Delayed or Immediate Local Treatment of Veins

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-04

Study Completion Date

2022-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Varicose Veins Leg

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate phlebectomy

Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities

Group Type ACTIVE_COMPARATOR

Immediate phlebectomy

Intervention Type PROCEDURE

See arm description

Delayed treatment

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

Group Type EXPERIMENTAL

Delayed sclerotherapy

Intervention Type PROCEDURE

See arm descriptions

Interventions

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Delayed sclerotherapy

See arm descriptions

Intervention Type PROCEDURE

Immediate phlebectomy

See arm description

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No