Toomey Paul G, Ross Sharona B, Choung Edward, Donn Natalie, Vice Michelle, Luberice Kenneth, Albrink Michael, Rosemurgy Alexander S
Florida Hospital Tampa, Tampa, Florida.
JSLS. 2015 Apr-Jun;19(2). doi: 10.4293/JSLS.2015.00007.
As technology in surgery evolves, the medical instrument industry is inevitability involved in promoting the use and appropriate (ie, effective and safe) application of its products. This study was undertaken to evaluate industry-supported product safety courses in laparoendoscopic single-site (LESS) surgery, by using the metrics of surgeons' adoption of the technique, safety of the procedure, and surgeons' perception of the surgery.
LESS surgery courses that involved didactic lectures, operative videos, operation observation, collaborative learning, and simulation, were attended by 226 surgeons. With Florida Hospital Tampa Institutional Review Board approval, the surgeons were queried before and immediately after the course, to assess their attitudes toward LESS surgery. Then, well after the course, the surgeons were contacted, repeatedly if necessary, to complete questionnaires.
Before the course, 82% of the surgeons undertook more than 10 laparoscopic operations per month. Immediately after the course, 86% were confident that they were prepared to perform LESS surgery. Months after the course, 77% of the respondents had adopted LESS surgery, primarily cholecystectomy; 59% had added 1 or more trocars in 0-20% of their procedures; and 73% held the opinion that operating room observation was the most helpful learning experience. Complications with LESS surgery were noted 12% of the time. Advantages of the technique were better cosmesis (58%) and patient satisfaction (38%). Disadvantages included risk of complications (37%) and higher technical demand (25%). Seventy-eight percent viewed LESS surgery as an advancement in surgical technique.
In multifaceted product safety courses, operating room observation is thought to provide the most helpful instruction for those wanting to undertake LESS surgery. The procedure has been safely adopted by surgeons who frequently perform laparoscopies. The tradeoff is in performing a more difficult technique to obtain better cosmesis for the patient. We must continue to conduct critical evaluations of product safety courses for the introduction of new technology in surgery.
随着外科手术技术的发展，医疗器械行业不可避免地参与到推广其产品的使用及合理（即有效且安全）应用之中。本研究旨在通过外科医生对该技术的采用情况、手术安全性以及外科医生对该手术的认知等指标，评估行业支持的腹腔镜单孔手术（LESS）产品安全课程。
226名外科医生参加了包含理论讲座、手术视频、手术观摩、协作学习及模拟的LESS手术课程。经佛罗里达坦帕医院机构审查委员会批准，在课程开始前及结束后即刻对外科医生进行询问，以评估他们对LESS手术的态度。然后，在课程结束很久之后，如有必要则多次联系外科医生以完成问卷调查。
课程开始前，82%的外科医生每月进行超过10例腹腔镜手术。课程结束后即刻，86%的医生有信心准备好开展LESS手术。课程结束数月后，77%的受访者采用了LESS手术，主要是胆囊切除术；59%的医生在0 - 20%的手术中增加了1个或更多穿刺孔；73%的医生认为手术室观摩是最有帮助的学习体验。LESS手术并发症发生率为12%。该技术的优点是美容效果更好（58%）和患者满意度更高（38%）。缺点包括并发症风险（37%）和技术要求更高（25%）。78%的人认为LESS手术是外科技术的一项进步。
在多方面的产品安全课程中，手术室观摩被认为对想要开展LESS手术的人提供了最有帮助的指导。经常进行腹腔镜手术的外科医生已安全采用该手术。权衡在于要实施一项更具难度的技术以给患者带来更好的美容效果。我们必须继续对用于外科手术新技术引入的产品安全课程进行严格评估。
