KeyLoop retractor for global gasless laparoscopy: evaluation of safety and feasibility in a porcine model.

KeyLoop retractor for global gasless laparoscopy: evaluation of safety and feasibility in a porcine model.
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全球无气腹腔镜的Keyloop牵开器:猪模型中安全性和可行性的评估。

DOI:
10.1007/s00464-023-10054-5
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发表时间:
2023-08
期刊:
Surgical endoscopy
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低收入和中等收入国家的许多外科医生描述了由于无法获得二氧化碳和可靠的电力而使用无气(提升)腹腔镜进行手术,但该技术的安全性和可行性尚未得到很好的记录。我们描述了KeyLoop的体内安全性和实用性的临床前测试,KeyLoop是一种腹腔镜牵开器系统,可实现无气体腹腔镜手术。经验丰富的腹腔镜外科医生在猪模型中完成了一系列四项腹腔镜任务:腹腔镜暴露、小肠切除、打结的结肠内引流和胆囊切除术。对于每名参与的外科医生,使用KeyLoop在一只练习动物中完成四项任务。然后,外科医生使用标准护理(SOC)气体腹腔镜和KeyLoop以区组随机顺序完成这些任务,以最大限度地减少学习曲线效应。使用配对非参数检验比较SOC和KeyLoop之间的生命体征、任务完成时间、失血量和手术并发症。外科医生完成了一项关于使用KeyLoop与气体腹腔镜的调查。由设盲的病理学家评价腹壁组织的损伤。5名外科医生在15头猪身上完成了60项任务。KeyLoop和SOC之间完成任务的时间没有显著差异。对于所有任务,存在与学习猪模型相关的任务完成时间的学习曲线。KeyLoop和SOC之间在失血量、生命体征或手术并发症方面没有显著差异。来自美国和新加坡的11名外科医生认为KeyLoop可以安全地用于进行几种常见的外科手术。KeyLoop或SOC均未观察到腹壁组织损伤。对于基本外科手术,KeyLoop和SOC气体腹腔镜的手术时间、失血量、腹壁组织损伤和手术并发症相似。这些数据支持KeyLoop作为一种有用的工具,以增加低收入和中等收入国家的腹腔镜手术。在线版本包含补充材料,可通过10.1007/s 00464 -023-10054-5获得。
Many surgeons in low- and middle-income countries have described performing surgery using gasless (lift) laparoscopy due to inaccessibility of carbon dioxide and reliable electricity, but the safety and feasibility of the technique has not been well documented. We describe preclinical testing of the in vivo safety and utility of KeyLoop, a laparoscopic retractor system to enable gasless laparoscopy. Experienced laparoscopic surgeons completed a series of four laparoscopic tasks in a porcine model: laparoscopic exposure, small bowel resection, intracorporeal suturing with knot tying, and cholecystectomy. For each participating surgeon, the four tasks were completed in a practice animal using KeyLoop. Surgeons then completed these tasks using standard-of-care (SOC) gas laparoscopy and KeyLoop in block randomized order to minimize learning curve effect. Vital signs, task completion time, blood loss and surgical complications were compared between SOC and KeyLoop using paired nonparametric tests. Surgeons completed a survey on use of KeyLoop compared to gas laparoscopy. Abdominal wall tissue was evaluated for injury by a blinded pathologist. Five surgeons performed 60 tasks in 15 pigs. There were no significant differences in times to complete the tasks between KeyLoop and SOC. For all tasks, there was a learning curve with task completion times related to learning the porcine model. There were no significant differences in blood loss, vital signs or surgical complications between KeyLoop and SOC. Eleven surgeons from the United States and Singapore felt that KeyLoop could be used to safely perform several common surgical procedures. No abdominal wall tissue injury was observed for either KeyLoop or SOC. Procedure times, blood loss, abdominal wall tissue injury and surgical complications were similar between KeyLoop and SOC gas laparoscopy for basic surgical procedures. This data supports KeyLoop as a useful tool to increase access to laparoscopy in low- and middle-income countries. The online version contains supplementary material available at 10.1007/s00464-023-10054-5.
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