PHP192 - Innovative Medical Device Design Significantly Reduces Surgeon Intra-Procedural Stress Levels (Ipsl)

Abstract

This pilot study was designed to non-invasively measure surgeon perceived and biologically expressed stress levels during two simulated hernia repairs performed in an animal model. One repair was done using traditional suture methods and flat mesh, and the other using new open hernia repair products, ETHICON SECURESTRAP® Open and ETHICON PHYSIOMESH™ Open. Eight surgeons experienced with mechanical and suture fixation performed the two procedures in a randomized order. Outcomes of Interest: Procedure fixation times Surgeon stress level, evaluated using salivary biomarkers (cortisol and amylase) at multiple time points including before, during, and at 5 and 20 minutes post-procedure Task load questionnaire, SURG-TLX, administered to establish perceived stress levels, including the following domains: mental demands, physical demands, temporal demands, task complexity, situational stress and distractions. The median difference in procedure time, task load and change in stress level between the procedures (SECURESTRAP® Open with PHYSIOMESH™ Open minus Suture fixation with PROCEED®) is reported. The median differences in procedure fixation time and overall task load questionnaire score (weighted for task importance as identified by surgeons) were -23.64 (95%CI: -27.15 to -6.58) minutes and -49.5 (95%CI: -114.0 to -16.0) points respectively, favoring procedures performed using PHYSIOMESH™ Open with SECURESTRAP® Open. The median differences in the maximum change from baseline for sAA and salivary cortisol favored the new product combination of PHYSIOMESH™ Open fixated with SECURESTRAP® Open (sAA: -81.02, 97.5% CI: -291.92 to 131.36 U/mL), (cortisol: -0.0275, 97.5%CI: -0.33 to 0.11 ug/dL) . In addition to dramatic time savings, use of these new products was associated with convincing evidence of reduced perceived stress levels. Additionally, salivary hormone levels may provide a valuable objective measure of surgeons’ intraoperative experience. Measurement of IPSL can provide objective measures of reduced surgical stress which has been associated with reduced surgical errors and improved outcomes.