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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 187
- Locations
- 6
- Primary Endpoint
- Quality of life score measured by CIVIQ20 questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Quality of life score measured by CIVIQ20 questionnaire
Time Frame: 30 days
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.
Secondary Outcomes
- Comfort of using compression hosiery(1, 7, 14, 21, 30 days)
- Pain level(1, 7, 14, 21, 30 days)
Investigators
Igor Zolotukhin
Clinical Professor
Pirogov Russian National Research Medical University