A Device to Reduce Anastomotic Failure in the Treatment of Colorectal Cancer

描述(申请人提供)：吻合口失败是胃肠道手术最可怕的并发症之一，因为由此导致的发病率和死亡率。尽管手术技术得到了改进，手术吻合器的使用也得到了广泛的接受，但考虑到严重的后果，以渗漏或狭窄形式出现的吻合口失败的发生率仍高得令人无法接受。在施行低位前切除术(LAR)切除直肠癌时，已有高达30%的病例报告发生吻合口失败。一项对2729名患者进行的大型多中心观察性研究报告了14.3%的漏率。这些吻合口失败会给医疗保健系统带来重大的、可以避免的经济负担，也会给发生吻合口失败的患者带来无法估量的痛苦、痛苦和困难。作为预防措施，许多外科医生会将肠道近端的一段穿过腹壁，形成分流的吻合口。这一操作的基本原理是防止新形成的吻合口的潜在失败导致粪便渗入腹膜腔。许多时候，外科医生会在最初的手术几个月后再进行另一次手术来逆转吻合口。在同一项多中心研究中，881名患者接受了临时分流吻合口以降低吻合口漏的风险，然而，在这组患者中，只有128名患者发生了吻合口漏。因此，高达85%的患者接受了额外的外科手术来逆转造口，这提供了可疑的好处。随意建立临时的分流吻合口，以及最终的逆转手术，给医疗保健系统带来了重大的、可以避免的经济负担，并使许多患者暴露在可以说是不必要的手术风险中。目前，还没有一种临床实用的方法或装置来预测吻合口的失败，也没有客观的标准可以让手术团队决定何时需要改道造口。我们的目标是创造一种临床上透明的装置，通过在吻合口建立之前、期间和之后对靶组织的分析来减少吻合口失败。如果组织被认为不适合可靠地形成吻合口，该装置会提醒手术团队采取纠正措施。我们的方法是设计一种设备：通过耦合到商用的现成手术吻合器集成到手术工作流程中，使用多模传感器阵列来评估吻合线上组织的生存能力，并将传感器数据无线传输到基站，在那里向手术团队显示实时反馈。第一阶段将重点评估和选择能够在保持临床和商业可行性的同时评估组织活性的传感方式，以及将在第二阶段开发和评估的临床级设备的设计。公共卫生相关性：拟议的研究是实现临床透明设备的第一步，该设备能够提供目前手术团队无法获得的吻合口活性的实时评估；手术团队将能够采取适当的措施，通过确保足够的组织灌流来减少吻合口失败。建议的装置将帮助手术团队客观地确定最佳的吻合口间隙，最大限度地减少吻合口的张力，并指示何时建立分流造口或提供替代疗法符合患者的最佳利益。拟议中的设备可以显著减少患者的痛苦，同时每年节省20亿美元的额外医疗成本。

DESCRIPTION (provided by applicant): Anastomotic failure is one of the most feared complications of gastrointestinal surgery due to the resultant morbidity and mortality. Failure of an anastomosis, or intestinal junction, can cause a spectrum of morbidities to the patient including local abscess formation - requiring procedural drainage, tumor recurrence, debilitating pain, dysfunctional defecation, and overwhelming bacterial sepsis resulting in death. Despite improvements in surgical technique, and the widely accepted use of surgical staplers, anastomotic failure in the form of leakage or stricture occurs at unacceptable high levels given the severe consequences. In the performance of a low anterior resection (LAR) for excision of rectal cancer, anastomotic failure has been reported to occur in up to 30% of cases. One large multicenter, observational study of 2729 patients reported a leak rate of 14.3%. These anastomotic failures cause a significant and avoidable economic burden on the healthcare system, as well as an incalculable amount of pain, suffering, and hardship for the patients in which the failure occurs. As a precaution many surgeons will tunnel a proximal segment of the bowel through the abdominal wall to form a diverting stoma. The rationale of this maneuver is to prevent the leakage of fecal matter into the abdominal cavity from a potential failure at the newly formed anastomotic site. Many times the surgeons will perform another procedure to reverse the stoma months after the initial procedure. In the same multicenter study 881 patients were given a temporary diverting stoma to mitigate the risk of an anastomotic leak, however, within this group only 128 patients developed a leak. Thus up to 85% of those patients underwent an additional surgical procedure to reverse the stoma that provided questionable benefit. The arbitrary creation of a temporary diverting stoma, and the eventual reversing procedure presents a significant and avoidable economic burden on the healthcare system, as well as exposes numerous patients to arguably unnecessary surgical risk. Presently, there is neither a clinically practical method nor device available for predicting anastomotic failure, nor objective criteria by which the operative team can decide when a diverting stoma is indicated. Our objective is to create a clinically transparent device that reduces anastomotic failures through analysis of target tissues before, during, and after creation of an anastomosis. If the tissues are deemed unsuitable for reliable formation of an anastomosis, the device alerts the operative team to take corrective action. Our approach is to design a device that: integrates into the surgical workflow by coupling to a commercially available, off-the-shelf surgical stapling instrument, employs an array of multimodality sensors to assess the viability of the tissues at the staple line, and wirelessly transmits sensor data to a base station where the real-time feedback is displayed to the operative team. Phase I will focus on evaluation and selection of sensing modalities that are capable of assessing tissue viability while maintaining clinical and commercial feasibility, and design of the clinical grade device to be developed and evaluated in Phase II. PUBLIC HEALTH RELEVANCE: The proposed research is the first step to realizing a clinically transparent device capable of providing real-time assessment of anastomotic viability not currently available to the operative team; the operative team will be able to take appropriate measures to reduce anastomotic failures by ensuring adequate tissue perfusion. The proposed device will assist the operative team by objectively determining the optimal staple gap, minimizing tension across the anastomosis, and indicating when the creation of a diverting ostomy or the provision of an alternative therapy is in the best interest of the patient. The proposed device could significantly reduce patient suffering, while saving $2 billion dollars annually in excess healthcare costs.