Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

• ClinicalTrials.gov Identifier: NCT01701661
• Recruitment Status: Completed
• First Posted: October 5, 2012
• Last Update Posted: October 5, 2012
• Sponsor: Helsinki University Central Hospital
• Information provided by (Responsible Party): Maarit Venermo, Helsinki University Central Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Venous Insufficiency	Procedure: Operative treatment; Other: conservative treatment	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial
• Study Start Date: September 2004
• Actual Primary Completion Date: October 2008
• Actual Study Completion Date: September 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: conservative treatment; Compression stockings class II	Other: conservative treatment; Compression stockings class II
Active Comparator: Operative treatment; stripping of main trunk or if previously removed, removal or ligating the refloating trunk	Procedure: Operative treatment; stripping of main trunk or if previously removed, removal or ligating the refluating trunk

Outcome Measures

Primary Outcome Measures :

1. Symptom relief [ Time Frame: 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 :

1. Quality of life [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Finland

Department of Vascular Surgery, Helsinki University Central Hospital

Helsinki, HUS, Finland, 00029

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

• Principal Investigator: Maarit Venermo, MD,PhD; Department of Vascular Surgery, Helsinki University Central Hospital

More Information

• Responsible Party: Maarit Venermo, MD,PhD, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT01701661
• Other Study ID Numbers: TYH4209
• First Posted: October 5, 2012
• Last Update Posted: October 5, 2012
• Last Verified: October 2012

Keywords provided by Maarit Venermo, Helsinki University Central Hospital:

venous surgery; compression therapy

Additional relevant MeSH terms:

Venous Insufficiency; Vascular Diseases; Cardiovascular Diseases