Dr Julie Brittenden |
| Contact details | c/o Vascular Department Ward 36 Aberdeen Royal Infirmary Foresterhill Aberdeen United Kingdom AB25 2ZN |
| Contact email | j.brittenden@abdn.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN51995477 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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