A 3D-printed pedal fixator for connecting different pedal-operated tools reduces the number of mistakes during endoscopic submucosal dissection

Abstract Introduction: The particularity of endoscopic submucosal dissection (ESD) compared to endoscopic mucosal resection is the need of three feet pedals to activate electrosurgical unit, flushing and knife injection. The lack of connection between the various pedals of different shapes and brands leads to numerous pedals displacements and potential mistakes. The aim of this study was to evaluate an innovative pedal fixator (IPEFIX) to reduce pedal mistakes during ESD. Methods: This was a prospective, multicenter randomized study. Consecutive ESD procedures were randomly assigned to two groups: control group with the three pedals free and the IPEFIX group where the three pedals were linked by IPEFIX. The main outcome evaluated was the number of foot mistakes (wrong pedal, foot push beside the pedal). Results: 107 ESD were performed by 8 experts in 5 centers. The median number of mistakes per hour of ESD procedure was 0/h in the IPEFIX group and 1.9/h in the control group (p<0.001). The mean number of look down to control the position of the pedals was 2.2/h the IPEFIX group and 7.7/h in the control group (p<0.001). Mean replacements of the pedals was 0./h in the IPEFIX group and 1.7/h in the control group (p<0.001). Similar results were obtained in trainees in simulated ESD on animal models. Conclusion: IPEFIX is a simple device to connect different pedals during endoscopic procedure. It helps to reduce the numbers of foot mistakes during ESD and improve the comfort of the operator