Treatment of Varicose Veins by Injection of Foam guided by Ultrasound

Not Applicable

• Conditions: I83.9; Venous Insufficiency, Varicose Veins, Obesity; I87.2

• Registration Number: RBR-67d69p
• Lead Sponsor: Hospital Universitário da Universidade Federal de Sergipe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Aged between 18 and 60 years inclusive. Male and female sex. Informed consent authorization. Reflux diagnosed by Doppler ultrasound in any saphenous vein extension and / or trunk varicose veins measuring between 4 and 8mm in diameter inclusive. Varicose veins classified APEC 3,4,5 and 6. Body mass index (BMI) between 25 and 40kg/m2.

Exclusion Criteria

Patient with psychiatric disorder or limitation in the technique compreendimento. Women during pregnancy or risk pregnancy (without effective contraception) or nursing. Patients with a personal history of deep vein thrombosis and / or PET. Patients with known allergy to Polidocanol (synonyms: Lauromacrogol 400, macrogollauryleter, PEG9lauryl-alcohol). Patients with severe or chronic decompensated (hepatic insufficiency, renal insufficiency, CHF, COPD, respiratory insufficiency, progressive, malignant disease, hypertension and / or diabetes mellitus uncompensated). Intra-atrial or ventricular septal defect diagnosed by echocardiography. Closing of / attend the scheduled follow-ups. Patients who have Peripheral Arterial Disease Installed (ankle-brachial index less than 0, 9)

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The expected primary outcome will be complete luminal occlusion of the vessel underwent embolization with polidocanol and use or non-use of elastic stockings for long periods. The method used to check the expected outcome will be the vascular echo doppler in 3 weeks, 3 months and 6 months after the procedure. The parameter that will be used to check the outcome actually occurred will be the absence of detectable speed through the vascular echo Doppler that show what actually occurred thrombosis within the vessel.<br>

Secondary Outcome Measures

Name	Time	Method
The expected secondary outcome will be the presence of local and / or systemic complications of treatment. The method used to check the expected outcome will be the vascular clinical examination carried out in 3 weeks, 3 months and 6 months after the procedure. The parameter used to verify that the outcome actually occurred will be the presence of areas of dermal necrosis, tomboflebite symptomatic deep vein thrombosis, visual disturbances, chest pain, allergic reaction and death.