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

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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.