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

直肠癌手术后临时改道造口的新型替代装置

• 批准号: 10152724
• 负责人: Kenton Dodyan Fong
• 金额: $ 29.85万
• 依托单位: SAVAGE MEDICAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-10 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10152724
• 关键词: Abdomen; Abdominal Cavity; Anastomosis - action; Animals; Autopsy; Award; Bypass; Cancer Patient; Chronic; Clinical; Clinical Trials; Colon; Colorectal Cancer; Complication; Cost Savings; Crohn' s disease; Development; Device Designs; Device Removal; Devices; Disease; Diverticulitis; Ensure; Equipment Malfunction; Evaluation; Excision; Failure; Family suidae; Funding; Health Care Costs; Healthcare Systems; Human; Ileostomy; Industry Standard; Inflammatory Bowel Diseases; Intestines; Ischemic Bowel Disease; Joints; Laboratories; Life; Logistics; Maintenance; Malignant Neoplasms; Measures; Mechanics; Medical; Medical Device; Modeling; Morbidity - disease rate; Neoadjuvant Therapy; Operative Surgical Procedures; Ostomy; Patients; Pelvis; Performance; Perfusion; Phase; Pilot Projects; Preparation; Prevention; Process Assessment; Protocols documentation; Quality of life; Rectal Cancer; Rectum; Request for Proposals; Research Design; Risk; Sample Size; Sepsis; Severities; Site; Small Business Innovation Research Grant; Surgeon; Technology; Testing; Time; Translating; Ulcerative Colitis; Validation; Visual; Weight; cancer surgery; cancer therapy; clinical risk; cost; cost effective; design; healing; health care economics; improved; ischemic injury; mechanical device; mortality; mortality risk; novel; patient safety; porcine model; pressure; prevent; psychologic; success; surgery outcome; wound

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.

项目总结/摘要 结直肠癌是第三大常见癌症，约30-40%的病例涉及直肠。 直肠癌通常采用新辅助治疗和手术切除治疗。然而，吻合 10-18%的患者在切除术后会发生渗漏，由于严重的 腹部败血症。目前，转向造口术通常放置在吻合口上方，以减轻 吻合口漏的严重后果，但临时造口术本身是高度病态的， 具有显著的死亡风险，对医疗保健系统来说是昂贵的，并且极大地影响患者的 生活质量由于大多数患者不会发生严重的吻合口漏， 接受临时造口手术的人最终并不需要医学上需要 为吻合口提供保护，以防止泄漏的严重后果，而不会导致发病率 临时造口Savage Medical开发了一种管腔内粪便分流装置， 一种新颖的锚固机构，其安全、可靠、容易反转，并且消除了对 直肠癌患者的临时造口术。这项技术只允许那些 发生严重渗漏的患者接受造口术手术的百分比，而绝大多数患者则不会接受造口术手术。 直肠癌患者不需要造口术。消除临时造口术的需要将 平均每位患者节省超过2.5万美元的直接手术费用（造口手术和逆转手术）， 减少了每位患者每年8500美元的造口维护成本。患者的生活质量 由于这项技术，避免造口术也将在癌症治疗期间得到深刻的改善。 本拟议项目旨在在一个试验室中进行设计验证试验和大型动物确认试验。 这种新型医疗器械的吻合口漏模型。