Delayed or Immediate Local Treatment of Veins

Not Applicable

• Conditions: Varicose Veins Leg
• Interventions: Procedure: Immediate phlebectomy; Procedure: Delayed sclerotherapy

• Registration Number: NCT03340246
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-04
• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Primary Completion: 2020-12-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate phlebectomy	Immediate phlebectomy	Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities
Delayed treatment	Delayed sclerotherapy	Mechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required

Primary Outcome Measures

Name	Time	Method
Need for sclerotherapy	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Occlusion rate of great saphenous vein	36 months	Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound.
Patient satisfaction	3 months	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.

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland