Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery

N/AActive Not RecruitingNCT02397226

University Hospital, Linkoeping198 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

198

Conditions

Varicose Veins Venous Insufficiency

Interventions

Radiofrequency ablationPROCEDURE

High ligation/strippingPROCEDURE

Radiofrequency ablation catheterDEVICE

Tumescent anesthesiaPROCEDURE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

University Hospital Linköping

Linköping, Östergötland County, Sweden

Vrinnevisjukhuset

Norrköping, Östergötland County, Sweden

Outcomes

Primary Outcomes

Number of treated veins with recanalization using duplex.

Flow detected by duplex at the site of the treated vein.

Time frame: 5 years

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.

If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.

Time frame: 1 month postoperatively

Secondary Outcomes

VCSS score

The score of standardized examination protocol VCSS.

Time frame: 5 years

AVVQ score

The score of disease specific questionnaire AVVQ

Time frame: 5 years

EQ-5D score

The score of EQ-5D questionnaire

Time frame: 5 years

Data from ClinicalTrials.gov

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