Minimally Invasive Surgery Basic Skills
Conditions
Keywords
minimally invasive surgery, video-based trainer, laparoscopic, simulation training, surgical education
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).
Interventions
PROCEDURELTB-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.
PROCEDURELaparoscopic cholecystectomy
Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS
Sponsors
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Operative Assessment of Laparoscopic Skill (GOALS)-Score | end of inclusion of all participants | The GOALS score is an internationally established score for evaluating the MIS skills of a surgeon |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operation time | 8-12 weeks | operation time of CHE I and CHE 2 |
| percentage of the participants operating time in the total time of the CHE | 8-12 weeks | percentage of participants operating time in the total time of the CHE I and CHE II |
| number of takeovers by the specialist assisting the CHE | 8-12 weeks | experienced consultant surgeon will assist the CHE. The specialist can take over the operation at any time and perform surgical steps independently, according to his/her judgement with regard to the individual situation |
| potential conversion to laparotomy | 8-12 weeks | potential conversion of the MIS CHE to open surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| sex of participant | 8-12 weeks | sex of participant (male or female) |
| dominant hand of participant | 8-12 weeks | dominant hand of participant (right or left) |
| age of participant | 8-12 weeks | age of the participants |
| correlation with activities and hobbies | 8-12 weeks | in particular playing an instrument, handicrafts and computer games |
| inter-rater reliability | 8-12 weeks | possible differences and bias between video ratings by calculation |
Countries
Germany
Contacts
Primary ContactMichael Thomaschewski, MD
Outcome results
None listed