Minimally Invasive Surgery Basic Skills Clinical Trial
— NOVICEOfficial 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).
| Status | Recruiting |
| Enrollment | 12 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | May 21, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Medical University Center Schleswig-Holstein Campus Lübeck, Department of surgery | Lubeck | Schleswig-Holstein |
| Lead Sponsor | Collaborator |
|---|---|
| University of Schleswig-Holstein |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | sex of participant | sex of participant (male or female) | 8-12 weeks | |
| Other | dominant hand of participant | dominant hand of participant (right or left) | 8-12 weeks | |
| Other | age of participant | age of the participants | 8-12 weeks | |
| Other | correlation with activities and hobbies | in particular playing an instrument, handicrafts and computer games | 8-12 weeks | |
| Other | inter-rater reliability | possible differences and bias between video ratings by calculation | 8-12 weeks | |
| Primary | Global Operative Assessment of Laparoscopic Skill (GOALS)-Score | The GOALS score is an internationally established score for evaluating the MIS skills of a surgeon | end of inclusion of all participants | |
| Secondary | operation time | operation time of CHE I and CHE 2 | 8-12 weeks | |
| Secondary | percentage of the participants operating time in the total time of the CHE | percentage of participants operating time in the total time of the CHE I and CHE II | 8-12 weeks | |
| Secondary | number of takeovers by the specialist assisting the CHE | 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 | 8-12 weeks | |
| Secondary | potential conversion to laparotomy | potential conversion of the MIS CHE to open surgery | 8-12 weeks |