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 limitedand 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 thequantitative 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. Public Health Relevance Statement Anastomotic leak (AL) is a dreaded complication of intestinal surgery, with many potential causes. We will develop a multimodal dye-free imaging camera system that will define and delineate bowel viability suitable for guiding intestinal resection and anastomosis during surgery. The technology will be validated in large animal survival studies.
Project Terms: Adoption ; Angiography ; Angiogram ; angiographic imaging ; Animals ; Blood Vessels ; vascular ; Child ; 0-11 years old ; Child Youth ; Children (0-21) ; youngster ; Clinical Research ; Clinical Study ; Colon ; Colorectal Surgery ; Colon and Rectal Surgery ; colon and rectum surgery ; Color ; Complication ; Contrast Media ; Contrast Agent ; Contrast Drugs ; Radiopaque Media ; Statistical Data Interpretation ; Statistical Data Analyses ; Statistical Data Analysis ; statistical analysis ; Cessation of life ; Death ; Diagnosis ; Dyes ; Coloring Agents ; Engineering ; Extravasation ; Leakage ; Spillage ; Face ; faces ; facial ; Fluorescence ; Fluorescent Dyes ; Fluorescence Agents ; Fluorescent Agents ; fluorescent dye/probe ; Goals ; Health ; Hemorrhage ; Bleeding ; blood loss ; Hospitals ; Indocyanine Green ; Ujoveridin ; Wofaverdin ; Inflammatory Bowel Diseases ; Inflammatory Bowel Disorder ; Intestinal Diseases ; Intestinal Disorder ; intestine disease ; intestine disorder ; Intestines ; Intestinal ; bowel ; Laparoscopes ; Celioscopes ; Peritoneoscopes ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Magnetic Resonance Imaging ; MR Imaging ; MR Tomography ; MRI ; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance ; NMR Imaging ; NMR Tomography ; Nuclear Magnetic Resonance Imaging ; Zeugmatography ; Manuals ; men ; men's ; Mesentery ; Mesenteric ; Methods ; Microcirculation ; Morbidity - disease rate ; Morbidity ; mortality ; Mosaicism ; mosaic disorders ; Necrosis ; Necrotic ; Operating Rooms ; Optics ; optical ; Palpation ; Legal patent ; Patents ; Patients ; Perfusion ; Peristalsis ; Laparoscopy ; Celioscopy ; Diagnostic Laparoscopy ; Peritoneoscopy ; Personal Satisfaction ; well-being ; wellbeing ; Pilot Projects ; pilot study ; Play ; Postoperative Care ; post-operative care ; Postoperative Period ; Post-Operative ; Postoperative ; Ionizing radiation ; Ionizing Electromagnetic Radiation ; Radiation-Ionizing Total ; ionizing output ; Research ; Research Personnel ; Investigators ; Researchers ; Research Proposals ; Risk ; Family suidae ; Pigs ; Suidae ; Swine ; porcine ; suid ; Technology ; Technology Assessment ; Time ; Tissues ; Body Tissues ; X-Ray Computed Tomography ; CAT scan ; CT X Ray ; CT Xray ; CT imaging ; CT scan ; Computed Tomography ; Tomodensitometry ; X-Ray CAT Scan ; X-Ray Computerized Tomography ; Xray CAT scan ; Xray Computed Tomography ; Xray computerized tomography ; catscan ; computed axial tomography ; computer tomography ; computerized axial tomography ; computerized tomography ; Ultrasonography ; Echography ; Echotomography ; Medical Ultrasound ; Ultrasonic Imaging ; Ultrasonogram ; Ultrasound Diagnosis ; Ultrasound Medical Imaging ; Ultrasound Test ; diagnostic ultrasound ; sonogram ; sonography ; sound measurement ; ultrasound ; ultrasound imaging ; ultrasound scanning ; United States ; Vision ; Sight ; visual function ; Woman ; Imaging Techniques ; Imaging Procedures ; Imaging Technics ; Businesses ; Fluorescence Angiography ; Ischemic Bowel Disease ; intestinal ischemia ; Secondary to ; base ; human subject ; Label ; improved ; Procedures ; intestine surgery ; Area ; Surface ; Clinical ; Phase ; Evaluation ; insight ; Collaborations ; Exposure to ; tool ; Pulse ; Physiologic pulse ; Techniques ; System ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Colon or Rectum ; colo-rectal ; colorectum ; Colorectal ; Surgeon ; experience ; Performance ; Anastomosis ; Anastomosis - action ; novel ; Devices ; Colon Cancer ; Colonic Carcinoma ; cancer in the colon ; Colon Carcinoma ; Reporting ; Touch ; tactile sensation ; Touch sensation ; Abscission ; Extirpation ; Removal ; Surgical Removal ; resection ; Excision ; Laparoscopic Surgery ; laparoscopy-assisted surgery ; Laparoscopic Surgical Procedures ; Modeling ; rapid method ; rapid technique ; develop software ; developing computer software ; software development ; tissue oxygen saturation ; tissue oxygenation ; blood supply ; vascular supply ; Vascular blood supply ; Second Look ; Surgical Revision ; Second Look Surgery ; intra-operative imaging ; intraoperative imaging ; surgical imaging ; Image-Guided Surgery ; preventing ; prevent ; Tissue Viability ; multi-modal imaging ; multi-modality imaging ; multimodality imaging ; Multimodal Imaging ; in vivo Model ; Cancer Etiology ; Cancer Cause ; Patient-Focused Outcomes ; Patient outcome ; Patient-Centered Outcomes ; Small Business Technology Transfer Research ; STTR ; Validation ; Resected ; Process ; Development ; developmental ; Colorectal Cancer ; Colo-rectal Cancer ; Image ; imaging ; pre-clinical ; preclinical ; optical imaging ; optic imaging ; Clinical assessments ; Outcome ; Imaging technology ; Impairment ; Cancerous ; prototype ; multimodality ; multi-modality ; minimally invasive ; phase 2 study ; phase II study ; operation ; quantitative imaging ; Near-infrared optical imaging ; NIR imaging ; NIR optical imaging ; Near-infrared Fluorescence Imaging ; near infrared imaging ; imaging platform ; imaging system ; clinical translation ; Laser Speckle Imaging ; laser speckle contrast imaging ; perfusion imaging ; colorectal cancer treatment ; colo-rectal cancer therapy ; colo-rectal cancer treatment ; colorectal cancer therapy ; Injections ; preservation ; Visualization ; effectiveness evaluation ; assess effectiveness ; determine effectiveness ; effectiveness assessment ; evaluate effectiveness ; porcine model ; pig model ; piglet model ; swine model ;
