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Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism.
This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate phlebectomy | Active Comparator | Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities |
|
| Delayed treatment | Experimental | Mechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed sclerotherapy | Procedure | See arm descriptions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Need for sclerotherapy | Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. >C2 will be eligible for treatment. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Overall patient satisfaction and symptoms regarding varicosities and procedure at three months. Evaluated by the Aberdeen Varicose Veins Questionnaire (AVVQ). The AVVQ is a validated test, in which patients are asked to check boxes with regard to symptoms and quality of life (QoL). Scale 0-100, with 100 indicating worst possible QoL. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karoliina Halmesmäki, M.D., Ph.D | Helsinki University Central Hospital | Principal Investigator |
| Maarit Venermo, M.D., Ph.D. | Helsinki University Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | 00029 | Finland |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Immediate phlebectomy |
| Procedure |
See arm description |
|
| Occlusion rate of great saphenous vein | Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound. | 36 months |