OBJECTIVE: The aim of this randomized study was to compare a new method of endovenous saphenous vein obliteration (Closure System, VNUS Medical Technologies, Inc, Sunnyvale, Calif) with the conventional stripping operation in terms of short-term recovery and costs. METHODS: Twenty-eight selected patients for operative treatment of primary greater saphenous veintributary varicose veins were randomly assigned to endovenous obliteration (n = 15) or stripping operation (n = 13). Postoperative pain was daily assessed during the 1st week and on the 14th postoperative day. The length of sick leave was determined. The RAND-36 health survey was used to assess the patient health-related quality of life. The patient conditions were controlled 7 to 8 weeks after surgery, and patients underwent examination with duplex ultrasonography. The comparison of costs included both direct medical costs and costs resulting from lost of productivity of the patients. Costs that were similar in the study groups were not considered in the analysis. RESULTS: All operations were successful, and the complication rates were similar in the two groups. Postoperative average pain was significantly less severe in the endovenous obliteration group as compared with the stripping group (at rest: 0.7, standard deviation [SD] 0.5, versus 1.7, SD 1.3, P =.017; on standing: 1.3, SD 0.7, versus 2.6, SD 1.9, P =.026; on walking: 1.8, SD 0.8, versus 3.0, SD 1.8, P =.036; with t test). The sick leaves were significantly shorter in the endovenous obliteration group (6.5 days, SD 3.3 days, versus 15.6 days, SD 6.0 days; 95% CI, 5.4 to 12.9; P <.001, with t test). Physical function was also restored faster in the endovenous obliteration group. The estimated annual investment costs of the closure operation were US $3360. The other direct medical costs of the Closure operation were about $850, and those of the conventional treatment were $360. With inclusion of the value of the lost working days, the Closure treatment was cost-saving for society, and when 40% of the patients are retired (or 60% of the productivity loss was included), the Closure procedure became cost-saving at a level of 43 operations per year. CONCLUSION:Endovenous obliteration may offer advantages over the conventional stripping operation in terms of reduced postoperative pain, shorter sick leaves, and faster return to normal activities, and it appears to be cost-saving for society, especially among employed patients. Because the procedure is also associated with shorter convalescence, this new method may potentially replace conventional varicose vein surgery.
RCT Entities:
OBJECTIVE: The aim of this randomized study was to compare a new method of endovenous saphenous vein obliteration (Closure System, VNUS Medical Technologies, Inc, Sunnyvale, Calif) with the conventional stripping operation in terms of short-term recovery and costs. METHODS: Twenty-eight selected patients for operative treatment of primary greater saphenous vein tributary varicose veins were randomly assigned to endovenous obliteration (n = 15) or stripping operation (n = 13). Postoperative pain was daily assessed during the 1st week and on the 14th postoperative day. The length of sick leave was determined. The RAND-36 health survey was used to assess the patient health-related quality of life. The patient conditions were controlled 7 to 8 weeks after surgery, and patients underwent examination with duplex ultrasonography. The comparison of costs included both direct medical costs and costs resulting from lost of productivity of the patients. Costs that were similar in the study groups were not considered in the analysis. RESULTS: All operations were successful, and the complication rates were similar in the two groups. Postoperative average pain was significantly less severe in the endovenous obliteration group as compared with the stripping group (at rest: 0.7, standard deviation [SD] 0.5, versus 1.7, SD 1.3, P =.017; on standing: 1.3, SD 0.7, versus 2.6, SD 1.9, P =.026; on walking: 1.8, SD 0.8, versus 3.0, SD 1.8, P =.036; with t test). The sick leaves were significantly shorter in the endovenous obliteration group (6.5 days, SD 3.3 days, versus 15.6 days, SD 6.0 days; 95% CI, 5.4 to 12.9; P <.001, with t test). Physical function was also restored faster in the endovenous obliteration group. The estimated annual investment costs of the closure operation were US $3360. The other direct medical costs of the Closure operation were about $850, and those of the conventional treatment were $360. With inclusion of the value of the lost working days, the Closure treatment was cost-saving for society, and when 40% of the patients are retired (or 60% of the productivity loss was included), the Closure procedure became cost-saving at a level of 43 operations per year. CONCLUSION: Endovenous obliteration may offer advantages over the conventional stripping operation in terms of reduced postoperative pain, shorter sick leaves, and faster return to normal activities, and it appears to be cost-saving for society, especially among employed patients. Because the procedure is also associated with shorter convalescence, this new method may potentially replace conventional varicose vein surgery.