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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vascular Surgical Procedures

Intervention / Treatment
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* Device: Elastic-compressive stockings


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K1, 18-21 mmHg<br>Use of elastic stockings at 18-21 mmHg after endovenous thermal ablation | Device: Elastic-compressive stockings<br>* Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.<br>|
| Experimental: K2, 23-32 mmHg<br>Use of elastic stockings at 23-32 mmHg after endovenous thermal ablation | Device: Elastic-compressive stockings<br>* Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale) | 3 days after surgery | 
| Postoperative Pain | Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale) | 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower limb edema | Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter | 3 days from intervention | 
| Lower limb edema | Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter | 7 days from intervention | 
| Lower limb edema | Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter | 30 days from intervention | 
| Analgesic Drugs Use | Evaluation of the possible use of analgesic drugs for postoperative pain. | 3 days from intervention | 
| Analgesic Drugs Use | Evaluation of the possible use of analgesic drugs for postoperative pain. | 7 days from intervention | 
| Analgesic Drugs Use | Evaluation of the possible use of analgesic drugs for postoperative pain. | 30 days from intervention | 
| Discomfort | Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire . | 3 days from intervention | 
| Discomfort | Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire . | 7 days from intervention | 
| Discomfort | Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire . | 30 days from intervention | 
| Postoperative Complications | Evaluation of the incidence of postoperative complications | 3 days from intervention | 
| Postoperative Complications | Evaluation of the incidence of postoperative complications | 7 days from intervention | 
| Postoperative Complications | Evaluation of the incidence of postoperative complications | 30 days from intervention | 
| Evaluation of Quality of Life | Evaluation of the quality of life using a questionnaire | 3 days from intervention | 
| Evaluation of Quality of Life | Evaluation of the quality of life using a questionnaire | 7 from intervention | 
| Evaluation of Quality of Life | Evaluation of the quality of life using a questionnaire. | 30 days from intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stockings, Compression, Thermoablation, Radiofrequency, Saphenous Vein