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Effect of Simulation-based Training on Surgical Proficiency and Patient Outcomes: A Randomised Controlled Clinical and Educational Trial

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SIMULATE Trial Group

Original languageEnglish
JournalEuropean Urology
E-pub ahead of print14 Nov 2021

Bibliographical note

Funding Information: Funding/Support and role of the sponsor: This work was supported by The Urology Foundation, and equipment and instruments for executing the interventional training courses were provided by Olympus, Karl Storz, Boston Scientific, Coloplast, Simbionix, Limbs and Things, and Mediskills. The sponsors played no direct role in the study. Funding Information: Acknowledgments: The authors are grateful to all the contributors listed in Appendix A who were involved in assessment of participants and The Urology Foundation for generously funding this study. The British Association of Urological Surgeons and European Association of Urology Urolithiasis Section are greatly acknowledged for their endorsement and support of the study. Abdullatif Aydın acknowledges the kind support of The London Clinic. Kamran Ahmed and Prokar Dasgupta acknowledge support from the NIHR Biomedical Research Centre, MRC Centre for Transplantation, King’s Health Partners, Guy’s and St. Thomas’ Charity, School of Surgery, Health Education England, Royal College of Surgeons of England, Olympus, The Pelican Group, Technology Strategy Board, and The Vattikuti Foundation. Publisher Copyright: © 2021 European Association of Urology

King's Authors


Background: It is hypothesised that simulation enhances progression along the initial phase of the surgical learning curve. Objective: To evaluate whether residents undergoing additional simulation, compared to conventional training, are able to achieve proficiency sooner with better patient outcomes. Design, setting, and participants: This international, multicentre, randomised controlled trial recruited 94 urology residents with experience of zero to ten procedures and no prior exposure to simulation in ureterorenoscopy, selected as an index procedure. Intervention: Participants were randomised to simulation or conventional operating room training, as is the current standard globally, and followed for 25 procedures or over 18 mo. Outcome measurements and statistical analysis: The number of procedures required to achieve proficiency, defined as achieving a score of ≥28 on the Objective Structured Assessment of Technical Skill (OSATS) scale over three consecutive operations, was measured. Surgical complications were evaluated as a key secondary outcome. This trial is registered at as ISCRTN 12260261. Results and limitations: A total of 1140 cases were performed by 65 participants, with proficiency achieved by 21 simulation and 18 conventional participants over a median of eight and nine procedures, respectively (hazard ratio [HR] 1.41, 95% confidence interval [CI] 0.72–2.75). More participants reached proficiency in the simulation arm in flexible ureterorenoscopy, requiring a lower number of procedures (HR 0.89, 95% CI 0.39–2.02). Significant differences were observed in overall comparison of OSATS scores between the 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: Although the number of procedures required to reach proficiency was similar, simulation-based training led to higher overall proficiency scores than for conventional training. Fewer procedures were required to achieve proficiency in the complex form of the index procedure, with fewer serious complications overall. Patient summary: This study investigated the effect of simulation training in junior surgeons and found that it may improve performance in real operating settings and reduce surgical complications for complex procedures.

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