safety and feasibility of activsighttm in human

Conditions: Acute Cholecystitis; Colorectal Cancer; Diverticulitis, Colonic; Obesity, Morbid; Inflammatory Bowel Diseases

Summary: activsighttm combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. a small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively. primary objective: to determine safety and feasibility of activsighttm in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery. secondary objective: to determine the efficacy of activsighttm in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (icg) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using icg-based intraoperative cholangiography (ioc).

design: * this is a feasibility study designed to evaluate safety and feasibility of activsighttm in gastrointestinal anastomoses and cholecystectomy. * safety will be determined through clinical assessments and evaluation of any adverse event. * feasibility will be determined through technically successful completion of intended visualization. * assessment of preliminary efficacy will be performed through analysis of any intraoperative decisions made based on visual display as compared to standard endoscopic approach, or non-inferiority to icg-based visualization and usability. * patients outcome and follow up to postoperative day 28 will be monitored for clinical outcome. * target enrollment for the assessment of 80 patients; 52 evaluating intestinal anastomoses cases (including bariatric and colorectal cases); and 28 evaluating laparoscopic cholecystectomy. stopping rules are triggered following the first 6 patients and a comparison group 6 patients in icg-based treatment.

Eligibility criteria:
inclusion criteria: * all patients age \>= 18 years old undergoing laparoscopic or robot assisted intestinal anastomoses, or all patients age \>= 18 years old who are planned for laparoscopic cholecystectomy; spoken command and literacy in the native language spoken at each participating center; ability to understand and follow study procedures; and having provided signed consent. * diagnosis: * all patients with a clinical suspicion and diagnosis of benign or malignant, small or large bowel lesions requiring surgical resection. * all patients with clinical suspicion and diagnosis of symptomatic cholelithiasis or cholecystitis planned for cholecystectomy. * typical imaging as per standard workup findings including us, ct and/or mri. plain radiographs and contrast imaging may be obtained by referring physicians and are helpful for confirming the clinical diagnosis. * any bariatric patients undergoing gastric sleeve or bypass. * any pediatric patient undergoing laparotomy for necrotizing enterocolitis * location of pathology or resected segment: * target lesions can be located in any fore-, mid- or hindgut segments requiring reconstruction and anastomoses. * prior therapy: * patients with prior surgery are eligible for enrollment. * laboratory: * hemoglobin \> 9 g/dl * platelet count ≥75,000/μl (may receive transfusions) * normal prothrombin time, tested prothrombin, and international normalized ratio \< 1.5 x upper limit of normal (uln) (including patients on prophylactic anticoagulation) * renal function: age-adjusted normal serum creatinine derived from schwartz formula for estimating glomerular filtration rate by the centers for disease control (cdc) or a creatinine clearance ≥60 ml/min/1.73 m2 for safe * adequate pulmonary function: defined as no dyspnea at rest, and a pulse oximetry \>94% on room air if there is clinical indication for determination. exclusion criteria: * there is no exclusion criteria for activsighttm for gastrointestinal resection. * patients assigned to fda cleared icg-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to icg or anaphylaxis, and pregnancy. * patients eligible for cholecystectomy, exclusion criteria include known allergy to iodides; known history of cholangitis, pancreatitis, prior common bile duct injury, coagulopathy or known, preexisting liver disease; pregnancy or breast-feeding; or being of reproductive age with pregnancy possible and not ruled out. * patients currently in any investigational agents.

Keywords: laparoscopic robot assisted surgery gastrointestinal anastomoses cholecystectomy colorectal surgery bariatric surgery vascularity perfusion icg laser speckle contrast imaging