Minimally Invasive Surgery Basic SkillsNOVICENCT03040544
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)
A study testing LTB-Curriculum and Laparoscopic cholecystectomy in people with Minimally Invasive Surgery Basic Skills, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Minimally Invasive Surgery Basic Skills
- What is being tested?
- LTB-Curriculum and Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 22 May 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medical University Center Schleswig-Holstein Campus Lübeck, Department of surgery
Lübeck, Schleswig-Holstein, 23538
Michael Thomaschewski, MD, +491784007135, Michael.Thomaschewski@uksh.de
About this study
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)
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
- Being tested
- LTB-Curriculum, Laparoscopic cholecystectomy
- Keywords
- minimally invasive surgery, video-based trainer, laparoscopic, simulation training, surgical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTB-CurriculumProcedure or surgery
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.
Laparoscopic cholecystectomyProcedure or surgery
Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS
| Study group | Role | What they receive |
|---|---|---|
| LTB-Curriculum | Experimental | 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. Receives: Procedure: LTB-Curriculum; Procedure: Laparoscopic cholecystectomy |
| no LTB-Curriculums | Active comparator | 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. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Operative Assessment of Laparoscopic Skill (GOALS)-Score
The GOALS score is an internationally established score for evaluating the MIS skills of a surgeon
Measured: end of inclusion of all participants
Secondary outcomes (4)
operation time
operation time of CHE I and CHE 2
Measured: 8-12 weeks
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
Measured: 8-12 weeks
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
Measured: 8-12 weeks
potential conversion to laparotomy
potential conversion of the MIS CHE to open surgery
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start22 May 2017
- Primary completion21 May 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Surgery Basic SkillsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Thomschewski, University Hospital Schleswig-Holstein
- Investigators
- Claudia Benecke, MD, Study director, Medical University Center Schleswig-Holstein Campus LübeckTilman Laubert, MD, Study director, Medical University Center Schleswig-Holstein Campus Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040544
- Sponsor's protocol ID
- NOVICE trial
- Acronym
- NOVICE
- Status last verified
- May 2020
- First submitted
- 29 Jan 2017
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03040544
- Acronym / sponsor ID
- NOVICE / NOVICE trial
- Conditions
- Minimally Invasive Surgery Basic Skills
- Keywords
- minimally invasive surgery, video-based trainer, laparoscopic, simulation training, surgical education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 21 May 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTB-Curriculum | Experimental | Procedure: LTB-Curriculum, Procedure: Laparoscopic cholecystectomyFirst 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. |
| no LTB-Curriculums | Active comparator | Procedure: Laparoscopic cholecystectomySecond 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTB-CurriculumThe 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 or surgery | LTB-Curriculum |
| Laparoscopic cholecystectomyPerforming Laparoscopic cholecystectomy by surgical residents without previous experience in MIS | Procedure or surgery | LTB-Curriculum, no LTB-Curriculums |
Primary outcome
Global Operative Assessment of Laparoscopic Skill (GOALS)-Score
Time frame: end of inclusion of all participants
The GOALS score is an internationally established score for evaluating the MIS skills of a surgeon
4 secondary outcomes
operation time
Time frame: 8-12 weeks
percentage of the participants operating time in the total time of the CHE
Time frame: 8-12 weeks
number of takeovers by the specialist assisting the CHE
Time frame: 8-12 weeks
potential conversion to laparotomy
Time frame: 8-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Benecke, MD study director
Medical University Center Schleswig-Holstein Campus Lübeck
Tilman Laubert, MD study director
Medical University Center Schleswig-Holstein Campus Lübeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTB-Curriculum and Laparoscopic cholecystectomy in people with Minimally Invasive Surgery Basic Skills, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Thomaschewski, MD (+491784007135, Michael.Thomaschewski@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Operative Assessment of Laparoscopic Skill (GOALS)-Score (time frame: end of inclusion of all participants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.