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

Last updated: April 7, 2025
Sponsor: Moscow City Hospital named after A.K. Eramishantsev
Overall Status: Active - Recruiting

Phase

N/A

Condition

Varicose Veins

Heartburn (Pediatric)

Occlusions

Treatment

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

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

Clinical Study ID

NCT06913764
1/2025
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 combinedsclerotherapy and phlebectomy of tributaries

  • Technical success of intervention (complete ablation of the GSV)

  • Signed informed consent for study participation

Exclusion

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 butnot 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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: class I compression stockings of the RAL-GZ 387 standard: 1 month using
Phase:
Study Start date:
April 07, 2025
Estimated Completion Date:
July 01, 2025

Study 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.

Connect with a study center

  • Moscow City Hospital named after A.K. Eramishantsev

    Moscow,
    Russian Federation

    Active - Recruiting

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