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一种空间定位设备在自然腔道内镜手术中应用的前瞻性、随机评估。

A prospective, randomized assessment of a spatial orientation device in natural orifice transluminal endoscopic surgery.

机构信息

Gastrointestinal Diseases Research Unit, Queen’s University, Kingston, Ontario, Canada.

出版信息

Gastrointest Endosc. 2011 Jan;73(1):123-7. doi: 10.1016/j.gie.2010.09.013.

DOI:10.1016/j.gie.2010.09.013
PMID:21184877
Abstract

BACKGROUND

One of the challenges in natural orifice transluminal endoscopic surgery (NOTES) is spatial orientation. The Queen's NOTES group has devised a novel method of orientation by using a magnetic device that passes within an endoscope channel allowing for 3-dimensional imaging of the shape and orientation of the endoscope.

OBJECTIVE

To assess the feasibility and utility of a novel orientation device.

DESIGN

Randomized, controlled trial.

SETTING

Animal research laboratory study on four 25-kg pigs.

INTERVENTION

The device was tested by 6 endoscopists and 6 laparoscopic surgeons. Starting at the gastrotomy, the time to identify 4 targets was recorded. Participants were required to identify and touch the gallbladder, the fallopian tube, a clip on the abdominal wall, and the liver edge. Use of the orientation device was randomized for each session.

MAIN OUTCOME MEASUREMENTS

Time to identify targets with and without the device. Secondary analysis assessed differences between medical specialties and level of training.

RESULTS

The mean time to identify all 4 targets with the device was 75.08 ± 42.68 seconds versus 100.20 ± 60.70 seconds without the device (P <.001). The mean time to identify all 4 targets on the first attempt was 102.29 ± 61.36 seconds versus 72.99 ± 40.19 seconds on the second attempt (P <.001). No differences based on specialty or level of training were identified.

LIMITATIONS

Small sample size and simplicity of tasks.

CONCLUSION

Regardless of randomization order, both groups were faster with the device. These encouraging results warrant further study using more complex scenarios.

摘要

背景

自然腔道内镜外科(NOTES)的挑战之一是空间定位。皇后NOTES 小组设计了一种新颖的定位方法,使用一种可在内窥镜通道内通过的磁性装置,实现了内窥镜形状和方向的三维成像。

目的

评估新型定位装置的可行性和实用性。

设计

随机对照试验。

设置

在 4 只 25 公斤重的猪的动物研究实验室进行。

干预措施

该装置由 6 名内镜医生和 6 名腹腔镜外科医生进行测试。从胃造口术开始,记录识别 4 个目标的时间。参与者需要识别并触摸胆囊、输卵管、腹壁上的夹子和肝缘。每次试验随机使用定位装置。

主要观察测量指标

使用和不使用装置识别目标的时间。次要分析评估了医学专业和培训水平之间的差异。

结果

使用装置识别所有 4 个目标的平均时间为 75.08 ± 42.68 秒,而不使用装置的平均时间为 100.20 ± 60.70 秒(P <.001)。首次尝试识别所有 4 个目标的平均时间为 102.29 ± 61.36 秒,而第二次尝试的平均时间为 72.99 ± 40.19 秒(P <.001)。未根据专业或培训水平确定差异。

局限性

样本量小且任务简单。

结论

无论随机分组顺序如何,两组使用装置时都更快。这些令人鼓舞的结果证明有必要使用更复杂的场景进一步研究。

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引用本文的文献

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Natural orifice transluminal endoscopic surgery: new minimally invasive surgery come of age.自然腔道内镜手术:新的微创外科时代的到来。
World J Gastroenterol. 2011 Oct 21;17(39):4382-8. doi: 10.3748/wjg.v17.i39.4382.