First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy

NCT ID: NCT06913764

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2025-07-02

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.

Conditions

Varicose Veins; Chronic Venous Disorder; Chronic Venous Insufficiency (CVI); Venous Reflux; Great Saphenous Vein (GSV) With Venous Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Class 1 (18-21 mm Hg at the ankle level) above-knee graduated compression stockings

All participants will undergo measurement of the affected limb at standard points to select the appropriate size of compression stockings. Then, the clinical class of chronic venous disease will be assessed for the study participants according to the CEAP classification, the severity of chronic venous disease will be evaluated using the VCSS scale, quality of life will be measured using the CIVIQ-20 questionnaire, and the intensity of venous-specific symptoms will be assessed using a numerical rating scale. After the surgical intervention, a class 1 compression stocking will be put on, which they will wear continuously for 24 hours; thereafter, it must be worn during the daytime for 28 days. Upon discharge, patients will receive a diary in which they will record postoperative pain and the fact of wearing the compression garment each day for 14 days. Follow-up visits will be scheduled for 14 days and 28 days after the surgical intervention.

Group Type: EXPERIMENTAL

class I compression stockings of the RAL-GZ 387 standard: 1 month using

Intervention Type: DEVICE

Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) above-knee graduated compression stockings

Class 2 (23-32 mm Hg at the ankle level) above-knee graduated compression stockings

All participants will undergo measurement of the affected limb at standard points to select the appropriate size of compression stockings. Then, the clinical class of chronic venous disease will be assessed for the study participants according to the CEAP classification, the severity of chronic venous disease will be evaluated using the VCSS scale, quality of life will be measured using the CIVIQ-20 questionnaire, and the intensity of venous-specific symptoms will be assessed using a numerical rating scale. After the surgical intervention, a class 2 compression stocking will be put on, which they will wear continuously for 24 hours; thereafter, it must be worn during the daytime for 28 days. Upon discharge, patients will receive a diary in which they will record postoperative pain and the fact of wearing the compression garment each day for 14 days. Follow-up visits will be scheduled for 14 days and 28 days after the surgical intervention.

Group Type: ACTIVE_COMPARATOR

class II compression stockings of the RAL-GZ 387 standard: 1 month using

Intervention Type: DEVICE

Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings

Interventions

class I compression stockings of the RAL-GZ 387 standard: 1 month using

Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) above-knee graduated compression stockings

Intervention Type: DEVICE

class II compression stockings of the RAL-GZ 387 standard: 1 month using

Class 2 (RAL-GZ 387 standard: 23-32 mm Hg at the ankle level) above-knee graduated compression stockings

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pirogov Russian National Research Medical University

OTHER

Sponsor Role: collaborator

Vishnevsky Center of Surgery

OTHER

Sponsor Role: collaborator

Moscow City Hospital named after A.K. Eramishantsev

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hovsep P. Manjikian, MD

Role: STUDY_CHAIR

Moscow City Hospital named after A.K. Eramishantsev

Boris Danelian, MD

Role: PRINCIPAL_INVESTIGATOR

Moscow City Hospital named after A.K. Eramishantsev

Hovsep Manjikyan, MD

Role: PRINCIPAL_INVESTIGATOR

Moscow City Hospital named after A.K. Eramishantsev

Locations

Moscow City Hospital named after A.K. Eramishantsev

Moscow, , Russia

Countries

Russia

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Related Links

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Other Identifiers

1/2025

Identifier Type: -

Identifier Source: org_study_id