Impact of Energy Devices During Liver Parenchymal Transection: A Multicenter Randomized Controlled Trial

医学 肝切除术 随机对照试验 置信区间 外科 临床终点 心脏外科 腹部外科 失血 心胸外科 麻醉 切除术 内科学
作者
Naoto Gotohda,Takeharu Yamanaka,Akio Saiura,Katsuhiko Uesaka,Masaji Hashimoto,Masaru Konishi,Kazuaki Shimada
出处
期刊:World Journal of Surgery [Springer Science+Business Media]
卷期号:39 (6): 1543-1549 被引量:41
标识
DOI:10.1007/s00268-015-2967-y
摘要

Abstract 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.
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