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

Not Applicable

Active, not recruiting

• Conditions: Venous Insufficiency; Varicose Veins
• Interventions: Procedure: Radiofrequency ablation; Procedure: High ligation/stripping; Device: Radiofrequency ablation catheter; Procedure: General anesthesia; Device: Vein stripping catheter; Procedure: Tumescent anesthesia

• Registration Number: NCT02397226
• Lead Sponsor: University Hospital, Linkoeping

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-01
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-24
• Primary Completion: 2021-11-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 198

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High ligation/stripping	Vein stripping catheter	Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia.
Radiofrequency ablation	Radiofrequency ablation	Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia.
Radiofrequency ablation	Radiofrequency ablation catheter	Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia.
Radiofrequency ablation	Tumescent anesthesia	Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia.
High ligation/stripping	High ligation/stripping	Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia.
High ligation/stripping	General anesthesia	Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia.

Primary Outcome Measures

Name	Time	Method
Number of treated veins with recanalization using duplex.	5 years	Flow detected by duplex at the site of the treated vein.
Number of treated limbs with neovascularization using duplex and/or plethysmography.	5 years
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Vrinnevisjukhuset; 🇸🇪 Norrköping, Östergötland, Sweden

University Hospital Linköping; 🇸🇪 Linköping, Östergötland, Sweden