RecruitingNot ApplicableNCT05766579

Comparison Trial Between Elastic-compressive Stockings at 21 Versus 32 mmHg

ElaStic-compressive Stockings at 21 mmHg and 32 mmHg Following Thermal Ablation of the Great Saphenous Vein.

Sponsor

IRCCS Policlinico S. Donato

Enrollment

64 participants

Start Date

Apr 2, 2019

Study Type

INTERVENTIONAL

Conditions

Vascular Surgical Procedures

Summary

Endovascular thermal ablation is currently considered as the best procedure for treating varicose veins thanks to its mini-invasiveness and the lowest rate of incidence of complications. At the end of the endovascular ablation procedure, the European Society of Vascular Surgery (ESVS) guidelines recommend the use of the compression stockings to reduce postoperative pain and the incidence of edema and thrombotic complications. Despite this, the duration, type and degree of compression to be used, particularly after radiofrequency ablation procedures, remain a matter of debate. Furthermore, although the benefits of postoperative elastic compression therapy are well known, there is various evidence demonstrating how patients often experience poor comfort in wearing stockings, especially those with a higher degree of compression, which causes poor compliance with therapy. In light of all this, each center recommends the use of elastic compression stockings in the postoperative period with a degree of compression that varies, however, according to internal protocols. There is currently no work in the literature that compares the advantages and disadvantages of using elastic compression stockings with a K2 versus K1 compression degree after radiofrequency ablative surgery.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two different compression stocking pressures — 21 mmHg versus 32 mmHg — for preventing complications and promoting recovery after radiofrequency ablation treatment for varicose veins. Compression stockings are routinely prescribed after varicose vein procedures to reduce swelling, bruising, and the risk of blood clots, but the optimal compression level is debated, with different guidelines recommending different pressures. Adults over 18 with varicose veins of the leg (CEAP class C2-3 — meaning visible varicose veins with some swelling) due to a leaky great saphenous vein who are scheduled for radiofrequency ablation and phlebectomy (surgical removal of visible varicose veins) are eligible. Patients who are minors, have severe arterial disease of the leg, obesity (BMI >30), severe varicose disease with skin damage or ulcers (CEAP C4-C6), or are pregnant are excluded. Varicose veins affect up to 30% of adults and are a major source of discomfort, cosmetic concern, and healthcare utilization. Knowing the right compression level after treatment could reduce complications, improve outcomes, and simplify post-procedure care. This pragmatic trial will provide clear guidance on a common clinical decision that currently varies widely between practitioners.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEElastic-compressive stockings

Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.

Locations(1)

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Milan, Italy

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NCT05766579

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