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Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

NCT ID: NCT01701661

Last Updated: 2012-10-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2012-09-30

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.

Conditions

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Venous Insufficiency

Keywords

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venous surgery compression therapy

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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conservative treatment

Compression stockings class II

Group Type ACTIVE_COMPARATOR

conservative treatment

Intervention Type OTHER

Compression stockings class II

Operative treatment

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

Group Type ACTIVE_COMPARATOR

Operative treatment

Intervention Type PROCEDURE

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

Interventions

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Operative treatment

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

Intervention Type PROCEDURE

conservative treatment

Compression stockings class II

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maarit Venermo

MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maarit Venermo, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular Surgery, Helsinki University Central Hospital

Locations

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Department of Vascular Surgery, Helsinki University Central Hospital

Helsinki, HUS, Finland

Site Status

Countries

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Finland

Other Identifiers

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TYH4209

Identifier Type: -

Identifier Source: org_study_id