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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation | Active Comparator | Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia. |
|
| High ligation/stripping | Active Comparator | Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Procedure |
| ||
| High ligation/stripping |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treated veins with recanalization using duplex. | Flow detected by duplex at the site of the treated vein. | 5 years |
| Number of treated limbs with neovascularization using duplex and/or plethysmography. | 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. | 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| VCSS score | The score of standardized examination protocol VCSS. | 5 years |
| AVVQ score | The score of disease specific questionnaire AVVQ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helene Zachrisson, Associate Professor, MD | Linkoeping University | Study Chair |
| Oskar Nelzén, MD | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Linköping | Linköping | Östergötland County | 58185 | Sweden | ||
| Vrinnevisjukhuset |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31959059 | Derived | Nelzen POE, Skoog J, Oster M, Zachrisson H. Impact on venous haemodynamics after treatment of great saphenous vein incompetence using plethysmography and duplex ultrasound. Phlebology. 2020 Aug;35(7):495-504. doi: 10.1177/0268355519898952. Epub 2020 Jan 20. |
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| Procedure |
|
|
| Radiofrequency ablation catheter | Device |
|
|
| Tumescent anesthesia | Procedure |
|
| General anesthesia | Procedure |
|
| Vein stripping catheter | Device |
|
| 5 years |
| EQ-5D score | The score of EQ-5D questionnaire | 5 years |
| Norrköping |
| Östergötland County |
| 60379 |
| Sweden |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D061887 | Conversion to Open Surgery |
| D017115 | Catheter Ablation |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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