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

描述（由申请人提供）：由于导致发病率和死亡率，吻合失败是胃肠道手术最可怕的并发症之一。吻合术或肠连接失败可导致患者一系列疾病，包括局部脓肿形成-需要手术引流、肿瘤复发、衰弱性疼痛、排便功能障碍和导致死亡的压倒性细菌败血症。尽管手术技术有所改进，并且外科吻合器的使用被广泛接受，但考虑到严重后果，以泄漏或狭窄形式出现的吻合失败的发生率高得不可接受。在低位前切除术（LAR）切除直肠癌时，据报道，吻合失败的发生率高达30%。一项纳入2729例患者的大型多中心观察性研究报告的泄漏率为14.3%。这些吻合失败对医疗保健系统造成显著且可避免的经济负担，以及对发生吻合失败的患者造成无法估量的疼痛、痛苦和困难。作为预防措施，许多外科医生会将肠的近端部分穿过腹壁，形成一个转向造口。该操作的基本原理是防止新形成的吻合部位的潜在失败导致粪便渗漏到腹腔中。很多时候，外科医生会在最初的手术后几个月进行另一个手术来逆转造口。在同一项多中心研究中，881例患者接受了临时分流造口以降低吻合口瘘的风险，然而，该组中仅128例患者发生了吻合口瘘。因此，高达85%的患者接受了额外的外科手术，以扭转造口，提供可疑的好处。临时分流造口的任意创建以及最终的逆转程序对医疗保健系统造成了重大且可避免的经济负担，并且使许多患者暴露于可以说是不必要的手术风险。目前，既没有临床上实用的方法，也没有设备可用于预测吻合失败，也没有客观的标准，手术团队可以决定何时转向造口指示。我们的目标是创建一种临床上透明的器械，通过在创建吻合之前、期间和之后分析靶组织来减少吻合失败。如果认为组织不适合可靠地形成吻合，则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器械，该器械通过与市售现成的外科吻合器械耦合而集成到手术工作流程中，采用多模态传感器阵列来评估吻合线处组织的活力，并将传感器数据无线传输到基站，在基站中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评估组织活力同时保持临床和商业可行性的传感模式，以及将在第二阶段开发和评估的临床级器械的设计。公共卫生相关性：拟议的研究是实现临床透明器械的第一步，该器械能够提供手术团队目前无法获得的吻合可行性的实时评估;手术团队将能够采取适当措施，通过确保充分的组织灌注来减少吻合失败。申报器械将通过客观确定最佳缝钉间隙、最小化吻合口张力以及指示何时创建转向造口术或提供替代治疗符合患者的最佳利益来协助手术团队。该设备可以大大减少患者的痛苦，同时每年节省20亿美元的额外医疗费用。

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.