New Compression Hosiery Versus Standard Class II Compression Stockings After Endothermal Ablation
Condition: Varicose Veins; Vascular Diseases
MeSH terms: Vascular Diseases; Varicose Veins
Study type: Interventional

Summary: 
      A prospective comparative randomized multicentre non-inferiority trial. The purpose of this
      study is to compares of a short compression hosiery (stocking without a foot, compression
      class 2) with standard compression class 2 stockings for 7 days after the endovascular
      radiofrequency ablation of great saphenous vein with phlebectomy varicose tributaries.
    

Detailed description: 
      It is common practice to use compression hosiery in the postoperative period to reduce pain,
      swelling, ecchymosis and hematoms. Long-term compression therapy is associated with a number
      of inconveniences, which leads to a decrease in compliance and violation of the patient's
      appointed treatment schedule. The use of short compression stoking can improve the compliance
      to applying of compression in a round-the-clock mode while maintaining the effectiveness of
      therapy.

      The aim of the study The purpose of this study is to compare a short compression hosiery
      (stocking without a foot, compression class 2) with standard compression class 2 stockings
      for 7 days after the endovascular radiofrequency ablation of great saphenous vein with
      phlebectomy varicose tributaries.

      Materials and methods A Multicenter Randomized Controlled Non-inferiority Trial. The study
      compares the effectiveness of a short compression hosiery (stocking without a foot,
      compression class 2) with standard compression class 2 stockings for 7 days after the
      endovascular radiofrequency ablation of great saphenous vein with phlebectomy varicose
      tributaries.

      The study includes patients who are scheduled for the radiofrequency ablation of the great
      saphenous vein and phlebectomy varicose tributaries (CEAP classification classes C2-C4).

      Endpoints in the study: the main outcome (primary endpoint) is the quality of life according
      to CIVIQ questionnaire on the 30th day after the intervention. Additional outcomes (secondary
      endpoints): comfort of using short compression stocking with the visual analog scale (VAS),
      pain level with the visual analogue scale (VAS), foot swelling. Registration of results for
      additional outcomes is conducted on days 1, 7, 14 and 30.

      The calculation of the sample size was made using the online calculator "Compare 2 Means: 2
      Sample Non Inferiority or Superiority" (https://goo.gl/8ND8CQ). The sample size was
      calculated taking into account the average values for the CIVIQ quality of life questionnaire
      on day 30 after the endovascular treatment obtained by reviewing the literature. Selected
      parameters: first-order error (α) 2.5%; power 80%; boundaries of "non-inferiority limit" 5;
      the expected difference between the study groups of 0. Taking into account the possible
      dropout of patients from the study, the size of the groups is increased by 10%. The estimated
      sample size is 164 participants. Randomization of patients into groups is carried out with
      the help of the system of randomization of the site "Register of methods for treatment of
      chronic disease."

      Statistical analysis. It is planned to conduct ITT - analysis (intentio-to-treat). For
      comparison, the primary and secondary outcomes will use nonparametric statistics
      (Mann-Whitney U-test).

      Discussion The main purpose of this study is to evaluate the effectiveness of a new type of
      compression hosiery of a Russian manufacturer. The main hypotheses of the study: 1) it is
      expected that the absence of a "foot" in hosiery will increase the comfort of its use and
      increase the compliance of patients to the prescribed compression regime after intervention;
      2) it is assumed that the lack of compression in the foot area will not lead to the
      development of its swelling and a decrease in the comfort of wearing compression hosiery.
    

Intervention name(s): Short stocking; Usual stocking
Intervention type(s): Device; Device
Intervention description(s): Patients in the experimental group will be asked to wear new type of compression stockings for four weeks post-operatively; Patients in the control group will be asked to wear usual type of compression 2 class stockings for four weeks post-operatively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: compression stocking; elastic stocking; endovenous radiofrequency ablation; compression therapy