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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02397226

Enrollment

198

Registered

2015-03-24

Start date

2014-09-01

Completion date

2026-12-31

Last updated

2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Veins, Venous Insufficiency

Keywords

Radiofrequency ablation, Plethysmography, Duplex ultrasound, High ligation/stripping

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).

Interventions

PROCEDURERadiofrequency ablation

PROCEDUREHigh ligation/stripping

DEVICERadiofrequency ablation catheter

PROCEDURETumescent anesthesia

PROCEDUREGeneral anesthesia

DEVICEVein stripping catheter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of treated limbs with neovascularization using duplex and/or plethysmography.	5 years	—
Number of treated veins with recanalization using duplex.	5 years	Flow detected by duplex at the site of the treated vein.
Prediction of treatment outcome using plethysmography with superficial shut-down.	1 month postoperatively	If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.

Secondary

Measure	Time frame	Description
VCSS score	5 years	The score of standardized examination protocol VCSS.
AVVQ score	5 years	The score of disease specific questionnaire AVVQ
EQ-5D score	5 years	The score of EQ-5D questionnaire

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026