Cardiovascular: Varicose veins Circulatory System Varicose veins
Conditions
Interventions
Randomisation and Blinding:
Randomisation will be computer generated using the Statistical Package for Social Sciences (SPSS) and shall occur only once informed consent has been obtained and followi
Sponsors
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Eligibility
Inclusion criteria
Inclusion criteria: All patients with primary or recurrent, uni or bilateral varicose veins with clinical evidence of saphenofemoral incompetence and who fulfill the following criteria will be considered eligible for the trial: 1. Clinically fit for general anaesthesia 2. Have the need for saphenofemoral junction ligation during varicose vein surgery 3. Should have the legal age and ability to provide informed consent 4. Have no known allergies to the products being tested 5. Agree to their GP being informed of their participation
Exclusion criteria
Exclusion criteria: 1. Patients not able or unwilling to provide informed consent 2. Undergoing formal anti-coagulation for previous thromboembolic phenomena 3. Known allergies to the products being investigated 4. Do not agree to their GP being informed of their participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study shall be designed to demonstrate a 50% reduction in the clinical presence of recurrence at 5 years. Therefore, the null hypothesis is that no statistically significant difference exists in the clinically assessed recurrence rates at 5 years between PermacolTM and standard surgical groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Annual clinical recurrence rates 2. Radiographically demonstrable recurrence rates at 1 year and 5 years 3. Visual analogue pain scores 4. SF36 and EUROQOL questionnaire scores 5. Local complication rate: fistula, haematoma, groin wound infection 6. Serious adverse event rates | — |
Countries
United Kingdom
Outcome results
None listed