Quantitative assessment of the troCarWash™ system for automated laparoscopic camera cleaning

Disruption of surgical workflow has obvious unfavorable implications on the care of patients, and disruptions in the flow of surgery have in fact been shown to result in surgical errors [8]. One of the predominant reasons for such disruption in MIS is unnecessary extracorporeal distraction including the necessary frequent cleaning of the surgical endoscope [9]. Further, the current practice of cleaning the surgical endoscope by completely removing it from the surgical field results in an unavoidable period of complete loss of surgical visualization. Such practice can amplify the severity of acute problems such as the bleeding which may be responsible for the impaired vision. It seems reasonable to submit that a solution for restoring surgical visualization rapidly and without removing the camera from the surgical field, and that maintains better visualization throughout the surgical procedure, could limit the severity of adverse events and improve patient safety.

To this end, we developed a device that maintains surgical visualization by rapid, in vivo, minimal effort cleaning of the frequently soiled endoscope. This animal study was completed prior to the recent FDA clearance of this device and was designed to test its efficacy of cleaning in a relevant large animal model of laparoscopy. In the hands of board-certified general surgeons who had never before seen this device, and with less than 5 min of informal training, our data show that the troCarWash™ effectively and reproducibly restores visualization of the surgical field following common in vivo soilage events.

To increase the rigor of our investigation, we used two modes to evaluate image clarity. First, we used a digital algorithm. We chose the canny edge detection algorithm as the cognitive detection of edges is one of the most basic levels of visual processing used by the brain for higher-level object recognition [10]. Simply speaking, the human brain processes images by determining edges. Second, we used a subjective, semi-quantitative method for grading image clarity, performed by 3 unbiased observers who were unaware of the experimental design and simply asked to score the clarity of laparoscopy images. By each method, and for each surgeon, the troCarWash™ significantly restored visual clarity. The strength of this conclusion is supported further by our finding of statistical correlation between digital deconvolution and semiquantitative observations.

Additional benefits of a rapid, effective, and intuitive use device for in vivo cleaning of the surgical camera includes reducing operating room time, which subjects patients to increased risks related to extended hypoperfusion from anesthesia and surgical site infection [11]. Additionally, operating room time is expensive, and its reduction could consequently reduce burden on the health care system [12]. Further, and not to be understated, is that this problem is highly frustrating to surgeons [1, 3] and other members of the operating room team including learners, assistants, and staff. Although perhaps not rigorously studied, a frustrated operating room can have unfavorable consequences that extend past morale.

Our study was limited to a laparoscopy model with a primary foulant of blood. Whereas we have observed efficacy against other soilage events including adipose tissue, bile, and the particulate smoke from the tissue application of energy devices, they were not included in this initial animal study, though we are planning relevant readouts in prospective human observational studies. For simplicity, we purposely limited this animal study to a 10 mm, 30 ° endoscope, however, our observations from other testing demonstrate excellent efficacy when using 0 ° and 45 °scopes. We have additionally seen efficacy in all brands of scopes that we have tested, and minimal impact of the relationship of the angle of the lens to the device. The device has been cleared by the FDA.

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