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

San Donato Group (GSD)

Status: Enrolling

Conditions: Vascular Surgical Procedures

Treatments: Device: Elastic-compressive stockings

Study type: Interventional

Funder types: Other

Identifiers

NCT05766579

41/int/2019

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients (>18 years) suffering from varicose vein pathology of the lower limbs C2-3 class (varicose veins, edema) according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification, supported by incontinence of the great saphenous vein documented by Echo-Duplex study and candidates for thermal ablation by radiofrequency of the great vein saphenous vein with associated phlebectomy of the ipsilateral thigh and/or leg varices.

Exclusion criteria

• Patients who are minors (< 18 years old) or adults who have not given their consent to participate in the study.
• Presence of severe obliterating arterial disease of the lower limbs (ABI <0.5)
• Obesity (BMI >30)
• Varicose pathology of the lower limbs in C4-C6 class according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification (presence of:

lipodermatosclerosis/eczema and/or ulcers in progress and/or previous ulcers in the affected lower limb).

• Pregnancy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

K1, 18-21 mmHg

Experimental group

Description:

Use of elastic stockings at 18-21 mmHg after endovenous thermal ablation

Treatment:

Device: Elastic-compressive stockings

K2, 23-32 mmHg

Experimental group

Description:

Use of elastic stockings at 23-32 mmHg after endovenous thermal ablation

Treatment:

Device: Elastic-compressive stockings