Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

NCT ID: NCT01701661

Last Updated: 2012-10-05

Basic Information

• 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

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.

Conditions

Venous Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

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

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maarit Venermo

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maarit Venermo, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular Surgery, Helsinki University Central Hospital

Locations

Department of Vascular Surgery, Helsinki University Central Hospital

Helsinki, HUS, Finland

Countries

Finland

Other Identifiers

TYH4209

Identifier Type: -

Identifier Source: org_study_id