Varicose Veins, Varicose Veins of Lower Limb
Conditions
Keywords
Varicose veins, Compression stockings, Sclerotherapy, Radiofrequency ablation
Brief summary
Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group (Group II)
Interventions
Patients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime
Sponsors
Oulu University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Duplex ultrasound verified GSV, AASV and/or SSV incompetence suitable for radiofrequency ablation * Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4 * Distal varicose vein insufficiency suitable for sclerotherapy * Patient willingness to participate
Exclusion criteria
* History of pulmonary embolism or deep venous thrombosis * Large (\>12mm) truncal vein diameter * CEAP C5-C6 * Antithrombotic medication (ASA accepted)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 10days recorded daily | Visual Analog Scale (VAS) 0-100mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aberdeen Varicose Veins Questionnaire (AVVQ) | Assessed preoperatively and at 2 months | Score from 0 to 99.658 |
| Visual appearance of varicose veins, patient assessment | Preoperatively and at 2 months | Patient self-assessment (Patient Self-Assessment of Visible Varicose Veins, PA-V score) |
| Signs of deep venous thrombosis hematoma | Assessed at 2 months and earlier if necessary | Ultrasound assessment |
| Functional ability, other than pain | 10 days recorded daily | Visual Analog Scale 0-100mm indicating post-operative functional ability reduction |
| Time required returning to full activity | 14 days | — |
| Postoperative pigmentation | at 2 months | Pigmentation is monitored from standardised photographs on severity of pigmentation and most severe tone of post-operative pigmentation compared to base skin colour, reviewers are blinded to study group. |
| Visual appearance of varicose veins, expert assessment | Preoperatively and at 2 months | Photography Review -Visible Varicose Veins (IPR-V score, reviewers are blinded to time point and study group). |
| Time required returning to normal activity | 14 days | — |
Countries
Finland
Outcome results
None listed