Goal-directed MIS Simulation Training With the LTB-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE)

Summary

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).

Conditions

• Minimally Invasive Surgery Basic Skills

Interventions

PROCEDURE

LTB-Curriculum

The Lübeck Toolbox (LTB) curriculum has a structured training program, in which the laparoscopic basic skills are to be learned in six consecutive exercises. In doing so, the curriculum has precise targets for each of the six exercises based on the abilities of 15 MIS experts as a benchmark. The LTB curriculum is thus a structured training program with clear objectives that enable the technical learning of MIS basic skills comparable to the expert level.

PROCEDURE

Laparoscopic cholecystectomy

Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS

Sponsors & Collaborators

• University Hospital Schleswig-Holstein

  lead OTHER

Principal Investigators

• Claudia Benecke, MD · Medical University Center Schleswig-Holstein Campus Lübeck

• Tilman Laubert, MD · Medical University Center Schleswig-Holstein Campus Lübeck

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-05-22

Primary Completion

2020-05-21

Completion

2020-12-31

Countries

• Germany

Study Locations