OBJECTIVE: To clarify the benefit of energy devices such as ultrasonically activated device and bipolar vessel sealing device in liver surgeries. BACKGROUND: Several studies have suggested the benefit of energy devices in liver transection, while a randomized trial has found no association between their use and surgical outcomes. PATIENTS AND METHODS: Patients scheduled to undergo open liver resection were eligible for this multicenter non-blinded randomized study. They were randomized to receive an energy device (experimental group) or not (control group) during liver transection. The primary endpoint was the proportion of patients with intraoperative blood loss >1,000 mL. The primary aim was to show non-inferiority of hepatectomy with energy device to that without energy device. RESULTS: A total of 212 patients were randomized and 211 (105 and 106 in the respective groups) were analyzed. Intraoperative blood loss >1,000 mL occurred in 15.0% patients with energy device and 20.2% patients without energy device. The experimental minus control group difference was -5.2% (95% confidence interval -13.8 to 3.3%; non-inferiority test, p = 0.0248). Hepatectomy with energy device resulted in a shorter median liver transection time (63 vs. 84 min; p < 0.001) and a lower rate of postoperative bile leakage (4 vs. 16%; p = 0.002). CONCLUSIONS: The hypothesis that hepatectomy with energy device is not inferior to that without energy device in terms of blood loss has been demonstrated. The use of energy devices during liver surgery is clinically meaningful as it shortens the liver transection time and reduces the incidence of postoperative bile leakage.
RCT Entities:
OBJECTIVE: To clarify the benefit of energy devices such as ultrasonically activated device and bipolar vessel sealing device in liver surgeries. BACKGROUND: Several studies have suggested the benefit of energy devices in liver transection, while a randomized trial has found no association between their use and surgical outcomes. PATIENTS AND METHODS: Patients scheduled to undergo open liver resection were eligible for this multicenter non-blinded randomized study. They were randomized to receive an energy device (experimental group) or not (control group) during liver transection. The primary endpoint was the proportion of patients with intraoperative blood loss >1,000 mL. The primary aim was to show non-inferiority of hepatectomy with energy device to that without energy device. RESULTS: A total of 212 patients were randomized and 211 (105 and 106 in the respective groups) were analyzed. Intraoperative blood loss >1,000 mL occurred in 15.0% patients with energy device and 20.2% patients without energy device. The experimental minus control group difference was -5.2% (95% confidence interval -13.8 to 3.3%; non-inferiority test, p = 0.0248). Hepatectomy with energy device resulted in a shorter median liver transection time (63 vs. 84 min; p < 0.001) and a lower rate of postoperative bile leakage (4 vs. 16%; p = 0.002). CONCLUSIONS: The hypothesis that hepatectomy with energy device is not inferior to that without energy device in terms of blood loss has been demonstrated. The use of energy devices during liver surgery is clinically meaningful as it shortens the liver transection time and reduces the incidence of postoperative bile leakage.
Authors: Nuh N Rahbari; Moritz Koch; Thomas Schmidt; Edith Motschall; Thomas Bruckner; Kathrin Weidmann; Arianeb Mehrabi; Markus W Büchler; Jürgen Weitz Journal: Ann Surg Oncol Date: 2009-01-07 Impact factor: 5.344