Delayed or Immediate Local Treatment of Veins (DELICATVE)

Helsinki University Central Hospital (HUCH)

Status: Active, not recruiting

Conditions: Varicose Veins Leg

Treatments: Procedure: Immediate phlebectomy; Procedure: Delayed sclerotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03340246

DELICATVE

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Immediate phlebectomy

Active Comparator group

Description:

Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities

Treatment:

Procedure: Immediate phlebectomy

Delayed treatment

Experimental group

Description:

Mechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required

Treatment:

Procedure: Delayed sclerotherapy