The "ELITE" model: construct validation of a new training system for natural orifice transluminal endoscopic surgery (NOTES).

BACKGROUND AND STUDY AIMS The ELITE (endoscopic-laparoscopic interdisciplinary training entity) trainer is a new ex vivo model designed to train conventional laparoscopic and endoscopic skills and to perform hybrid interventions. The aim of the present study was to assess its usefulness for natural orifice transluminal endoscopic surgery (NOTES) procedures. MATERIALS AND METHODS A group of 30 participants (eight gastroenterologists, 22 surgeons) ranging from novices to experts completed the following tasks. Via a trans-sigmoidal approach, anchor points in each quadrant in the abdominal cavity had to be reached. Each participant performed five consecutive courses. The time needed to perform the experiment was evaluated. In a second step to assess advanced skill for NOTES in an external face validation, 20 randomly selected individuals performed a cholecystectomy via the same trans-sigmoidal access. RESULTS All participants passed a significant learning curve during the assessment (total time needed: 473.1 +/- 178.5 seconds for first pass vs. 321.9 +/- 182.0 seconds for fifth pass; P = 0.02, Wilcoxon test). There were 15 novices and 15 endoscopy experts. Significant differences were observed for the total time required to perform the respective procedures between these two groups (first pass: 394.3 +/- 176.6 seconds for experts vs. 531.9 +/- 166.7 seconds for novices; P = 0.040, Mann-Whitney test). Furthermore, NOTES cholecystectomies could successfully be simulated. Participants considered the ELITE to represent a useful simulator for NOTES. CONCLUSION The newly developed ELITE trainer is a suitable tool to train NOTES techniques. Experts could reliably be distinguished from novices and a significant progress by training could be demonstrated.