A Novel Device Alternative to Temporary Diverting Ostomies after Rectal Cancer Surgery

在直肠癌结肠切除术后，高达36%的直肠癌患者可能发生吻合口瘘。 死亡率高达22%。目前，转移造口术通常放置在吻合口上方以保护 防止泄漏和泄漏的后果，但造口术是高度病态和昂贵的医疗保健 系统萨维奇医疗正在开发一种腔内粪便分流技术， 安全、可靠、容易逆转并消除临时造口术的需要的锚定机构 手术我们已经在短期研究中测试了我们的设备，以证明 技术.在美国，每年有超过30万例造口手术，其中大多数 可以随着所提出的技术的发展而消除。消除了临时 造口平均可为每位患者节省超过2.5万美元的直接手术费用，并为每位患者减少8.5万美元 每年的维护费用。萨维奇医疗公司的专有技术现在已经到了 需要在解剖动物模型中进行长期测试以完成和验证设计。拟议 项目是资助大型动物试验，可能的设计修订要求，并验证这一新的 作为人体临床试验的先驱。

After colon resections for rectal cancer, anastomotic leaks can occur in up to 36% of patients with a mortality of up to 22%. Currently, diverting ostomies are often placed above the anastomosis to protect against leaks and the consequences of leaks, but ostomies are highly morbid and expensive to the healthcare system. Savage medical is developing an intraluminal fecal diversion technology that utilizes a novel anchoring mechanism that is safe, reliable, easily reversible, and eliminates the need for temporary ostomy surgery. We have tested our device in short term studies to demonstrate the function and safety of the technology. There are more than 300,000 ostomies performed each year in the US, and a majority of these can be eliminated with the development of the proposed technology. Eliminating the need for a temporary ostomy would on average save over $25K per patient in direct surgical costs and eliminate $8.5K per patient in annual maintenance costs. The Savage Medical's proprietary technology is now at the stage where long term testing in anatomic animal models is required to complete and validate the design. The proposed project is to fund large animal testing, possible design revision requirements, and validation of this novel device as a precursor to human clinical trials.