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

Not Applicable

Active, not recruiting

• Conditions: Venous Insufficiency; Varicose Veins

• 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

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)

University Hospital Linköping; 🇸🇪 Linköping, Östergötland, Sweden

Vrinnevisjukhuset; 🇸🇪 Norrköping, Östergötland, Sweden