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

Background and study aims What distinguishes endoscopic submucosal dissection (ESD) from endoscopic mucosal resection is the need for three foot pedals to activate the 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: a control group with the three pedals free and the IPEFIX group in which 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 A total of 107 ESDs were performed by eight experts in five 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 times to 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 were 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. Conclusions IPEFIX is a simple device to connect different pedals during endoscopic procedures. It helps to reduce the numbers of foot mistakes during ESD and improves operator comfort.