A Trial of Segmental Stiffening Wires to Improve Colonoscopy

分段硬化钢丝改善结肠镜检查的试验

• 批准号: 7967784
• 负责人: Stephen Wank
• 金额: $ 25.31万
• 依托单位: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7967784
• 关键词: Absence of pain sensation; Adult; Area; Biopsy; Colon; Colon Carcinoma; Colonoscopes; Colonoscopy; Devices; Diagnosis; Disease; Effectiveness; Endoscopes; Enrollment; Familiarity; Fluoroscopy; Gold; Intubation; Measures; Pain; Patients; Phase; Pilot Projects; Problem Solving; Procedures; Research; Screening procedure; Sedation procedure; Solutions; Thick; Time; Visual Analogue Pain Scale; healthy volunteer; improved; prevent; success; volunteer

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.

结肠镜检查可能具有挑战性，并且由于结肠镜的循环而使患者感到疼痛。 当结肠镜的进一步插入没有导致尖端的前进，而是导致在结肠镜的轴中形成环时，发生环。 已经进行了许多尝试，取得了不同的成功来解决这个问题。 到目前为止，还没有一个完美的循环解决方案。 由于结肠的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成环并确保更完整和更舒适的检查的装置将是有价值的。 我们开发了一种实验性器械，该器械尚未在本研究范围外获得批准，称为节段性加强丝（SSW），以防止再次成环。 如果通过内窥镜的活检通道形成环，则将使用该导丝。 该金属丝具有15-25英寸的增加厚度和刚度的区域。 钢丝的加强段可在复位后进入成环区域，以防止再次成环。 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，则使用SSW。 这将使研究内窥镜医师熟悉器械，并将使用荧光镜检查记录成环并确定器械是否防止再成环。 如果无法获得足够的愿意接受双结肠镜检查的志愿者，则将纳入愿意接受单结肠镜检查的患者，并以随机方式在有或无SSW的情况下完成其手术。 终点将是盲肠插管时间;镇静/镇痛量;所需辅助操作次数;通过视觉模拟疼痛量表、改良的COMFORT量表和Ramsey镇静量表测量的疼痛/镇静;生命体征变化;以及内窥镜医师对手术难度和SSW有用性的主观评估。 只有7名患者被纳入研究的第一阶段。 因此，目前无法总结任何研究成果。