Clinical trial NCT03477227: New Compression Hosiery Versus Standard Class II Compression Stockings After Endothermal Ablation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Vascular Diseases
Keywords: compression stocking
elastic stocking
endovenous radiofrequency ablation
compression therapy
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
Collaborators: name: Medalp Private Surgery Clinic
name: Research Clinical Centre of the Russian Railways, JSC
First posted: 2018-03-26
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life score measured by CIVIQ20 questionnaire
timeFrame: 30 days
Secondary outcomes:
measure: Pain level
timeFrame: 1, 7, 14, 21, 30 days
measure: Comfort of using compression hosiery
timeFrame: 1, 7, 14, 21, 30 days
Other outcomes:
measure: Foot swelling
timeFrame: 1, 7, 14, 21, 30 days
Locations:
city: Moscow
country: Russian Federation
facility: The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
city: Saint Petersburg
country: Russian Federation
facility: Road Clinical Hospital of JSC "Russian Railways"
city: Saint Petersburg
country: Russian Federation
facility: Medalp Private Surgery Clinic
Study officials:
affiliation: The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov
name: Igor Zolotukhin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.