Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maarit Venermo, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01701661
First received: October 3, 2012
Last updated: October 4, 2012
Last verified: October 2012

October 3, 2012
October 4, 2012
September 2004
October 2008   (final data collection date for primary outcome measure)
Symptom relief [ Time Frame: two years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01701661 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: two years ] [ Designated as safety issue: No ]
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).
Same as current
Not Provided
Not Provided
 
Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux
Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Insufficiency
  • Procedure: Operative treatment
    stripping of main trunk or if previously removed, removal or ligating the refluating trunk
  • Other: conservative treatment
    Compression stockings class II
  • Active Comparator: conservative treatment
    Compression stockings class II
    Intervention: Other: conservative treatment
  • Active Comparator: Operative treatment
    stripping of main trunk or if previously removed, removal or ligating the refloating trunk
    Intervention: Procedure: Operative treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
September 2012
October 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01701661
TYH4209
No
Maarit Venermo, Helsinki University Central Hospital
Helsinki University Central Hospital
Not Provided
Principal Investigator: Maarit Venermo, MD,PhD Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki University Central Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP