Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701661
• Other study ID #: TYH4209
• Status: Completed
• Phase: N/A
• First received: October 3, 2012
• Last updated: October 4, 2012
• Start date: September 2004
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: September 2012
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Procedure:
• Operative treatment
stripping of main trunk or if previously removed, removal or ligating the refluating trunk

Other:
• conservative treatment
Compression stockings class II

Locations

Country	Name	City	State
Finland	Department of Vascular Surgery, Helsinki University Central Hospital	Helsinki	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No