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

University Hospital, Linkoeping

Status: Active, not recruiting

Conditions: Venous Insufficiency; Varicose Veins

Treatments: Procedure: Tumescent anesthesia; Procedure: General anesthesia; Procedure: Radiofrequency ablation; Device: Vein stripping catheter; Device: Radiofrequency ablation catheter; Procedure: High ligation/stripping

Study type: Interventional

Funder types: Other

Identifiers

NCT02397226

Varicerstudien

Details and patient eligibility

About

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).

Enrollment: 198 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Radiofrequency ablation

Active Comparator group

Description:

Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia.

Treatment:

Device: Radiofrequency ablation catheter

Procedure: Radiofrequency ablation

Procedure: Tumescent anesthesia

High ligation/stripping

Active Comparator group

Description:

Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia.

Treatment:

Procedure: High ligation/stripping

Device: Vein stripping catheter

Procedure: General anesthesia