SurgeryNCT02069951
Procedure-to-procedure Transfer Trial
A study testing Practice a procedural module on a simulator in people with Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Surgical training programs using virtual reality simulators often only use basic skills training and the use of procedural training is very limited. Procedural training differs from basic skills training by requiring integration of isolated skills and decision making and planning components. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Practice a procedural module on a simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Sep 2014
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical students enrolled at The Faculty of Health Science, University of Copenhagen.
- Obtained the bachelor degree in medicine.
- Signed informed consent.
Who cannot join
- Previous participation in trials involving laparoscopic training.
- Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
- No informed consent.
- Does not speak Danish on a conversational level.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Educational Trial of Practicing One Versus Two Laparoscopic Procedural Modules in Simulator Training for Novices on Procedure-to-procedure Transferability
Surgical training programs using virtual reality simulators often only use basic skills training and the use of procedural training is very limited. Procedural training differs from basic skills training by requiring integration of isolated skills and decision making and planning components. However, it is unknown if it is necessary to practice all procedures before operating on actual patients or whether it is simply a matter of learning psychomotor skills and if these skills are transferable between different tasks.
The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it easier to reach proficiency on a different laparoscopic procedure on the simulator because participants have already practiced the integration of isolated skills.
- Conditions
- Surgery
- Being tested
- Practice a procedural module on a simulator
- Keywords
- Laparoscopy, Training, Simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice a procedural module on a simulatorOther
| Study group | Role | What they receive |
|---|---|---|
| Practice two procedures on a simulator | Experimental | All participants start by practicing a series of six basic skills modules until they reach a predefined proficiency level for each module. For all of the basic skills exercises proficiency is reached when the participants have passed the proficiency level for all exercises.
Participants randomised to the intervention group will practice two procedures on a simulator. First a procedural module A (a laparoscopic appendectomy) to a predefined proficiency level. Upon reaching proficiency for procedural module A the participants will practice procedural module B (a laparoscopic salpingectomy) to a predefined proficiency level. Receives: Other: Practice a procedural module on a simulator |
| Practice one procedure on a simulator | No intervention | All participants start by practicing a series of six basic skills modules until they reach a predefined proficiency level for each module. For all of the basic skills exercises proficiency is reached when the participants have passed the proficiency level for all exercises. Each exercise has to be passed twice within five consecutive attempts. Participants randomised to the control group will practice procedural module B (a laparoscopic salpingectomy) to a predefined proficiency level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of repetitions needed to reach a predefined proficiency level for a procedural module on a simulator
The number of repetitions needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.
Measured: Up to 26 weeks
Secondary outcomes (1)
The effective training time on the simulator (minutes) needed to reach the predefined proficiency level for a procedural module.
The effective training time on the simulator (minutes) needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Responsible party
- Principal investigator, Flemming Bjerrum, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Flemming Bjerrum, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069951
- Sponsor's protocol ID
- 102169
- Status last verified
- May 2015
- First submitted
- 20 Feb 2014
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjerrum F, Sorensen JL, Konge L, Rosthoj S, Lindschou J, Ottesen B, Strandbygaard J. Randomized trial to examine procedure-to-procedure transfer in laparoscopic simulator training. Br J Surg. 2016 Jan;103(1):44-50. doi: 10.1002/bjs.9966. Epub 2015 Oct 29.
PubMed 26511775Bjerrum F, Sorensen JL, Konge L, Lindschou J, Rosthoj S, Ottesen B, Strandbygaard J. Procedural specificity in laparoscopic simulator training: protocol for a randomised educational superiority trial. BMC Med Educ. 2014 Oct 10;14:215. doi: 10.1186/1472-6920-14-215.
PubMed 25304939
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Educational Trial of Practicing One Versus Two Laparoscopic Procedural Modules in Simulator Training for Novices on Procedure-to-procedure Transferability
- ClinicalTrials.gov ID
- NCT02069951
- Acronym / sponsor ID
- 102169
- Conditions
- Surgery
- Keywords
- Laparoscopy, Training, Simulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Feb 2014 (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.
Surgical training programs using virtual reality simulators often only use basic skills training and the use of procedural training is very limited. Procedural training differs from basic skills training by requiring integration of isolated skills and decision making and planning components. However, it is unknown if it is necessary to practice all procedures before operating on actual patients or whether it is simply a matter of learning psychomotor skills and if these skills are transferable between different tasks.
The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it easier to reach proficiency on a different laparoscopic procedure on the simulator because participants have already practiced the integration of isolated skills.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Practice two procedures on a simulator | Experimental | Other: Practice a procedural module on a simulatorAll participants start by practicing a series of six basic skills modules until they reach a predefined proficiency level for each module. For all of the basic skills exercises proficiency is reached when the participants have passed the proficiency level for all exercises. Participants randomised to the intervention group will practice two procedures on a simulator. First a procedural module A (a laparoscopic appendectomy) to a predefined proficiency level. Upon reaching proficiency for procedural module A the participants will practice procedural module B (a laparoscopic salpingectomy) to a predefined proficiency level. |
| Practice one procedure on a simulator | No intervention | –All participants start by practicing a series of six basic skills modules until they reach a predefined proficiency level for each module. For all of the basic skills exercises proficiency is reached when the participants have passed the proficiency level for all exercises. Each exercise has to be passed twice within five consecutive attempts. Participants randomised to the control group will practice procedural module B (a laparoscopic salpingectomy) to a predefined proficiency level. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical students enrolled at The Faculty of Health Science, University of Copenhagen.
- Obtained the bachelor degree in medicine.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Previous participation in trials involving laparoscopic training.
- Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
- No informed consent.
- Does not speak Danish on a conversational level.
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 |
|---|---|---|
| Practice a procedural module on a simulator | Other | Practice two procedures on a simulator |
Primary outcome
The number of repetitions needed to reach a predefined proficiency level for a procedural module on a simulator
Time frame: Up to 26 weeks
The number of repetitions needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.
1 secondary outcome
The effective training time on the simulator (minutes) needed to reach the predefined proficiency level for a procedural module.
Time frame: Up to 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Derived from this study: PubMed 26511775Bjerrum F, Sorensen JL, Konge L, Rosthoj S, Lindschou J, Ottesen B, Strandbygaard J. Randomized trial to examine procedure-to-procedure transfer in laparoscopic simulator training. Br J Surg. 2016 Jan;103(1):44-50. doi: 10.1002/bjs.9966. Epub 2015 Oct 29.
- Derived from this study: PubMed 25304939Bjerrum F, Sorensen JL, Konge L, Lindschou J, Rosthoj S, Ottesen B, Strandbygaard J. Procedural specificity in laparoscopic simulator training: protocol for a randomised educational superiority trial. BMC Med Educ. 2014 Oct 10;14:215. doi: 10.1186/1472-6920-14-215.
- JMC Simulation UnitLink provided by the sponsor.
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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.
Flemming Bjerrum, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice a procedural module on a simulator in people with Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 May 2015. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of repetitions needed to reach a predefined proficiency level for a procedural module on a simulator (time frame: Up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02069951, which also lists 2 linked publications.
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 12 May 2015.