671 The Effect of Supplementary Simulation-Based Procedural Training: The SIMULATE Randomised Controlled Clinical and Educational Trial

Abstract Aim To evaluate whether surgical trainees undergoing additional simulation, compared to conventional training, are able to achieve proficiency sooner with better patient outcomes. Methods This international, multicentre randomised controlled superiority trial recruited urology trainees (n=94) who had performed ≤10 ureterorenoscopy (URS) cases, as a selected index procedure, with no prior simulation experience. Recruits were randomised to simulation-based training or non-simulation-based training groups, the latter of which is the current standard of training. Training sessions were conducted for the simulation arm, utilising an expert-developed multi-modality training curriculum. The primary outcome was the number of procedures required to achieve proficiency, defined as achieving a score of ≥28 on an OSATS scale, on 3 consecutive operations, without complications. Inpatient surgical complications were also recorded. All participants were followed up for 25 procedures or over 18 months. Results A total of 1140 cases were performed by 65 participants where proficiency was achieved in 21 simulation and 18 conventional participants over a median of 8 and 9 procedures, respectively (HR: 1.41 [95% CI 0.72–2.75]). More participants reached proficiency in the simulation arm in flexible ureterorenoscopy, requiring fewer number of procedures (HR 0.89 [95% CI 0.39–2.02]). Significant differences were observed in overall comparison of OSATS scores between groups (mean difference 1.42 [95% CI 0.91–1.92]; p<0.001), with fewer total complications (15 vs 37; p=0.003) and ureteric injuries (3 vs 9; p<0.001) in the simulation group. Conclusions Simulation-based training demonstrated higher overall proficiency and fewer procedures were required to achieve proficiency in the complex form of the index procedure with surgical complications.