Clinical trial NCT03040544: 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)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Minimally Invasive Surgery Basic Skills
Keywords: minimally invasive surgery
video-based trainer
laparoscopic
simulation training
surgical education
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* no motor or sensory restrictions when using surgical instruments surgical instruments.
* no previous performed MIS simulation training
* no previous performed MIS procedure ( any previous assisted MIS procedures are not an exclusion criterion)
* residents in surgical education for general or visceral surgery in Germany

Exclusion Criteria:

* The participant are not allowed to perform any other MIS training programs during the study period
* Before the start of the study, participants are not allowed to have performed any prior MIS simulation training or any MIS procedure

Primary outcomes:
measure: Global Operative Assessment of Laparoscopic Skill (GOALS)-Score
timeFrame: end of inclusion of all participants
Secondary outcomes:
measure: operation time
timeFrame: 8-12 weeks
measure: percentage of the participants operating time in the total time of the CHE
timeFrame: 8-12 weeks
measure: number of takeovers by the specialist assisting the CHE
timeFrame: 8-12 weeks
measure: potential conversion to laparotomy
timeFrame: 8-12 weeks
Other outcomes:
measure: sex of participant
timeFrame: 8-12 weeks
measure: dominant hand of participant
timeFrame: 8-12 weeks
measure: age of participant
timeFrame: 8-12 weeks
measure: correlation with activities and hobbies
timeFrame: 8-12 weeks
measure: inter-rater reliability
timeFrame: 8-12 weeks
Locations:
city: Lubeck
country: Germany
facility: Medical University Center Schleswig-Holstein Campus Lübeck, Department of surgery
state: Schleswig-Holstein
Study officials:
affiliation: Medical University Center Schleswig-Holstein Campus Lübeck
name: Claudia Benecke, MD
role: STUDY_DIRECTOR
affiliation: Medical University Center Schleswig-Holstein Campus Lübeck
name: Tilman Laubert, MD
role: STUDY_DIRECTOR
References: