Background: For many abdominal surgical interventions, laparotomy has gradually been replaced by laparoscopy, with numerous benefits for the patient in terms of post-operative recovery. However, during laparoscopy, the endoscope only provides a single viewpoint to the surgeon, leaving numerous blind spots and opening the way to peri-operative adverse events. Alternative camera systems have been proposed, but many lack the requisite resolution/robustness for use during surgery or cannot provide real-time images. Here, we present the added value of the Enhanced Laparoscopic Vision System (ELViS) which overcomes these limitations and provides a broad view of the surgical field in addition to the usual high-resolution endoscope.
Methods: Experienced laparoscopy surgeons performed several typical procedure steps on a live pig model. The time-to-completion for surgical exercises performed by conventional endoscopy and ELViS-assisted surgery was measured. A debriefing interview following each operating session was conducted by an ergonomist, and a System Usability Scale (SUS) score was determined.
Results: Proof of concept of ELVIS was achieved in an animal model with seven expert surgeons without peroperative adverse events related to the surgical device. No differences were found in time-to-completion. Mean SUS score was 74.7, classifying the usability of the ELViS as "good". During the debriefing interview, surgeons highlighted several situations where the ELViS provided a real advantage (such as during instrument insertion, exploration of the abdominal cavity or for orientation during close work) and also suggested avenues for improvement of the system.
Conclusions: This first test of the ELViS prototype on a live animal model demonstrated its usability and provided promising and useful feedback for further development.
Keywords: Animal model; Distributed laparoscopy; Enhanced visualisation; Phase 0 medical device evaluation; Trocar prototype.