Laparoscopic Simulation TrainingNCT02530099
Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training
A study testing CN-group and Procedure-group in people with Laparoscopic Simulation Training, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Often the less experienced as medical students are charged with the role as camera navigator and assistant during laparoscopic surgery. Camera navigation is generally considered an easy skill, but it requires specific psychomotor and visuospatial skills. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Simulation Training
- What is being tested?
- CN-group and Procedure-group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2015
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medical students on the 4th, 5th or 6th semester, enrolled at The Faculty of Health Science, University of Copenhagen
- Signed informed consent
Who cannot join
- Previous participation in trials involving simulated laparoscopic training.
- Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon or as a surgical assistant).
- No informed consent.
- Does not speak Danish on a conversational level.
About this study
Official title: Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training - a Randomized Controlled Trial Examining Clinical Transfer
Often the less experienced as medical students are charged with the role as camera navigator and assistant during laparoscopic surgery. Camera navigation is generally considered an easy skill, but it requires specific psychomotor and visuospatial skills. Simulation-based training can improve surgical skills, but little is known on how to optimally structure a training program to acquire camera navigation skills. The objective of this trial is to examine if simulation-based laparoscopic camera navigation skills transfer to the operating room after practicing one of two fundamentally different laparoscopic tasks on a simulator. The first group practice a procedure on a virtual reality simulator, the second group practice camera navigation on a virtual reality simulator and the third group receive no training. All participants are tested as camera navigators and assistants during a procedure in the operating room.
- Conditions
- Laparoscopic Simulation Training
- Being tested
- CN-group, Procedure-group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CN-groupProcedure or surgery
Time limited simulation based training on camera navigation tasks on a virtual reality-simulator.
Procedure-groupProcedure or surgery
Time limited simulation based training on laparoscopic procedure on a virtual reality-simulator.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Receive no training. |
| CN-group | Experimental | Receive basic camera navigation training. Receives: Procedure: CN-group |
| Procedure-group | Experimental | Receive training on a laparoscopic procedure. Receives: Procedure: Procedure-group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeons' rating on camera navigation performance during a procedure in the operating room.
Measured: up to 1-3 weeks post training
Secondary outcomes (1)
Score on the intrinsic motivation inventory-scale
An expression of motivation as a surgical assistant and camera navigation after completion of the procedure in the OR
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Simulation TrainingStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Nilsson, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530099
- Sponsor's protocol ID
- CN-Trial
- Status last verified
- Apr 2016
- First submitted
- 18 Aug 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nilsson C, Sorensen JL, Konge L, Westen M, Stadeager M, Ottesen B, Bjerrum F. Simulation-based camera navigation training in laparoscopy-a randomized trial. Surg Endosc. 2017 May;31(5):2131-2139. doi: 10.1007/s00464-016-5210-5. Epub 2016 Oct 21.
PubMed 27770252
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training - a Randomized Controlled Trial Examining Clinical Transfer
- ClinicalTrials.gov ID
- NCT02530099
- Acronym / sponsor ID
- CN-Trial
- Conditions
- Laparoscopic Simulation Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Aug 2015 (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.
Often the less experienced as medical students are charged with the role as camera navigator and assistant during laparoscopic surgery. Camera navigation is generally considered an easy skill, but it requires specific psychomotor and visuospatial skills. Simulation-based training can improve surgical skills, but little is known on how to optimally structure a training program to acquire camera navigation skills. The objective of this trial is to examine if simulation-based laparoscopic camera navigation skills transfer to the operating room after practicing one of two fundamentally different laparoscopic tasks on a simulator. The first group practice a procedure on a virtual reality simulator, the second group practice camera navigation on a virtual reality simulator and the third group receive no training. All participants are tested as camera navigators and assistants during a procedure in the operating room.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Receive no training. |
| CN-group | Experimental | Procedure: CN-groupReceive basic camera navigation training. |
| Procedure-group | Experimental | Procedure: Procedure-groupReceive training on a laparoscopic procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Medical students on the 4th, 5th or 6th semester, enrolled at The Faculty of Health Science, University of Copenhagen
- Signed informed consent
Key exclusion criteria (4 listed)
- Previous participation in trials involving simulated laparoscopic training.
- Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon or as a surgical assistant).
- 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 |
|---|---|---|
| CN-groupTime limited simulation based training on camera navigation tasks on a virtual reality-simulator. | Procedure or surgery | CN-group |
| Procedure-groupTime limited simulation based training on laparoscopic procedure on a virtual reality-simulator. | Procedure or surgery | Procedure-group |
Primary outcome
Surgeons' rating on camera navigation performance during a procedure in the operating room.
Time frame: up to 1-3 weeks post training
1 secondary outcome
Score on the intrinsic motivation inventory-scale
Time frame: 2 months
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 6 Apr 2016.
- Derived from this study: PubMed 27770252Nilsson C, Sorensen JL, Konge L, Westen M, Stadeager M, Ottesen B, Bjerrum F. Simulation-based camera navigation training in laparoscopy-a randomized trial. Surg Endosc. 2017 May;31(5):2131-2139. doi: 10.1007/s00464-016-5210-5. Epub 2016 Oct 21.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CN-group and Procedure-group in people with Laparoscopic Simulation Training, run by Copenhagen University Hospital, Rigshospitalet.
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 2 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 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Surgeons' rating on camera navigation performance during a procedure in the operating room. (time frame: up to 1-3 weeks post training). 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 NCT02530099, which also lists 1 linked publication.
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 6 Apr 2016; AzTrials last refreshed its copy on 30 Oct 2026.