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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06913764

Acronym

FISCHER

Enrollment

100

Registered

2025-04-06

Start date

2025-04-07

Completion date

2025-07-02

Last updated

2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

Interventions

DEVICEclass 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

DEVICEclass 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Masking description

A single-center, open, non-inferiority randomized controlled trial with a blinded outcome assessor.

Intervention model description

A single-center, open, non-inferiority randomized controlled trial with a blinded outcome assessor

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Level of postoperative pain at 14 days	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

Measure	Time frame	Description
Number of patients with clinical manifestations of phlebitis at 14 days	14 days	Clinical significant appearance of signs of inflammation (hyperemia, swelling, pain) of the superficial veins
The change of clinical class of chronic venous disease according to the CEAP classification in the operated lower limb at 28 days	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.
VCSS score at 14 days	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.
VCSS score at 28 days	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.
The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 14 days	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.
The intensity of primary venous-specific symptoms on the operated lower limb according to a numerical rating scale at 28 days	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.
CIVIQ-20 score at 14 days	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.
Area (centimeter square) of ecchymosis	14 days	Assessed by an expert by measuring ecchymoses using a specialized smartphone application LesionMeter.
Compliance with the use of Medical Compression Stockings (MCS)	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).
Comfort with the use of MCS at 14 days	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).
Comfort with the use of MCS at 28 days	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).
Difficulty in putting on a compression stocking at 14 days	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).
Difficulty in putting on a compression stocking at 28 days	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).
The circumference length of the narrowest part of the calf above the ankle one month after the intervention at 28 days	28 days	The circumference length of the narrowest part of the calf was measured by an expert using a measuring tape.
CIVIQ-20 score at 28 days	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.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026