Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Venous Insufficiency

Treatments: Other: conservative treatment; Procedure: Operative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01701661

TYH4209

Details and patient eligibility

About

Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.

The aim of the study is to compare compression therapy with compression stockings and surgery eliminating superficial venous reflux in patients with duplex ultrasound verified superficial venous reflux without skin changes or ulceration.

Full description

Superficial venous reflux is common in adult population. Uncomplicated disease, where there is no skin changes but varicose veins with or without leg swelling, can be totally asymptomatic but also cause various symptoms as pain, aching and discomfort of leg usually caused by increased venous pressure. Varicose veins may also cause cosmetic problem. Compression stockings relief the symptoms as they normalize venous pressure. In surgical treatment, axial reflux is treated usually by removing incompetent superficial veins. The aim of the study is to compare conservative treatment with compression stockings with surgical treatment of superficial venous reflux. In operative treatment the great saphenous vein or lesser saphenous vein are removed after flush ligation by femoral vein and stripping of the trunk. If the main trunk has been removes previously, axial refluating veins are removed or ligated according to the DUS finding. The patients in both groups are examined at the baseline and followed up to two years by ultrasound scanning. Patients clinical classification, venous disability score, venous disease severity score, anatomical path of reflux as well as quality of life are studied at the baseline, at one year follow-up and two years follow-up.

Enrollment: 153 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with chronic superficial vein insufficiency
• patient must be 20-70 years old
• degree of difficulty of vein insufficiency C2-C3
• venous disability score 1-2
• patient is agreeable to the study

Exclusion criteria

• peripheral atherosclerotic occlusive disease
• lymphoedema
• severe concomitant disease (ASA 3-5)
• venous ulcers or unclassified skin changes
• BMI more than 35

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

conservative treatment

Active Comparator group

Description:

Compression stockings class II

Treatment:

Other: conservative treatment

Operative treatment

Active Comparator group

Description:

stripping of main trunk or if previously removed, removal or ligating the refloating trunk

Treatment:

Procedure: Operative treatment