Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. A 5-year Follow-up Using Duplex Ultrasound, Plethysmography, VCSS, AVVQ and EQ-5D
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 198
- Locations
- 4
- Primary Endpoint
- Number of treated veins with recanalization using duplex.
Study Overview
Brief Summary
200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Insufficient great saphenous vein
- •Possible to treat with both radiofrequency ablation and high ligation/stripping
- •Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6
Exclusion Criteria
- •Previous intervention in the affected leg
- •Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein.
- •Small saphenous vein insufficiency with diameter >6 mm and/or flow >100ml/min
- •Patient that is not able to perform plethysmography
Outcomes
Primary Outcomes
Number of treated veins with recanalization using duplex.
Time Frame: 5 years
Flow detected by duplex at the site of the treated vein.
Number of treated limbs with neovascularization using duplex and/or plethysmography.
Time Frame: 5 years
Prediction of treatment outcome using plethysmography with superficial shut-down.
Time Frame: 1 month postoperatively
If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.
Secondary Outcomes
- VCSS score(5 years)
- AVVQ score(5 years)
- EQ-5D score(5 years)
Investigators
Oskar Nelzén
MD, PhD
University Hospital, Linkoeping