A prospective trial evaluating the clinical performance of a novel surgical energy device in laparoscopic colon surgery
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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.
Methods and procedures
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/m2 25.5 (20–35). Twelve subjects underwent right and 18 left laparoscopic hemicolectomy. The mean surgical procedure time was 163 ± 86 min and for dissection using TB device 80.6 ± 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.
KeywordsCombined energy device Laparoscopy Colectomy THUNDERBEAT
The Authors wish to acknowledge and express sincere gratitude to Olympus for the financial support of this project. Further, the author would like to thank Malinka Velcheva for her help in the data collection for this study and to thank our medical illustrator Yuko Tonohira for preparing the images in this manuscript.
This particular study was investigator initiated and was funded by research grant from Olympus. Each author has the following disclosures: Dr. Jeffrey W. Milsom received Advanced Technology Master Course support and research support from Olympus. Drs. Toyooki Sonoda, Govind. Nandakumar, MD, Parul. J. Shukla, MD and Sang Lee, MD received course support from Olympus. Koiana Trencheva, MS has no conflicts of interest or financial ties to disclose.
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