OBJECTIVE: The aim of this trial was to verify the new surgical device (the LigaSure vessels sealing system) decrease liver transection time. SUMMARY BACKGROUND DATA: Among the major goals in hepatic resection are minimization of the operation time and of the blood loss. Preliminary reports have suggested that the vessel sealing system might decrease the liver transection time, which is directly associated with the amount of blood loss. METHODS:Patients who were scheduled to undergo hepatic resection at the Tokyo University Hospital were assigned, by the minimization method, to either use of the new vessel sealing system (VS group) or the conventional clamp crushing method (CC group) for liver transection. The primary end point was the liver transection time, and the secondary endpoints were the amount of blood loss during the entire operation and during liver transection, length of hospital stay, postoperative liver function, and the incidence of various adverse events. An English-language summary of the protocol was submitted (registration ID: C000000337) to the Clinical Trials Registry managed by the University Hospital Medical Information Network in Japan, which can be accessed commission-free on the internet (Available at: http://www.umin.ac.jp/ctr/index.htm). RESULTS:From February to December in 2006, a total of 165 patients underwent liver resection for some benign or malignant disease of the liver. Among these patients, 120 were randomly assigned to the CC (n = 60) or the VS (n = 60) group. There was no mortality in either of the 2 groups. The median liver transection time in the VS group was 57 minutes (range: 11-127), similar to that in the CC group (56 [range: 9-269] min, P = 0.64), while there was no difference in the transection speed between the 2 groups (1.16 [0.15-2.26] cm/min vs. 1.10 [0.15-2.66] cm/min, P = 0.95). The amount of blood loss and blood loss per transection area during liver transaction in the VS group was also similar to that in the CC group (median: 315 [25-2415] mLvs. 315 [10-1700] mL; P = 0.80) and (5.04 [1.01-44.2] mL/cm vs. 4.36 [0.15-50.5] mL/cm; P = 0.14), respectively. CONCLUSIONS: This randomized controlled trial showed that while the vessel sealing system was safe, its use was not associated with any significant decrease of the operation time or blood loss during liver transaction as compared with that of the clamp crushing method.
RCT Entities:
OBJECTIVE: The aim of this trial was to verify the new surgical device (the LigaSure vessels sealing system) decrease liver transection time. SUMMARY BACKGROUND DATA: Among the major goals in hepatic resection are minimization of the operation time and of the blood loss. Preliminary reports have suggested that the vessel sealing system might decrease the liver transection time, which is directly associated with the amount of blood loss. METHODS:Patients who were scheduled to undergo hepatic resection at the Tokyo University Hospital were assigned, by the minimization method, to either use of the new vessel sealing system (VS group) or the conventional clamp crushing method (CC group) for liver transection. The primary end point was the liver transection time, and the secondary endpoints were the amount of blood loss during the entire operation and during liver transection, length of hospital stay, postoperative liver function, and the incidence of various adverse events. An English-language summary of the protocol was submitted (registration ID: C000000337) to the Clinical Trials Registry managed by the University Hospital Medical Information Network in Japan, which can be accessed commission-free on the internet (Available at: http://www.umin.ac.jp/ctr/index.htm). RESULTS: From February to December in 2006, a total of 165 patients underwent liver resection for some benign or malignant disease of the liver. Among these patients, 120 were randomly assigned to the CC (n = 60) or the VS (n = 60) group. There was no mortality in either of the 2 groups. The median liver transection time in the VS group was 57 minutes (range: 11-127), similar to that in the CC group (56 [range: 9-269] min, P = 0.64), while there was no difference in the transection speed between the 2 groups (1.16 [0.15-2.26] cm/min vs. 1.10 [0.15-2.66] cm/min, P = 0.95). The amount of blood loss and blood loss per transection area during liver transaction in the VS group was also similar to that in the CC group (median: 315 [25-2415] mL vs. 315 [10-1700] mL; P = 0.80) and (5.04 [1.01-44.2] mL/cm vs. 4.36 [0.15-50.5] mL/cm; P = 0.14), respectively. CONCLUSIONS: This randomized controlled trial showed that while the vessel sealing system was safe, its use was not associated with any significant decrease of the operation time or blood loss during liver transaction as compared with that of the clamp crushing method.