Varicose Veins
Conditions
Brief summary
This study will be comparing the treatment of varicose vein tributaries using either foam sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their saphenous vein. The re-intervention rates, safety, patient experience as well as the cost effectiveness of each intervention will be assessed.
Interventions
PROCEDUREAmbulatory phlebectomy
Minor surgery to remove varicose vein tributaries
Injection of foam sclerosant into varicose vein tributaries
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over 18 years of age * Symptomatic GSV or SSV vein reflux \> 0.5 seconds on colour Duplex * Varicose vein tributary requiring treatment
Exclusion criteria
* Current DVT * Recurrent varicose veins * Arterial disease (ABPI\<0.8) * Vein diameter \< 3mm * Preference for one of the treatment options * Patient who are unwilling to participate * Inability or unwillingness to complete questionnaires * Inability to attend follow-up appointments * Patient currently included in a study of varicose vein treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-intervention rate | 12 months | Re-intervention on varicose vein tributaries during study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generic quality of life score | 12 months | Quality of life score using the EuroQol's EQ-5D \[0=worse quality of life; 1=best quality of life\] |
| Disease-specific quality of life score | 12 months | Quality of life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) \[0=worse quality of life; 100= best quality of life\] |
| Disease specific quality of life score | 12 months | Quality of life score using the ChronIc Venous Insufficiency Quality of Life Questionnaire (CIVIQ) \[0=worse quality of life; 100=best quality of life\] |
| Clinical score | 12 months | Clinical change using the Venous Clinical Severity Score (VCSS) \[0=least severe disease; 30=most severe disease\] |
| Pain score over the first 10 days | 2 weeks | Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain) |
| Degree of bruising at 2 weeks | 2 weeks | Degree of bruising at 2 weeks using a categorical 0-5 bruising scale (0=no bruising; 5=bruising extending beyond treated segment) |
| Time to return to normal activities | 2 weeks | — |
Countries
United Kingdom
Contacts
Primary ContactAmjad Belramman
Backup ContactRoshan Bootun
Outcome results
None listed