OBJECTIVE: To compare the long-term value of different forms of treatment for primary varicose veins with saphenous vein insufficiency. EXPERIMENTAL DESIGN: A prospective, partially randomized study with 5-year follow-up. SETTING: Ambulatory day-case care. PATIENTS AND INTERVENTIONS: The study includes 211 patients (214 lower limbs), who receivedcompression sclerotherapy (CST; n = 78), radical operation (OP; n = 74) orCST combined with high tie under local anesthesia (HT + CST; n = 63). MEASURES: The patient's subjective opinion, objective finding by the surgeon and functional (foot-volumetric) assessment were obtained just after treatment and 6 months, 1, 3 and 5 years later. RESULTS: Subjectively the result started to deteriorate in both the CST and HT + CST groups after one year. The patient satisfaction was greatest in the OP group throughout the study period. Objectively the CST group cure rate fell markedly after 6 months and at 5 year follow-up the failure rate reached 51%, while the OP group still had a high rate of cured (60%) and improved (35%) patients. The HT + CST treatment seemed to hold well for three years followed by increasing failure rate with only 16% objectively cured after 5 years. The foot-volumetric parameters expelled volume (= calf pump function) and refilling flow ratio (= venous reflux) increased 51-79% respectively decreased 8-29% post-treatment in all groups. After 5 years these parameters had returned to pre-treatment levels in the CST and HT + CST groups, while the OP group was still significantly improved. CONCLUSIONS:Radical surgery is superior to compression sclerotherapy alone or in combination with high tie in the treatment of varicose veins with saphenous vein incompetence. The foot-volumetric assessment correlated well with and supported objective findings as a whole but could not replace the clinical examination of each individual patient.
RCT Entities:
OBJECTIVE: To compare the long-term value of different forms of treatment for primary varicose veins with saphenous vein insufficiency. EXPERIMENTAL DESIGN: A prospective, partially randomized study with 5-year follow-up. SETTING: Ambulatory day-case care. PATIENTS AND INTERVENTIONS: The study includes 211 patients (214 lower limbs), who received compression sclerotherapy (CST; n = 78), radical operation (OP; n = 74) or CST combined with high tie under local anesthesia (HT + CST; n = 63). MEASURES: The patient's subjective opinion, objective finding by the surgeon and functional (foot-volumetric) assessment were obtained just after treatment and 6 months, 1, 3 and 5 years later. RESULTS: Subjectively the result started to deteriorate in both the CST and HT + CST groups after one year. The patient satisfaction was greatest in the OP group throughout the study period. Objectively the CST group cure rate fell markedly after 6 months and at 5 year follow-up the failure rate reached 51%, while the OP group still had a high rate of cured (60%) and improved (35%) patients. The HT + CST treatment seemed to hold well for three years followed by increasing failure rate with only 16% objectively cured after 5 years. The foot-volumetric parameters expelled volume (= calf pump function) and refilling flow ratio (= venous reflux) increased 51-79% respectively decreased 8-29% post-treatment in all groups. After 5 years these parameters had returned to pre-treatment levels in the CST and HT + CST groups, while the OP group was still significantly improved. CONCLUSIONS: Radical surgery is superior to compression sclerotherapy alone or in combination with high tie in the treatment of varicose veins with saphenous vein incompetence. The foot-volumetric assessment correlated well with and supported objective findings as a whole but could not replace the clinical examination of each individual patient.