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

July 2, 2025 updated by: Moscow City Hospital named after A.K. Eramishantsev

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Moscow City Hospital named after A.K. Eramishantsev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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
Active Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area (centimeter square) of ecchymosis
Time Frame: 14 days
Assessed by an expert by measuring ecchymoses using a specialized smartphone application "LesionMeter".
14 days
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
14 days
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.
28 days
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.
14 days
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.
28 days
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.
14 days
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.
28 days
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.
14 days
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.
28 days
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).
14 days
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).
14 days
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).
28 days
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 days
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).
28 days
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow City Hospital named after A.K. Eramishantsev

Collaborators

Pirogov Russian National Research Medical University
Vishnevsky Center of Surgery

Investigators

  • Study Chair: Hovsep P. Manjikian, MD, Moscow City Hospital named after A.K. Eramishantsev
  • Principal Investigator: Boris Danelian, MD, Moscow City Hospital named after A.K. Eramishantsev
  • Principal Investigator: Hovsep Manjikyan, MD, Moscow City Hospital named after A.K. Eramishantsev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

July 2, 2025

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Local regulations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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