Minimally Invasive Surgery Basic Skills Clinical Trial
Official title:
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)
Background: Laparoscopic surgical procedures have become increasingly established in
operative medicine. They require special motor, haptic, and spatial-visual skills to perform
the interventions safely and effectively. These minimally invasive surgery (MIS) basic skills
are often learned in the operating room (OR) on the patient. This is economically inefficient
and can be improved with regard to patient safety. Against the background of this problem,
various simulators and video-box trainer have been developed in order to train laparoscopic
basic skills outside the OR. The Lübecker Toolbox (LTB) curriculum is a video-based trainer
including standardized and validated exercises with defined targets, based on the skills of
experts MIS. Conducting MIS training outside the OR prior to performing the first MIS
procedures on patients could be a sensible and valuable contribution to effective surgical
education. An evidence of effectiveness in the practice transfer could have a considerable
relevance with regard to the integration of MIS training programs into surgical education
programs.
Aim of the study: The aim of the study is to investigate whether surgical residents without
previous active experience in MIS are able to improve laparoscopic skills in MIS procedures
in the OR, if they have successfully completed the LTB curriculum.
In the multicentric prospective study, will be conducted with surgical residents (SR) without
prior active experience in MIS (n=14). After the SR have completed their first laparoscopic
cholecystectomy (CHE), they will be randomized into two groups: 1) The intervention group
will perform the LTB-Curriculum, whereas 2) the control group will not undergo any MIS
training. After 6 weeks, both groups will perform the second laparoscopic CHE. Improvements
in operative performance (between CHE I and CHE II) will be evaluated according to the Global
Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).
n/a