Clinical trial NCT06913764: First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy
Official title: First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy: Randomized Controlled Trial (FISCHER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Varicose Veins
Chronic Venous Disorder
Chronic Venous Insufficiency (CVI)
Venous Reflux
Great Saphenous Vein (GSV) With Venous Reflux Disease
Keywords: Varicose veins
Varicose disease
Compression therapy
medical compression stockings
MCS
venous disease
veins
vein surgery
elastic hosiery
compression hosiery
endovenous laser
endovenous laser ablation
thermal ablation
sclerotherapy
microsclerotherapy
phlebectomy
ambulatory phlebectomy
elastic compression
Lead sponsor: Moscow City Hospital named after A.K. Eramishantsev
Sponsor class: OTHER_GOV
Collaborators: name: Pirogov Russian National Research Medical University
name: Vishnevsky Center of Surgery
First posted: 2025-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, open, non-inferiority randomized controlled trial with a blinded outcome assessor
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Varicose veins of the lower extremities (CEAP classification C2-C5)
* Varicose disease in the great saphenous vein (GSV) and its tributaries
* Planned endovenous laser ablation of the GSV trunk with concomitant combined sclerotherapy and phlebectomy of tributaries
* Technical success of intervention (complete ablation of the GSV)
* Signed informed consent for study participation

Exclusion Criteria:

* Primary reflux outside the GSV trunk
* History of or acute deep vein thrombosis
* Deep vein insufficiency
* GSV recanalization post-intervention
* Clinical class C6 of chronic venous disease (CVD) according to CEAP classification
* Contraindications or limitations for prolonged compression therapy, including but not limited to chronic arterial diseases of the lower extremities (any severity), skin diseases
* Pathological conditions of lower limbs causing non-venous pain
* Use of vasoactive medications within 1 month before/after surgery
* Refusal to participate in the study

Primary outcomes:
measure: Level of postoperative pain at 14 days
timeFrame: 14 days
Secondary outcomes:
measure: Area (centimeter square) of ecchymosis
timeFrame: 14 days
measure: Number of patients with clinical manifestations of phlebitis at 14 days
timeFrame: 14 days
measure: The change of clinical class of chronic venous disease according to the CEAP classification in the operated lower limb at 28 days
timeFrame: 28 days
measure: VCSS score at 14 days
timeFrame: 14 days
measure: VCSS score at 28 days
timeFrame: 28 days
measure: The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 14 days
timeFrame: 14 days
measure: The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 28 days
timeFrame: 28 days
measure: CIVIQ-20 score at 14 days
timeFrame: 14 days
measure: CIVIQ-20 score at 28 days
timeFrame: 28 days
measure: Compliance with the use of Medical Compression Stockings (MCS)
timeFrame: 14 days
measure: Comfort with the use of MCS at 14 days
timeFrame: 14 days
measure: Comfort with the use of MCS at 28 days
timeFrame: 28 days
measure: Difficulty in putting on a compression stocking at 14 days
timeFrame: 14 days
measure: Difficulty in putting on a compression stocking at 28 days
timeFrame: 28 days
measure: The circumference length of the narrowest part of the calf above the ankle one month after the intervention at 28 days
timeFrame: 28 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow City Hospital named after A.K. Eramishantsev
Study officials:
affiliation: Moscow City Hospital named after A.K. Eramishantsev
name: Hovsep P. Manjikian, MD
role: STUDY_CHAIR
affiliation: Moscow City Hospital named after A.K. Eramishantsev
name: Boris Danelian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moscow City Hospital named after A.K. Eramishantsev
name: Hovsep Manjikyan, MD
role: PRINCIPAL_INVESTIGATOR
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