Design and validation of a simulation-based training module for ileo-transverse intracorporeal anastomosis.

Background: The benefits of the totally laparoscopic right hemicolectomy have been established, but its adoption has been limited by the challenges of intracorporeal suturing. While simulation is effective for training advanced surgical skills, no dedicated simulation-based course exists for intracorporeal ileo-transverse anastomosis (ICA). This study aimed to develop and validate a simulation module for training in ICA.

Methods: This study employed a proof-of-concept design for an educational tool. Key aspects of the anastomosis were identified using the team's surgical experience, surgical videos, and existing evidence. Surgeons were recruited to test and refine successive simulation models through an iterative process until a functional prototype was achieved and assessed. Subsequently, surgeons with varying experience levels were invited to perform an ICA in the model. Performance was evaluated by two blinded surgeons through video recordings, utilizing a modified Objective Structured Assessment of Technical Skills (OSATS), a Specific Rating Score (SRS), and operative time measurements. Non-parametric descriptive and analytical methods were applied, with results presented as median [IQR].

Results: An ex vivo based model was developed. Seventeen participants evaluated the model. Eighty-three percent declared acceptable or maximum fidelity regarding the colon. Resemblance to the surgical scenario in terms of ergonomic and anatomical similarity was highlighted. All participants found the model useful to train intracorporeal suturing. Thirteen subjects performed the ICA. Experts achieved significantly higher OSATS scores (22.3 [22-22.5] vs 18 [16-19.5]; p = .013), exhibited a trend toward higher SRS, and obtained shorter operative times (21.5 vs 36 min; p = .039).

Conclusion: An ex vivo simulation module for ICA was developed, demonstrating acceptable fidelity in replicating the surgical environment. The simulated scenario could successfully distinguish between levels of surgical experience, as evidenced by significant differences in OSATS scores and operative times, thereby confirming its construct validity.