An interventional study of Radiofrequency ablation and High ligation/stripping in Varicose Veins and Venous Insufficiency, sponsored by University Hospital, Linkoeping. Active, not recruiting at 2 sites in Sweden. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by University Hospital, Linkoeping · Not applicable, Interventional, and Treatment
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).
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's enrollment of 198 is above the median of 60 across 139 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →University Hospital, Linkoeping is the lead sponsor of 118 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia.
Procedure: Radiofrequency ablation · Device: Radiofrequency ablation catheter · Procedure: Tumescent anesthesia
Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia.
Procedure: High ligation/stripping · Procedure: General anesthesia · Device: Vein stripping catheter
Also known as: Open surgery
Also known as: Covidien ClosureFast Catheter (7cm)
Number of treated veins with recanalization using duplex.
Flow detected by duplex at the site of the treated vein.
Time frame: 5 years
Number of treated limbs with neovascularization using duplex and/or plethysmography.
Time frame: 5 years
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.
Time frame: 1 month postoperatively
VCSS score
The score of standardized examination protocol VCSS.
Time frame: 5 years
AVVQ score
The score of disease specific questionnaire AVVQ
Time frame: 5 years
EQ-5D score
The score of EQ-5D questionnaire
Time frame: 5 years
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Linkoeping