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400+ Validation Studies

Evidence-based Simulation Training

Find here a selection of validation studies, the culmination of extensive research and rigorous validation processes providing evidence of the validity and reliability of our simulation technology, which helped pave the way for revolutionizing surgical education and training. Based on some of the studies we have established proficiency-based curricula which are integrated into our simulators.



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Differences between gynecologists and medical residents in basic motor skills of an exercise module of a virtual simulation system Freyre-Santiago JM. Ginecol Obstet Mex, July 2022
OBJECTIVE: To evaluate the differences in the outcomes of the exercises of the basic motor skills module of the Simbionix LAP Mentor simulator between a group of gyne- cology residents and another group of already graduated specialists.
MATERIALS AND METHODS: Observational, prospective, longitudinal and compara- tive study carried out from December 2019 to January 2020 at the Hospital Español de México. Gynecology residents and specialists in the same branch with diverse experience in laparoscopic surgery were selected. The exercises of the basic motor skills module of a virtual reality system were evaluated with a high-fidelity simulation training program. The Student’s t test was applied for variables with normal distribution and the Mann-Whitney U test for variables that did not meet the normality criterion.
RESULTS: Thirty-one participants were included: the specialist group (n = 19) and the resident group (n = 12). Significant differences between residents and specialists were found in exercise 3-eye-hand coordination (4.45 sec, 95%CI: 0.167-8.73; p < 0.05) and in exercise 5-pulling and stapling of leaking hoses (29.58 sec, 95%CI: -42.99 -14.00; p < 0.001), in favor of the specialist group. In exercise 7-cutting and exercise 8-fulguration there were no significant differences between one group and the other.
CONCLUSIONS: The Simbionix LAP Mentor virtual reality simulator detects differences between groups of obstetrician-gynecologists with different experience in minimally invasive gynecologic surgery and residents of the specialty.


Laparoscopic Warm-up Exercises Improve Performance of Senior-Level Trainees During Laparoscopic Renal Surgery Lee et al, Journal of Endourology 2012

Background and Purpose: Surgery is a high-stakes “performance.” Yet, unlike athletes or musicians, surgeons do not engage in routine “warm-up” exercises before “performing” in the operating room. We study the impact of a preoperative warm-up exercise routine (POWER) on surgeon performance during laparoscopic surgery.

Materials and Methods: Serving as their own controls, each subject performed two pairs of laparoscopic cases, each pair consisting of one case with POWER (+POWER) and one without (–POWER). Subjects were randomly assigned to +POWER or −POWER for the initial case of each pairing, and all cases were performed ≥1 week apart. POWER consisted of completing an electrocautery skill task on a virtual reality simulator and 15 minutes of laparoscopic suturing and knot tying in a pelvic box trainer. For each case, cognitive, psychomotor, and technical performance data were collected during two different tasks: mobilization of the colon (MC) and intracorporeal suturing and knot tying (iSKT). Statistical analysis was performed using SYSTAT v11.0.

Results: A total of 28 study cases (14+POWER, 14−POWER) were performed by seven different subjects. Cognitive and psychomotor performance (attention, distraction, workload, spatial reasoning, movement smoothness, posture stability) were found to be significantly better in the +POWER group (P≤0.05) and technical performance, as scored by two blinded laparoscopic experts, was found to be better in the +POWER group for MC (P=0.04) but not iSKT (P=0.92). Technical scores demonstrated excellent reliability using our assessment tool (Cronbach ∝=0.88). Subject performance during POWER was also found to correlate with intraoperative performance scores.

Conclusions: Urologic trainees who perform a POWER approximately 1 hour before laparoscopic renal surgery demonstrate improved cognitive, psychomotor, and technical performance.


Development of a structured virtual reality curriculum for laparoscopic appendicectomy Sinitsky et al, The American Journal of Surgery 2019

Background: Laparoscopic appendicectomy (LA) is a common surgical emergency procedure mainly performed by trainees. The aim was to develop a step-wise structured virtual reality (VR) curriculum for LA to allow junior surgeons to hone their skills in a safe and controlled environment.

Methods: A prospective randomized study was designed using a high-fidelity VR simulator. Thirty-five novices and 25 experts participated in the assessment and their performances were compared to assess construct validity. Learning curve analysis was performed.

Results: Five of the psychomotor tasks and all appendicectomy tasks showed construct validity. Learning was demonstrated in the majority of construct-valid tasks. A novel goal-directed VR curriculum for LA was constructed. Conclusions: A step-wise structured VR curriculum for LA is proposed with a framework which includes computer generated metrics and supports deliberate practice, spacing intervals, human instruction/feedback and assessment. Future study should test the feasibility of its implementation and transferability of acquired skill.


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