A prospective trial evaluating the clinical performance of a novel surgical energy device in laparoscopic colon surgery
A prospective trial evaluating the clinical performance of a novel surgical energy device in laparoscopic colon surgery
复制标题
DOI：
10.1007/s00464-014-3783-4
复制
发表时间：
2015-05-01
影响因子：
3.1
通讯作者：
Lee, S.
中科院分区：
文献类型：
--
作者：
Milsom, J. W.;Trencheva, K.;Lee, S.
本前瞻性人体试验旨在评价新型THUNDERBEAT（TB）能量器械在腹腔镜结肠手术中的临床性能。本研究报告了在美国首次使用该联合能量器械进行结肠手术的人体试验，这是一项前瞻性初探性研究，在一家机构中有30名受试者接受了左侧或右侧腹腔镜结肠切除术治疗肿瘤。使用TB进行所有软组织剥离和所有血管结扎。未在腹腔内使用其他能量器械。记录的终点为解剖时间（从结肠动员开始到标本取出）、手术时间、从腹腔取出TB的次数、术中并发症（肠系膜剥离或血管结扎时出血、术中热损伤、其他器官损伤）、技术器械问题、术后并发症30名受试者（15名男性）入组研究，中位年龄和范围为68.5（21-86），BMI kg/m2为25.5（20-35）。12例受试者接受了右侧和18例左侧腹腔镜半结肠切除术。平均手术时间为163 +/- A 86 min，使用TB器械剥离的平均手术时间为80.6 +/- A 35 min。所有受试者的大血管结扎均成功。闭合肠系膜下动脉的TB应用次数中位数为3（2-8）。在解剖过程中将TB从腹腔中取出，以进行头端清洁，中等次数为2次/例。无术中或术后并发症（出血、热损伤等）TB装置在左和右结肠切除术中的组织剥离和血管结扎中表现出有效和成功的性能。TB技术可用于复杂的腹部手术，并可通过更快的解剖节省时间，但需要与其他能量器械进行比较研究来证实这一点。
The aim of this prospective human trial was to evaluate the clinical performance of a novel THUNDERBEAT (TB) energy device in laparoscopic colon surgery. This study reports the first human trial in USA with this combined energy device in colon surgery.This is a prospective pilot study with 30 subjects undergoing left or right laparoscopic colon resection for neoplasm in a single institution. All soft tissue dissections and all vessel ligations were performed using TB. No other energy device was used within the abdomen. Recorded end-points were dissection time (from the start of colon mobilization to specimen removal), surgical procedure time, the number of times TB taken out of the abdominal cavity, intraoperative complications (bleeding at the time of mesenteric dissection or vessel ligation, thermal injury during surgery, injury of other organs), technical device problems, postoperative complications (bleeding, delayed thermal injuries, other complications within 30 days), length of hospital stay, and mortality.Thirty subjects (15 males) were enrolled in the study with median age and range 68.5 (21-86) and BMI kg/m(2) 25.5 (20-35). Twelve subjects underwent right and 18 left laparoscopic hemicolectomy. The mean surgical procedure time was 163 +/- A 86 min and for dissection using TB device 80.6 +/- A 35 min. Major vessel ligation was successful in all subjects. The median number of TB applications to seal inferior mesenteric artery was 3 (2-8). TB was taken out of the abdominal cavity during dissection for tip cleaning a medium number of two times/per case. No intraoperative or postoperative complications (bleeding, thermal injuries, etc.) related to use of TB were noted.The TB device demonstrated efficient and successful performance at tissue dissection and vessel ligation in left and right colectomies. TB technology can be employed in complex abdominal surgery and may save time through faster dissection but comparative studies with other energy devices are needed to confirm this.