The „ELITE“: Construct validation of a new training system for NOTES

Objectives: The development and penetration of NOTES is severely impaired by the lack of adequate training models. The ELITE trainer (endoscopic-laparoscopicinterdisciplinarytrainingentity) is a new ex-vivo model offering a highly immersive reconstruction of the abdominal cavity to train NOTES techniques. The aim of this study was to evaluate the construct validity of this new simulator, in order to determine its usefulness for training basic NOTES skills.

Methods and Procedures: A pilot group of 30 residents (8 gastroenterologists, 22 surgeons) ranging from novices (< 500 endoscopic procedures and/or < 30 laparoscopic procedures), to experts (< 500 endoscopic procedures and/or > 30 laparoscopic procedures) completed the following tasks: Via a transsigmoidal perforation four anchorpoints in each quadrant in the abdominal cavity had to be reached (symbolizing cardiac region, gallbladder, left ovary and appendix). The parameters studied were task time needed to reach each point and to assess the appropriateness of the ELITE trainer as a teaching model. Each participant had to perform five consecutive courses.

Results: There were 15 novices and 15 experts. Significant differences were observed for the total time required to perform the respective procedures between these two different groups (first pass: 394.3 ± 176.6 sec for experts vs. 531.9 ± 166.7 sec for beginners, p = 0.040, Mann-Whitney-test). All participants passed a significant learning curve during the assessment (total time needed: 473.1 ± 178.5 sec for first pass vs. 321.9 ± 182.0 sec for fifth pass; p = 0.02, Wilcoxon-test). Concerning laparoscopic skills the group consisted of 9 experts and 21 novices. There was no statistical significant difference between these two groups with respect to total time required (p = 0.108; Mann-Whitney-test). NOTES-procedures such as appendectomy and cholecystectomy could be successfully simulated.

The ELITE was considered to represent a useful simulator for NOTES by 29/30 (96.7%) of all participants.

Conclusion: Our newly developed „ELITE“-simulator is a suitable tool to train NOTES techniques. Experts could reliably be distinguished from novices and a significant progress by training could be demonstrated.