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)

U

University Hospital Schleswig-Holstein (UKSH)

Status

Unknown

Conditions

Minimally Invasive Surgery Basic Skills

Treatments

Procedure: LTB-Curriculum
Procedure: Laparoscopic cholecystectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03040544
NOVICE trial

Details and patient eligibility

About

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).

Enrollment

12 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

12 participants in 2 patient groups

LTB-Curriculum
Experimental group
Description:
First group/arm undergo MIS training according to the LTB curriculum after the first own laparoscopic cholecystectomy in the OR as a baseline. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using the Global Operational Assessment of Laparoscopic Skill (GOALS) score.
Treatment:
Procedure: Laparoscopic cholecystectomy
Procedure: LTB-Curriculum
no LTB-Curriculums
Active Comparator group
Description:
Second group/arm will not undergo any MIS trains after their first laparoscopic CHE in the OR. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using GOALS score.
Treatment:
Procedure: Laparoscopic cholecystectomy

Trial contacts and locations

0

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Central trial contact

Michael Thomaschewski, MD

Data sourced from clinicaltrials.gov

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