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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03340246
Other study ID # DELICATVE
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 4, 2016
Est. completion date December 31, 2022

Study information

Verified date August 2022
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140
Est. completion date December 31, 2022
Est. primary completion date December 20, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - Ultrasound verified insufficiency of great saphenous vein (GSV) - GSV diameter 5-10 mm - C2-C4 varicosities - Most proximal insufficient branch in the distal thigh - Written and signed informed consent Exclusion Criteria: - Peripheral arterial disease - Body mass index >40 - Lymphoedema - Known allergy to sclerosant - Any known coagulopathy or history of deep vein thrombosis - Severe illness - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Delayed sclerotherapy
See arm descriptions
Immediate phlebectomy
See arm description

Locations

Country Name City State
Finland Helsinki University Hospital Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Occlusion rate of great saphenous vein Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound. 36 months
See also
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