Dye-free, multimodal, quantitative imaging to assess bowel perfusion during laparoscopic colorectal resection

吻合口漏(AL)是肠道手术的严重并发症，其原因很多。 据报道，这种并发症的死亡率从6%到39%不等。最好的时机是 防止可能发生的AL发生在手术室中。由于以下原因可能会发生泄漏 技术上的错误，但它经常发生的结果是肠道血运不佳。 建立健康和安全的肠吻合需要有良好的血液供应两端 肠子要连接起来。术中诊断灌流良好的肠道的工具有限。 而且往往依赖于外科医生的主观评价。这是有问题的，特别是在 肠道看起来“暗淡”或受到威胁，但没有明显坏死的情况。这个 外科医生可以利用浆膜显影和肠系膜血管触诊，但失败了。 以评估肠道本身的微血流灌注情况。此外，大多数研究都是关于 在结直肠手术中采用腹腔镜技术显示使用率增加(55.4% 2009至2012年间，共有309,816名患者接受了择期结肠切除术 均为微创手术)。然而，使用腹腔镜手术或 微创手术在确定肠道存活率方面可能更不可靠。 由于缺少肉眼触诊。 在这项研究中，我们建议开发一种无染料的、多模式的腹腔镜成像系统，用于 定量评估肠道灌注量对手术指导的指导作用 腹腔镜(和开腹)肠道手术。光外科有限责任公司是一家小型企业， 与国立儿童医院的研究人员建立了牢固的合作伙伴关系， 在那里，专业临床医生和工程师将提供必要的临床见解 建议技术的全面开发、临床前验证和临床翻译 从替补席到手术室。 这项为期一年的研究计划的目标是开发和评估新的多模式成像 通过以下特定目标进行腹腔镜吻合术的摄像系统；目标1：原型 多模式摄像系统，并将该系统集成到商用的 腹腔镜；目标2：在活体猪肠道模型中验证该系统的临床前 缺血(n=12)。 在第一期工程顺利完成后，我们会进行第二期研究。 其中我们将准备一个临床级设备，并使用猪模型进行动物研究 统计验证，随后进行了一项针对人类受试者的试点临床研究。这种新的光学元件 成像技术在评估肠道血流灌注和潜在的内在功能方面大有可为 肠道疾病，目标是减少术后发病率/死亡率和二次检查 疑似肠漏的手术。

Anastomotic leak (AL) is a serious complication of intestinal surgery, with many potential causes. This complication carries with it a reported mortality ranging from 6 to 39%. The best time to prevent a possible AL is during its creation in the operating room. A leak can occur due to a technical error, but frequently it occurs as a consequence of poorly vascularized intestine. Creating a healthy and safe intestinal anastomosis requires a good blood supply to the two ends of bowel to be joined. The tools for diagnosing well-perfused bowel intraoperatively are limited and often rely on the subjective evaluation of the surgeon. This is problematic especially in circumstances in which the bowel appears to be "dusky" or threatened but not clearly necrotic. The surgeon can utilize serosal visualization and palpation of the mesenteric vessels, but this fails to evaluate the micro-perfusion of the intestine itself. In addition, most of the research on adoption of laparoscopic techniques in colorectal surgery shows increased rates of use (55.4% of the total of 309,816 patients who underwent elective colon resection between 2009 and 2012 were performed minimally invasively). However, techniques using laparoscopic surgery or minimally invasive surgery (MIS) can be even less reliable for determining bowel viability due to lack of gross palpation. In this research, we propose to develop a dye-free, multimodal laparoscopic imaging system for the quantitative assessment of bowel perfusion for precise surgical guidance during laparoscopic (and open) intestinal surgery. Optosurgical, LLC is a small business that has established a strong partnership with researchers at Children's National Hospital, where expert clinicians and engineers will provide requisite clinical insight on the full development, preclinical validation, and clinical translation of the proposed technology from the bench to the operating room. The goal of this 1-year research proposal is to develop and evaluate the novel multimodal imaging camera system for laparoscopic anastomosis through the following specific aims; Aim 1: To prototype the multimodal camera system and integrate the system into a commercially available laparoscope; Aim 2: To validate the system pre-clinically in a swine model of in vivo intestinal ischemia (n=12). Upon successful completion of this STTR Phase 1 project, we will proceed with the Phase 2 studies, wherein we will prepare a clinical grade device and execute animal studies using a swine model with statistical validation, followed by a pilot clinical study on human subjects. This new optical imaging technology holds great promise for evaluating bowel perfusion and potential intrinsic intestinal disorders with the goal of reducing postoperative morbidity/mortality and second-look operations for suspected intestinal leaks.