Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01701661
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
Maarit Venermo, Helsinki University Central Hospital

Tracking Information
First Submitted Date  ICMJE October 3, 2012
First Posted Date  ICMJE October 5, 2012
Last Update Posted Date October 5, 2012
Study Start Date  ICMJE September 2004
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux
Official Title  ICMJE Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Venous Insufficiency
Intervention  ICMJE
  • Procedure: Operative treatment
    stripping of main trunk or if previously removed, removal or ligating the refluating trunk
  • Other: conservative treatment
    Compression stockings class II
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2012)
153
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01701661
Other Study ID Numbers  ICMJE TYH4209
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maarit Venermo, Helsinki University Central Hospital
Study Sponsor  ICMJE Helsinki University Central Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maarit Venermo, MD,PhD Department of Vascular Surgery, Helsinki University Central Hospital
PRS Account Helsinki University Central Hospital
Verification Date October 2012

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