A Trial of Segmental Stiffening Wires to Improve Colonoscopy

结肠镜检查可能是具有挑战性的执行和痛苦的病人由于结肠镜的循环。当结肠镜的进一步插入没有导致尖端的前进，而是导致结肠镜轴形成环时，就会发生环。为解决这个问题作了许多尝试，取得了不同程度的成功。到目前为止，还没有完美的循环解决方案。由于结肠内窥镜检查是结肠癌筛查和诊断许多结肠疾病的金标准，因此提供一种可以防止循环并确保更完整和更舒适的检查的设备将是有价值的。我们已经开发了一种实验装置，该装置在本研究背景之外尚未获得批准，称为节段加强钢丝（SSW），以防止再环。如果通过内窥镜的活组织检查通道发生环，则使用该导线。钢丝的厚度和刚度增加了15-25英寸。钢丝的加劲部分在减少后可以推进到环区，以防止再环。我们将对SSW进行一项试点研究，其中将包括大约10名健康志愿者，他们将使用成人结肠镜进行结肠镜检查，如果发生循环，则进行SSW检查。这将使研究内窥镜医师熟悉该设备，并将使用透视检查记录环，并确定该设备是否可以防止再次环。如果无法获得足够多的愿意接受双重结肠镜检查的志愿者，那么愿意接受单次结肠镜检查的患者将被纳入其中，他们的手术将以随机的方式在有或没有SSW的情况下进行。终点为盲肠插管时间；镇静/镇痛量；所需辅助机动次数；通过视觉模拟疼痛量表、修改后的COMFORT量表和Ramsey镇静量表测量疼痛/镇静程度；生命体征变化；以及内窥镜医师对SSW的操作难度和有用性的主观评估。

Colonoscopy can be challenging to perform and painful for the patient due to looping of the colonoscope. Looping occurs when further insertion of the colonoscope does not result in advancement of the tip, but instead results in a loop forming in the shaft of the colonoscope. Many attempts have been made with varied success to solve this problem. To date there is no perfect solution to looping. Since endoscopic examination of the colon is the gold standard for colon cancer screening and diagnosing many diseases of the colon, providing a device that could prevent looping and assure a more complete and more comfortable examination would be valuable. We have developed an experimental device that has not been approved outside of the context of this study known as the Segmental Stiffening Wire (SSW) to prevent re-looping. This wire will be utilized if looping occurs by passing it through the biopsy channel of the endoscope. The wire has a 15-25 inch area of increased thickness and stiffness. The stiffened section of the wire can be advanced into areas of looping, after reduction, in an effort to prevent re-looping. We will conduct a pilot study of the SSW that will include approximately 10 healthy volunteers who will undergo colonoscopy using an adult colonoscope and, if looping occurs, the SSW. This will allow the study endoscopists to gain familiarity with the device and will use fluoroscopy to document looping and to determine if the device prevents re-looping. If unable to obtain sufficient volunteers willing to undergo dual colonoscopy, then patients willing to undergo single colonoscopy will be included and their procedures will be done either with or without the SSW in a random fashion. The endpoints will be cecal intubation time; quantity of sedation/analgesia; number of required ancillary maneuvers; pain/sedation as measured by the visual analog pain scale, a modified COMFORT scale, and the Ramsey Sedation Scale; vital sign changes; and the endoscopists subjective assessment of procedure difficulty and usefulness of the SSW. Only seven patients have been enrolled into the first phase of the study. Therefore, no research accomplishments can be summarized at this time.