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Study aim
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The aim of this study was to compare the clinical results and complications of two new methods of varicose vein treatment
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Design
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Two arm parallel group single-blind randomized trial, on 1090 patients. The rand function of Excel software (random table) is used for randomization.
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Settings and conduct
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All patients referred to the Varice Clinic located in Tehran, Iran undergo Doppler ultrasound and if they have inclusion criteria and no exclusion criteria, they will be included in the study. Patients are divided into two groups based on a random number table. In the first group, laser treatment is performed and in the second method, radiofrequency method is performed. Because all preoperative procedures are the same for patients and only the device used in the operating room is different, the patient is not informed of the method used and becomes blind.
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Participants/Inclusion and exclusion criteria
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All patients aged 18-65 years referred to the Varice Clinic who consider color Doppler ultrasound of saphenous vein insufficiency and reflux of sapheno-femoral junction and are candidates for endovenous treatment are included in the study.
Recurrent cases, impossible to follow-up patients, pregnant women, people with active cancer, lower extremity arterial disease, active DVT, thrombophilia, people at high risk for pulmonary embolism and a history of inguinal surgery other than hernias are excluded.
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Intervention groups
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In the first group, patients are treated with endovenous laser for ablation of varicose veins after transfer to the operating room and local anesthesia, and in the second group, this treatment is using a radio frequency (RF) ablation device.
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Main outcome variables
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Duration of surgery; Intraoperative and postoperative pain; Pain in the third week, third, sixth and twelfth months; Complications of surgery; Recurrence of varicose veins, CEAP stage , AVVSS score