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IRCT20180223038837N1 IRCT 2018-12-08 Kermanshah University of Medical Sciences Comparative study of radiofrequency ablation & foam sclerotherapy for treatment patients suffering from varicose veins Comparative study of radiofrequency ablation & foam sclerothrapy for treatment patients suffering from great saphenous varicose vein 2018-10-23 anticipated 60 Complete https://irct.ir/trial/32039 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 60 patients with entering criteria were selected by available sampling. Then, randomly using a random number table, they are placed in one of two groups of foam sclerotherapy and RFA. N/A Varicose veins of lower extremities. Intervention 1: Interventional Group 1: This group treated with radiofrequency ablation .Treatment includes segmental thermal ablation of great saphenous vein through a catheter by seven-centimeters element . thermal ablation started two centemeters of below the saphenofemoral junction. In each segment, temperature remains at about 120 degree centegrades for 20 seconds. In this project used radiofrequency catheter for Covidian brand, made in Costa Rica, to do ablation. Intervention 2: Intervention group 2(Foam sclerotherapy): This group will be treated with Foam sclerotherapy . Foam includes fibrovein with air with a ratio of one- fifth (with Tesari Method) is mixed and injected into the vein Under ultrasound guidance. It continues as long as the foam reaches of two centimeter of saphenofemoral junction and causes ablation in the vein Endothelium by chemical inflammation. In this project, Sclerosing substance of fibrovein brand, made in England , is used for foam sclerotherapy. Yes - There is a plan to make this available What will be shared: In the case of the participant's data file, three months after the publication of the article, and after unidentification of the persons, the request can be sent by email. When: Three months after the publication of the article, upon request, by email, there is a possibility to post. To whom: Only scholars working in academic and scientific institutions Conditions: The name of the first author of the study is required in an extracted article from the study data. In this case, it is possible to perform any statistical analysis. Where to obtain: Correspondence by e-mail with the Doctor Mohammadreza Sobhiyeh. Email: mreza.sobhiyeh@yahoo.com How to obtain: Up to one week after receipt of the email, the requested documentation is sent. Comments:
public Mohammad Reza Sobhiyeh
Imam Reza Hospital., Parastar Blvd.
Kermanshah Iran (Islamic Republic of) 671441533 +98 83 3427 6333 mreza.sobhiyeh@yahoo.com Kermanshah University of Medical Sciences scientific Mohammad Reza Sobhiyeh
Imam reza hospital-parastar Ave-kermanshah
Kermanshah Iran (Islamic Republic of) 671441533 +98 83 3427 6333 mreza.sobhiyeh@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Conscious patient consent to enter the study The patient suffers from great saphenous varicose vein No history of varicose vein The diameter of the great saphenous vein at 3 cm below the saphenophemoral junction in Doppler sonography is between 10 to 20 mm. No duplication of varicose vein Non-use of anti-coagulans and antiplatelet drugs No history of vascular insufficiency 18 years 75 years Both Failure to collaborate for follow-up I83 Varicose veins of lower extremities Treatment - Devices Treatment - Devices Interventional Group 1: This group treated with radiofrequency ablation .Treatment includes segmental thermal ablation of great saphenous vein through a catheter by seven-centimeters element . thermal ablation started two centemeters of below the saphenofemoral junction. In each segment, temperature remains at about 120 degree centegrades for 20 seconds. In this project used radiofrequency catheter for Covidian brand, made in Costa Rica, to do ablation. Intervention group 2(Foam sclerotherapy): This group will be treated with Foam sclerotherapy . Foam includes fibrovein with air with a ratio of one- fifth (with Tesari Method) is mixed and injected into the vein Under ultrasound guidance. It continues as long as the foam reaches of two centimeter of saphenofemoral junction and causes ablation in the vein Endothelium by chemical inflammation. In this project, Sclerosing substance of fibrovein brand, made in England , is used for foam sclerotherapy. Recurrence of Varicose Veins. Timepoint: One week, one month, three months, six months and 12 months after treatment. Method of measurement: Color Doppler Ultrasonography. Quality of life. Timepoint: Before and a week after treatment. Method of measurement: SF-36 questionnaire. Intensity of pain. Timepoint: Before and a week after treatment. Method of measurement: Visual Analoge Scale. Condition of Varicose veins. Timepoint: Before and a week after treatment. Method of measurement: Aberdeen Varicose Veins Questionnaire. The interval between the treatment process and the return to usual life. Timepoint: after treatment. Method of measurement: The patient is asked. The cost of treatment. Timepoint: After treatment. Method of measurement: Documentation file. Kermanshah University of Medical Sciences Approved 2018-09-23 Ethics Committee of Kermanshah University of Medical Sciences Imam Reza Hospital, Parastar Blvd Kermanshah Kermanshah Iran (Islamic Republic of)