OBJECTIVE: Thermoablation has been replacing conventional surgery in the surgical treatment of great saphenous vein (GSV) reflux in patients with lower limb varicose veins; however, thermoablation is expensive. Intravenous electrocoagulation (EC) may, selectively and safely, cause necrosis of the GSV wall, but the clinical results have never been studied. The objective of this study was to compare EC and radiofrequency ablation (RFA) in the treatment of GSV insufficiency, considering efficacy, complications, and effect on quality of life. METHODS: This was a prospective, double-blind, randomized clinical trial. Patients with lower limb varicose veins and GSV reflux confirmed by duplex ultrasound were randomized into two treatment groups: EC and RFA. Patients were followed up at 1 week, 3 months, and 6 months after the procedure. Occlusion of the GSV confirmed by duplex ultrasound was considered the primary outcome, and the rate of complications and improvement in quality of life, using the Aberdeen Varicose Vein Questionnaire score, were the secondary outcomes. RESULTS:Fifty-seven patients were included, with a total of 85 treated GSVs; 43 were treated with RFA and 42 with EC. There was no statistically significant difference between the groups regarding age (P = .264), sex (P = .612), Aberdeen Varicose Vein Questionnaire score (P = .054), and diameter (P = .880) and depth (P = .763) of the treated GSV. In the intraoperative period, immediately after thermoablation, all GSVs treated with EC presented no flow and incompressibility in the treated segment, whereas 12 limbs still had flow in the treated GSV (P < .001) and 9 veins showed compressibility (P < .001) when treated with RFA. The main postoperative complication was paresthesia; however, there was no statistical significance between the groups (P = .320) regarding its presence. Time to return to routine activities was lower in the EC group than in the RFA group (P = .026). There was no difference between the groups at the 3-month (P = .157) and 6-month (P = .157) follow-up in occlusion of the GSV and improvement of the quality of life score (P = .786 and P = .401, respectively). CONCLUSIONS:EC has been shown to be an effective method for ablation of the GSV, with venous occlusion rate, occurrence of complications, and effect on quality of life similar to those with RFA.
RCT Entities:
OBJECTIVE: Thermoablation has been replacing conventional surgery in the surgical treatment of great saphenous vein (GSV) reflux in patients with lower limb varicose veins; however, thermoablation is expensive. Intravenous electrocoagulation (EC) may, selectively and safely, cause necrosis of the GSV wall, but the clinical results have never been studied. The objective of this study was to compare EC and radiofrequency ablation (RFA) in the treatment of GSV insufficiency, considering efficacy, complications, and effect on quality of life. METHODS: This was a prospective, double-blind, randomized clinical trial. Patients with lower limb varicose veins and GSV reflux confirmed by duplex ultrasound were randomized into two treatment groups: EC and RFA. Patients were followed up at 1 week, 3 months, and 6 months after the procedure. Occlusion of the GSV confirmed by duplex ultrasound was considered the primary outcome, and the rate of complications and improvement in quality of life, using the Aberdeen Varicose Vein Questionnaire score, were the secondary outcomes. RESULTS: Fifty-seven patients were included, with a total of 85 treated GSVs; 43 were treated with RFA and 42 with EC. There was no statistically significant difference between the groups regarding age (P = .264), sex (P = .612), Aberdeen Varicose Vein Questionnaire score (P = .054), and diameter (P = .880) and depth (P = .763) of the treated GSV. In the intraoperative period, immediately after thermoablation, all GSVs treated with EC presented no flow and incompressibility in the treated segment, whereas 12 limbs still had flow in the treated GSV (P < .001) and 9 veins showed compressibility (P < .001) when treated with RFA. The main postoperative complication was paresthesia; however, there was no statistical significance between the groups (P = .320) regarding its presence. Time to return to routine activities was lower in the EC group than in the RFA group (P = .026). There was no difference between the groups at the 3-month (P = .157) and 6-month (P = .157) follow-up in occlusion of the GSV and improvement of the quality of life score (P = .786 and P = .401, respectively). CONCLUSIONS: EC has been shown to be an effective method for ablation of the GSV, with venous occlusion rate, occurrence of complications, and effect on quality of life similar to those with RFA.