<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01701661</url>
  </required_header>
  <id_info>
    <org_study_id>TYH4209</org_study_id>
    <nct_id>NCT01701661</nct_id>
  </id_info>
  <brief_title>Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux</brief_title>
  <official_title>Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized controlled trial, a method used to implement the random allocation sequence is&#xD;
      numbered containers.&#xD;
&#xD;
      The aim of the study is to compare compression therapy with compression stockings and surgery&#xD;
      eliminating superficial venous reflux in patients with duplex ultrasound verified superficial&#xD;
      venous reflux without skin changes or ulceration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Superficial venous reflux is common in adult population. Uncomplicated disease, where there&#xD;
      is no skin changes but varicose veins with or without leg swelling, can be totally&#xD;
      asymptomatic but also cause various symptoms as pain, aching and discomfort of leg usually&#xD;
      caused by increased venous pressure. Varicose veins may also cause cosmetic problem.&#xD;
      Compression stockings relief the symptoms as they normalize venous pressure. In surgical&#xD;
      treatment, axial reflux is treated usually by removing incompetent superficial veins. The aim&#xD;
      of the study is to compare conservative treatment with compression stockings with surgical&#xD;
      treatment of superficial venous reflux. In operative treatment the great saphenous vein or&#xD;
      lesser saphenous vein are removed after flush ligation by femoral vein and stripping of the&#xD;
      trunk. If the main trunk has been removes previously, axial refluating veins are removed or&#xD;
      ligated according to the DUS finding. The patients in both groups are examined at the&#xD;
      baseline and followed up to two years by ultrasound scanning. Patients clinical&#xD;
      classification, venous disability score, venous disease severity score, anatomical path of&#xD;
      reflux as well as quality of life are studied at the baseline, at one year follow-up and two&#xD;
      years follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2004</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">October 2008</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom relief</measure>
    <time_frame>two years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>two years</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Venous Insufficiency</condition>
  <arm_group>
    <arm_group_label>conservative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Compression stockings class II</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Operative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>stripping of main trunk or if previously removed, removal or ligating the refloating trunk</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Operative treatment</intervention_name>
    <description>stripping of main trunk or if previously removed, removal or ligating the refluating trunk</description>
    <arm_group_label>Operative treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conservative treatment</intervention_name>
    <description>Compression stockings class II</description>
    <arm_group_label>conservative treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with chronic superficial vein insufficiency&#xD;
&#xD;
          -  patient must be 20-70 years old&#xD;
&#xD;
          -  degree of difficulty of vein insufficiency C2-C3&#xD;
&#xD;
          -  venous disability score 1-2&#xD;
&#xD;
          -  patient is agreeable to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  peripheral atherosclerotic occlusive disease&#xD;
&#xD;
          -  lymphoedema&#xD;
&#xD;
          -  severe concomitant disease (ASA 3-5)&#xD;
&#xD;
          -  venous ulcers or unclassified skin changes&#xD;
&#xD;
          -  BMI more than 35&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maarit Venermo, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Vascular Surgery, Helsinki University Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Vascular Surgery, Helsinki University Central Hospital</name>
      <address>
        <city>Helsinki</city>
        <state>HUS</state>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>October 4, 2012</last_update_submitted>
  <last_update_submitted_qc>October 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Maarit Venermo</investigator_full_name>
    <investigator_title>MD,PhD</investigator_title>
  </responsible_party>
  <keyword>venous surgery</keyword>
  <keyword>compression therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venous Insufficiency</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01701661
org study id: TYH4209
nct id: NCT01701661
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Symptom relief
time frame: two years
description: 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.
measure: Quality of life
time frame: two years
description: 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).
arm group label: conservative treatment
arm group type: Active Comparator
description: Compression stockings class II
arm group label: Operative treatment
arm group type: Active Comparator
description: stripping of main trunk or if previously removed, removal or ligating the refloating trunk
intervention type: Procedure
intervention name: Operative treatment
description: stripping of main trunk or if previously removed, removal or ligating the refluating trunk
arm group label: Operative treatment
intervention type: Other
intervention name: conservative treatment
description: Compression stockings class II
arm group label: conservative treatment
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Maarit Venermo, MD,PhD
role: Principal Investigator
affiliation: Department of Vascular Surgery, Helsinki University Central Hospital
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Maarit Venermo
investigator title: MD,PhD
mesh term: Venous Insufficiency