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NCT02397226 Clinical Trial

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

Varicose Veins Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02397226
Other study ID # Varicerstudien
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2014
Est. completion date December 31, 2026

Study information
Verified date May 2023
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 198
Est. completion date December 31, 2026
Est. primary completion date November 25, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Radiofrequency ablation

• High ligation/stripping

Device:
• Radiofrequency ablation catheter

Procedure:
• Tumescent anesthesia

• General anesthesia

Device:
• Vein stripping catheter

Locations
Country Name City State
Sweden University Hospital Linköping Linköping Östergötland
Sweden Vrinnevisjukhuset Norrköping Östergötland

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of treated veins with recanalization using duplex. Flow detected by duplex at the site of the treated vein. 5 years
Primary Number of treated limbs with neovascularization using duplex and/or plethysmography. 5 years
Primary 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. 1 month postoperatively
Secondary VCSS score The score of standardized examination protocol VCSS. 5 years
Secondary AVVQ score The score of disease specific questionnaire AVVQ 5 years
Secondary EQ-5D score The score of EQ-5D questionnaire 5 years
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