Efficacy of goal-directed minimally invasive surgery simulation training with the Lübeck Toolbox-Curriculum prior to first operations on patients: Study protocol for a multi-centre randomized controlled validation trial (NOVICE)

Abstract

Background: Minimally invasive surgery (MIS) procedures require special psychomotoric skills. Learning of these MIS basic skills is often performed in the operating room (OR). This is economically inefficient and could be improved in terms of patient safety. Against the background of this problem, various MIS simulators have been developed to train MIS basic skills outside the OR. Aim of this study is to evaluate to what extent MIS training programs and simulators improve the residents' skills in performing their first MIS procedures on patients.

Method: The current multicentric RCT will be performed with surgical residents without prior active experience in MIS (n = 14). After the participants have completed their first laparoscopic cholecystectomy as baseline evaluation (CHE I), they will be randomized into two groups: 1) The intervention group will perform the Lübeck Toolbox curriculum, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE (CHE II). Changes or improvements in operative performance (between CHE I and CHE II) will be analyzed and evaluated according to the Global Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).

Discussion: The multicentric randomized controlled trial will help to determine the value of MIS training outside the operation room. Proof of effectiveness in practice transfer could be of considerable relevance with regard to an integration of MIS training programs into surgical education.

Keywords: CHE, cholecystectomy; Cholecystectomy; Education; FLS, Fundamentals of Laparoscopic Surgery; GOALS, Global Assessment Tool for Evaluation of Intraoperative Laparoscopic Skills; LTB, Lübeck Toolbox; Laparoscopy; Lübeck Toolbox; MIS, minimally invasive surgery; MISTELS, McGill Inanimate System for Training and Evaluation of Laparoscopic Skills; Minimally invasive surgery; OR, operating room; Simulation; Training; mITT, modified intention-to-treat.

Fig. 1

Flowchart of the study design and the course of the study.

Fig. 2

The Lübeck Toolbox (LTB) curriculum. The curriculum consists of six subsequent exercises, including a) ‘pack your luggage’, b) ‘weaving’, c) ‘Chinese jump rope’, d) ‘Triangle Cut’, e) ‘Hammer Cut’ and e) ‘Suturing’, in which defined target times must be achieved in order to continue with the next exercise. The target times for each exercise were based on a benchmark-study with experts in MIS and are shown in the figure