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Completed

NCT Number: NCT06913764

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moscow City Hospital named after A.K. Eramishantsev

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

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

Device

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

Primary outcomes

  1. Level of postoperative pain at 14 days

    Time frame: 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).

Secondary outcomes

  1. Area (centimeter square) of ecchymosis

    Time frame: 14 days

    Assessed by an expert by measuring ecchymoses using a specialized smartphone application "LesionMeter".

  2. Number of patients with clinical manifestations of phlebitis at 14 days

    Time frame: 14 days

    Clinical significant appearance of signs of inflammation (hyperemia, swelling, pain) of the superficial veins

  3. The change of clinical class of chronic venous disease according to the CEAP classification in the operated lower limb at 28 days

    Time frame: 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.

  4. VCSS score at 14 days

    Time frame: 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.

  5. VCSS score at 28 days

    Time frame: 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.

  6. The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 14 days

    Time frame: 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.

  7. The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 28 days

    Time frame: 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.

  8. CIVIQ-20 score at 14 days

    Time frame: 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.

  9. CIVIQ-20 score at 28 days

    Time frame: 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.

  10. Compliance with the use of Medical Compression Stockings (MCS)

    Time frame: 14 days

    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).

  11. Comfort with the use of MCS at 14 days

    Time frame: 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).

  12. Comfort with the use of MCS at 28 days

    Time frame: 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).

  13. Difficulty in putting on a compression stocking at 14 days

    Time frame: 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).

  14. Difficulty in putting on a compression stocking at 28 days

    Time frame: 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).

  15. The circumference length of the narrowest part of the calf above the ankle one month after the intervention at 28 days

    Time frame: 28 days

    The circumference length of the narrowest part of the calf was measured by an expert using a measuring tape.

Sponsors and collaborators

Lead sponsor

Moscow City Hospital named after A.K. Eramishantsev

Other Gov

Collaborators

  • Pirogov Russian National Research Medical University
  • Vishnevsky Center of Surgery

Registry information

Official study title

First- or Second- Class Compression Hosiery After Endovenous Laser With Sclerotherapy and Ambulatory Phlebectomy: Randomized Controlled Trial (FISCHER)

Acronym: FISCHER

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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