New Compression Hosiery Versus Standard Class II Compression Stockings After Endothermal Ablation (COSMOS)

Comparison of a Short Compression Hosiery (Stocking Without a Foot) With Standard Compression Stockings After Radiofrequency Ablation of Great Saphenous Vein With Phlebectomy: a Multicenter Randomized Controlled Non-inferiority Trial

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.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Varicose Veins
• Intervention / Treatment: Device: Short stocking; Device: Usual stocking

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.

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 117997
    • The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
  • Saint Petersburg, Russian Federation, 195271
    • Road Clinical Hospital of JSC "Russian Railways"
  • Saint Petersburg, Russian Federation, 197758
    • Medalp Private Surgery Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults over 18 years of age
• Symptomatic great saphenous vein (GSV) vein reflux > 0.5 seconds on color Duplex
• CEAP C2-C4 (inclusive)
• Informed consent

Exclusion Criteria:

• Symptomatic small saphenous vein (SSV) vein reflux
• CEAP Class C5 or C6 disease
• Prior GSV treatment
• History of deep vein thrombosis
• Acute deep or superficial vein thrombosis
• Pregnancy
• Patients who are unable to attend the hospital for follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short stocking; After radiofrequency ablation of the GSF and phlebectomy varicose tributaries, patients will wear compression socks without foot for four weeks	Device: Short stocking; Patients in the experimental group will be asked to wear new type of compression stockings for four weeks post-operatively
Active Comparator: Usual stocking; After radiofrequency ablation of the GSF and phlebectomy varicose tributaries, patients will wear usual compression socks for four weeks (usual care)	Device: Usual stocking; Patients in the control group will be asked to wear usual type of compression 2 class stockings for four weeks post-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score measured by CIVIQ20 questionnaire	The specific quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) score Calculation of the Global Index Score (GIS) of CIVIQ-20 There are 20 questions in the CIVIQ-20, each with 5 possible answers (1 to 5), the minimum possible score being 20 and the maximum 100. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (100-20=80), multiplied by 100.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Patient's post-procedure pain score using a visual analogue scale (VAS) Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).	1, 7, 14, 21, 30 days
Comfort of using compression hosiery	Comfort of using compression hosiery on a visual analogue scale (VAS) Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "comfort" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the comfort VAS have been recommended: comfort (0-4 mm), mild comfort (5-44 mm), moderate comfort (45-74 mm), and no comfort (75-100 mm).	1, 7, 14, 21, 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot swelling	Circumference of the foot	1, 7, 14, 21, 30 days

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University
• Collaborators: Medalp Private Surgery Clinic; Research Clinical Centre of the Russian Railways, JSC
• Investigators: Principal Investigator: Igor Zolotukhin, The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov

Publications and helpful links

General Publications

• Zolotukhin I, Demekhova M, Ilyukhin E, Sonkin I, Zakharova E, Efremova O, Kiseleva E, Gavrilov E. A randomized trial of class II compression sleeves for full legs versus stockings after thermal ablation with phlebectomy. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1235-1240. doi: 10.1016/j.jvsv.2020.12.067. Epub 2021 Apr 20.

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2017
• Primary Completion (Actual): December 29, 2018
• Study Completion (Actual): December 29, 2018

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: compression therapy; compression stocking; elastic stocking; endovenous radiofrequency ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: COSMOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data collection will take place at the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). Register in Russian. Registry now listed in the database ClinicalTrials.gov, ID NCT03035747 (see references)
• IPD Sharing Time Frame: Access to the data will be available after completion of the study.
• IPD Sharing Access Criteria: To access the data will need to send a request to RRT CVD administrator.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No