Varicose Veins
Conditions
Keywords
Varicose veins, Compression stockings, Sclerotherapy, Radiofrequency ablation
Brief summary
Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II)
Detailed description
In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group. Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage. Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.
Interventions
Sponsors
Oulu University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more) * Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4 * Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation
Exclusion criteria
* History of pulmonary embolism or deep venous thrombosis * Large (\>12mm) truncal vein diameter * CEAP C5-C6 * Patient unwilling to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Truncal vein occlusion rate | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Painkillers usage after treatment | 10 days | Need for Paracetamol/NSAIDs after treatment |
| Aberdeen Varicose Veins Questionnaire (AVVQ) | 6 months | Assessed preoperatively and at one and six months |
| Post-operative pain assessed with visual analogue scale (VAS) | 10 days | — |
| Time required returning to normal work and activity level | 14 days | — |
| Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively | 30days | Assessed in 1month control and earlier if necessary (Patient is instructed to contact outpatient clinic in case of problems). |
| Compliance with compression stockings | 7 days | To assess compliance and possible reasons for non-compliance at compression group |
Countries
Finland
Outcome results
None listed