Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

Not Applicable

Completed

• Conditions: Venous Insufficiency
• Interventions: Other: conservative treatment; Procedure: Operative treatment

• Registration Number: NCT01701661
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2008-10
• Study Completion: 2012-09
• Status Verified: 2012-10
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-04
• Last Update Submitted: 2012-10-04
• Study First Posted: 2012-10-05
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conservative treatment	conservative treatment	Compression stockings class II
Operative treatment	Operative treatment	stripping of main trunk or if previously removed, removal or ligating the refloating trunk

Primary Outcome Measures

Name	Time	Method
Symptom relief	two years	Patients are examined at the baseline, one and 2-year follow-up and the following measures are compared: clinical classification, venous disability score, venous disease severity score, reflux according to ultrasound examination.

Secondary Outcome Measures

Name	Time	Method
Quality of life	two years	Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life).

Trial Locations

Locations (1)

Department of Vascular Surgery, Helsinki University Central Hospital; 🇫🇮 Helsinki, HUS, Finland