Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of fist class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.
In recent decades, significant advancements have emerged in varicose vein treatment. Endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) have become the leading techniques for eliminating trunk reflux, while microfoam sclerotherapy and ambulatory phlebectomy are most commonly used for treating tributaries. Post-intervention, patients typically receive recommendations to wear second-class compression stockings to reduce postoperative pain, ecchymosis, and hematomas. However, the optimal duration, regimen, and compression class remain poorly defined. Meanwhile, a growing surgical community advocates for eliminating compression therapy during the postoperative period altogether, citing low patient compliance rates (15-74%). The primary factors driving non-compliance include discomfort while wearing hosiery and difficulties with donning and doffing, suggesting compression hosiery characteristics may significantly impact adherence. Recent meta-analyses support compression therapy's benefits, demonstrating reduced postoperative pain levels and faster return to normal activities among patients using postoperative compression. Additionally, both national and international clinical guidelines recommend compression therapy for at least one week following thermal ablations. Investigators hypothesize that first class compression therapy during the postoperative period will improve patient adherence due to easier application and reduced discomfort. Therefore, planning to compare the effectiveness of first class versus second class compression therapy two weeks after EVLA of the great saphenous vein with concomitant combined sclerotherapy and ambulatory phlebectomy of tributaries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
100
Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) above-knee graduated compression stockings
Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings
Moscow City Hospital named after A.K. Eramishantsev
Moscow, Russia
Level of postoperative pain at 14 days
The intensity of postoperative pain is subjectively assessed by the patient on a 10-centimeter numeric scale daily. The range is from 0 (no pain) to 10 (pain of maximal intensity).
Time frame: 14 days
Area (centimeter square) of ecchymosis
Assessed by an expert by measuring ecchymoses using a specialized smartphone application "LesionMeter".
Time frame: 14 days
Number of patients with clinical manifestations of phlebitis at 14 days
Clinical significant appearance of signs of inflammation (hyperemia, swelling, pain) of the superficial veins
Time frame: 14 days
The change of clinical class of chronic venous disease according to the CEAP classification in the operated lower limb at 28 days
The class of chronic venous disease in the operated lower limb is assessed by an expert during a clinical examination based on the CEAP classification.
Time frame: 28 days
VCSS score at 14 days
The severity of chronic venous disease (CVD) in the target lower limb is assessed during clinical examination using the updated Venous Clinical Severity Score (VCSS). Ranges from 0 to 30. The maximal score indicates more severe CVD.
Time frame: 14 days
VCSS score at 28 days
The severity of chronic venous disease (CVD) in the target lower limb is assessed during clinical examination using the updated Venous Clinical Severity Score (VCSS). Ranges from 0 to 30. The maximal score indicates more severe CVD.
Time frame: 28 days
The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 14 days
Venous-specific symptoms are assessed by the patient independently using a numerical rating scale. The range is from 0 to 100, with a minimum score indicating the best quality of life.
Time frame: 14 days
The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 28 days
Venous-specific symptoms are assessed by the patient independently using a numerical rating scale. The range is from 0 to 100, with a minimum score indicating the best quality of life.
Time frame: 28 days
CIVIQ-20 score at 14 days
The quality of life is assessed by the patient independently according to the vein-specific questionnaire Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20). range 0-100, a minimal score indicates the best quality of life.
Time frame: 14 days
CIVIQ-20 score at 28 days
The quality of life is assessed by the patient independently according to the vein-specific questionnaire Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20). range 0-100, a minimal score indicates the best quality of life.
Time frame: 28 days
Compliance with the use of Medical Compression Stockings (MCS)
Compliance with the use of MCS is assessed based on the study of the patient's diaries in Groups 1 and 2 as a proportion of the number of days when the patient used MCS for at least 8 hours to the total duration of prescribed compression (14 days), represented as a percentage (n\[MCS\]/14\*100%). It ranges from 0% (no compliance) to 100% (absolute compliance).
Time frame: 14 days
Comfort with the use of MCS at 14 days
The patients subjectively assess their comfort when using MCS using a 100-cm numeric rating scale, which ranges from 0 (no comfort) to 10 (absolute comfort).
Time frame: 14 days
Comfort with the use of MCS at 28 days
The patients subjectively assess their comfort when using MCS using a 100-cm numeric rating scale, which ranges from 0 (no comfort) to 10 (absolute comfort).
Time frame: 28 days
Difficulty in putting on a compression stocking at 14 days
Patients subjectively assess the level of difficulty in putting on the compression stockings using a 100-point numerical scale, which ranges from 0 (no difficulty) to 100 (absolute difficulty).
Time frame: 14 days
Difficulty in putting on a compression stocking at 28 days
Patients subjectively assess the level of difficulty in putting on the compression stockings using a 100-point numerical scale, which ranges from 0 (no difficulty) to 100 (absolute difficulty).
Time frame: 28 days
The circumference length of the narrowest part of the calf above the ankle one month after the intervention at 28 days
The circumference length of the narrowest part of the calf was measured by an expert using a measuring tape.
Time frame: 28 days
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