PDF(Pubmed)
Abstract：
The THUNDERBEAT is a multi-functional energy device which delivers both ultrasonic and bipolar energy, but there are no randomized trials which can provide more rigorous evaluation of the clinical performance of THUNDERBEAT compared to other energy-based devices in colorectal surgery. The aim of this study was to compare the clinical performance of THUNDERBEAT energy device to Maryland LigaSure in patients undergoing left laparoscopic colectomy.
Prospective randomized trial with two groups: Group 1 THUNDERBEAT and Group 2 LigaSure in a single university hospital. 60 Subjects, male and female, of age 18 years and above undergoing left colectomy for cancer or diverticulitis were included. The primary outcome was dissection time to specimen removal (DTSR) measured in minutes from the start of colon mobilization to specimen removal from the abdominal cavity. Versatility (composite of five variables) was measured by a score system from 1 to 5 (1 being worst and 5 the best), and adjusted/weighted by coefficient of importance with distribution of the importance as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue manipulation 0.1. Other variables were: dryness of surgical field, intraoperative and postoperative complications, and mortality. Follow-up time was 30 days.
60 Patients completed surgery, 31 in Group 1 and 29 in Group 2. There was no difference in the DTSR between the groups, 91 min vs. 77 min (p = 0.214). THUNDERBEAT showed significantly higher score in dissecting and tissue manipulation in segment 3 (omental dissection), and in overall versatility score (p = 0.007) as well as versatility score in Segment 2 (retroperitoneal dissection p = 0.040) and Segment 3 (p = 0.040). No other differences were noted between the groups.
Both energy devices can be employed effectively and safely in dividing soft tissue and sealing mesenteric blood vessels during laparoscopic left colon surgery, with THUNDERBEAT demonstrating some advantages over LigaSure during omental dissection and tissue manipulation.
gov # NCT02628093.
Prospective randomized trial with two groups: Group 1 THUNDERBEAT and Group 2 LigaSure in a single university hospital. 60 Subjects, male and female, of age 18 years and above undergoing left colectomy for cancer or diverticulitis were included. The primary outcome was dissection time to specimen removal (DTSR) measured in minutes from the start of colon mobilization to specimen removal from the abdominal cavity. Versatility (composite of five variables) was measured by a score system from 1 to 5 (1 being worst and 5 the best), and adjusted/weighted by coefficient of importance with distribution of the importance as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue manipulation 0.1. Other variables were: dryness of surgical field, intraoperative and postoperative complications, and mortality. Follow-up time was 30 days.
60 Patients completed surgery, 31 in Group 1 and 29 in Group 2. There was no difference in the DTSR between the groups, 91 min vs. 77 min (p = 0.214). THUNDERBEAT showed significantly higher score in dissecting and tissue manipulation in segment 3 (omental dissection), and in overall versatility score (p = 0.007) as well as versatility score in Segment 2 (retroperitoneal dissection p = 0.040) and Segment 3 (p = 0.040). No other differences were noted between the groups.
Both energy devices can be employed effectively and safely in dividing soft tissue and sealing mesenteric blood vessels during laparoscopic left colon surgery, with THUNDERBEAT demonstrating some advantages over LigaSure during omental dissection and tissue manipulation.
gov # NCT02628093.
摘要：
Thunderbeat是一种多功能的能量装置，提供超声波和双极能量，但与其他基于能量的装置在结直肠手术中相比,没有随机试验能够对THUNDERBEAT的临床表现提供更严格的评估.这项研究的目的是比较THUNDERBEAT能量装置与MarylandLigaSure在接受左腹腔镜结肠切除术的患者中的临床性能。
在一所大学医院进行前瞻性随机试验，分为两组：第1组THUNDERBEAT和第2组LigaSure。60名受试者,男性和女性，18岁及以上的患者因癌症或憩室炎接受左结肠切除术。主要结果是从结肠动员开始到从腹腔取出标本的解剖时间（DTSR），以分钟为单位。多功能性（五个变量的综合）通过1到5的评分系统来衡量（1是最差的，5是最好的），并通过重要性系数调整/加权，重要性分布如下：止血0.275，密封0.275，切割0.2，解剖0.15和组织操作0.1。其他变量是：手术区域的干燥，术中和术后并发症，和死亡率。随访时间为30天。
60名患者完成了手术，第1组中为31，第2组中为29。两组之间的DTSR没有差异，91分钟vs.77分钟（p=0.214）。THUNDERBEAT在第3段（网膜解剖）的解剖和组织操作中显示出明显更高的分数，总体多功能性评分（p=0.007）以及第2段（腹膜后夹层p=0.040）和第3段（p=0.040）的多功能性评分。两组之间没有其他差异。
在腹腔镜左结肠手术期间，两种能量装置均可有效且安全地用于分割软组织和封闭肠系膜血管，Thunderbeat在网膜解剖和组织操作中显示出比LigaSure的一些优势。
gov#NCT02628093。
在一所大学医院进行前瞻性随机试验，分为两组：第1组THUNDERBEAT和第2组LigaSure。60名受试者,男性和女性，18岁及以上的患者因癌症或憩室炎接受左结肠切除术。主要结果是从结肠动员开始到从腹腔取出标本的解剖时间（DTSR），以分钟为单位。多功能性（五个变量的综合）通过1到5的评分系统来衡量（1是最差的，5是最好的），并通过重要性系数调整/加权，重要性分布如下：止血0.275，密封0.275，切割0.2，解剖0.15和组织操作0.1。其他变量是：手术区域的干燥，术中和术后并发症，和死亡率。随访时间为30天。
60名患者完成了手术，第1组中为31，第2组中为29。两组之间的DTSR没有差异，91分钟vs.77分钟（p=0.214）。THUNDERBEAT在第3段（网膜解剖）的解剖和组织操作中显示出明显更高的分数，总体多功能性评分（p=0.007）以及第2段（腹膜后夹层p=0.040）和第3段（p=0.040）的多功能性评分。两组之间没有其他差异。
在腹腔镜左结肠手术期间，两种能量装置均可有效且安全地用于分割软组织和封闭肠系膜血管，Thunderbeat在网膜解剖和组织操作中显示出比LigaSure的一些优势。
gov#NCT02628093。
