Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

Study Overview
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Brief Summary
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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
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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.

Official Title
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Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Procedure: Operative treatment
* Other: conservative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conservative treatment<br>Compression stockings class II | Other: conservative treatment<br>* Compression stockings class II<br>|
| Active Comparator: Operative treatment<br>stripping of main trunk or if previously removed, removal or ligating the refloating trunk | Procedure: Operative treatment<br>* stripping of main trunk or if previously removed, removal or ligating the refluating trunk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom relief | 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. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | 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). | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous surgery, compression therapy