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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Varicose Veins
• Venous Insufficiency

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