New Compression Hosiery Versus Standard Class II Compression Stockings After Endothermal Ablation

Vascular Diseases Clinical Trial

— COSMOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477227
• Other study ID #: COSMOS
• Status: Completed
• Phase: N/A
• Start date: December 29, 2017
• Est. completion date: December 29, 2018

Study information

• Verified date: April 2020
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: December 29, 2018
• Est. primary completion date: December 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins
• Vascular Diseases

Intervention

Device:
• Short stocking
Patients in the experimental group will be asked to wear new type of compression stockings for four weeks post-operatively
• Usual stocking
Patients in the control group will be asked to wear usual type of compression 2 class stockings for four weeks post-operatively

Locations

Country	Name	City	State
Russian Federation	The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation	Moscow
Russian Federation	Medalp Private Surgery Clinic	Saint Petersburg
Russian Federation	Road Clinical Hospital of JSC "Russian Railways"	Saint Petersburg

Sponsors (3)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University	Medalp Private Surgery Clinic, Research Clinical Centre of the Russian Railways, JSC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Foot swelling	Circumference of the foot	1, 7, 14, 21, 30 days
Primary	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	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
Secondary	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