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

项目摘要/摘要 结直肠癌是第三种最常见的癌症，约30%-40%的病例累及直肠。 直肠癌通常采用新辅助治疗和手术切除。然而，吻合术 高达10%-18%的患者在切除后会发生渗漏，相关的高死亡率是由于严重的 腹部败血症。目前，分流造口通常放置在吻合口上方，以减轻 吻合口漏的严重后果，但临时造口本身是高度病态的， 有很大的死亡风险，对医疗保健系统来说代价高昂，并严重影响患者的 生活质量。由于大多数患者不会出现严重的吻合口漏，因此大多数患者 接受临时造口的人最终并不需要它们。有医学上的需要 为吻合口提供保护，以防止渗漏的严重后果，而不会发生并发症 临时造口。萨维奇医疗公司开发了一种腔内粪便分流装置，该装置利用 一种安全、可靠、易于可逆的新型锚定机构，不需要 大多数直肠癌患者的临时造口手术。这项技术只允许那些小的 发生严重渗漏的患者中，有1%的患者会在保留绝大多数患者的情况下接受造口手术 直肠癌患者不需要造口。消除了临时造口的需要 平均每个患者在直接手术费用(造口手术和翻转手术)方面节省超过25000美元 消除每位患者每年8.5万美元的造口维护费用。患者的生活质量 避免造口由于这项技术也将在他们的癌症治疗过程中得到深刻的改善。 这个拟议的项目是在一个 这种新型医疗器械的吻合口漏模型。

PROJECT SUMMARY/ABSTRACT Colorectal cancer is the third most common cancer with about 30-40% of cases involving the rectum. Rectal cancer is typically treated with neoadjuvant therapy and surgical resection. However, anastomotic leaks can occur in up 10-18% of patients after resection with an associated high mortality due to severe abdominal sepsis. Currently, diverting ostomies are typically placed above the anastomosis to mitigate the severe consequences of an anastomotic leak, but temporary ostomies themselves are highly morbid, have significant risk of mortality, are expensive to the healthcare system, and drastically impact patient’s quality of life. Because the majority of patients do not develop severe anastomotic leaks, most patients who receive temporary ostomies end up not actually requiring them. There exists a medical need to provide protection to an anastomosis to prevent the severe consequences of leaks without the morbidity of a temporary ostomy. Savage Medical has developed an intraluminal fecal diversion device that utilizes a novel anchoring mechanism that is safe, reliable, easily reversible, and eliminates the need for temporary ostomy surgery for most rectal cancer patients. This technology allows for only those small percent of patients who develop severe leaks to undergo ostomy surgery while sparing the vast majority of rectal cancer patients from requiring an ostomy. Eliminating the need for a temporary ostomies would on average save over $25K per patient in direct surgical costs (ostomy surgery and reversal surgery) and eliminate $8.5K per patient in annual ostomy maintenance costs. The quality of life for patients who would avoid ostomies due to this technology would also be profoundly improved during their cancer treatment. This proposed project is to perform design verification testing and large animal validation testing in an anastomotic leak model for this novel medical device.