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: 10557387
• 负责人: Kenton Dodyan Fong
• 金额: $ 5.5万
• 依托单位: SAVAGE MEDICAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-22 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10557387
• 关键词: Anastomosis - action; Anatomy; Animal Model; Animal Testing; Clinical Trials; Colon; Cost Savings; Crohn' s disease; Development; Devices; Disease; Diverticulitis; Excision; Funding; Health Care Costs; Healthcare Systems; Human; Inflammatory Bowel Diseases; Ischemic Bowel Disease; Maintenance; Medical; Medical Device; Morbidity - disease rate; Operative Surgical Procedures; Ostomy; Patients; Quality of life; Rectal Cancer; Safety; Technology; Testing; Translating; Ulcerative Colitis; Validation; cancer surgery; cost; design; mortality; novel; psychologic; surgery outcome; wound

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.

直肠癌结肠切除术后，吻合口瘘可发生在高达36%的患者