Off-site Training in LaparoscopyNCT02243215
Off-site Training in Laparoscopy
A study testing Access to a portable trainer for laparoscopic skills in people with Off-site Training in Laparoscopy, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The study is a randomized study exploring the difference between off-site vs. on-site training in laparoscopic skills. The study will be performed using fifty surgical trainees from the departments of urology, surgery and gynecology. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Off-site Training in Laparoscopy
- What is being tested?
- Access to a portable trainer for laparoscopic skills
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Jul 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- hey have performed more than 50 laparoscopic procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Off-site vs. On-site Simulation Training in Laparoscopy a Randomized Trial
The study is a randomized study exploring the difference between off-site vs. on-site training in laparoscopic skills. The study will be performed using fifty surgical trainees from the departments of urology, surgery and gynecology. The participants will be recruited, enrolled and randomized during the introductory course in basic laparoscopic techniques held six times annually at Center of Clinical Education(CEKU).
Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual Reality Simulator(VRS). They will practice until they reach a predefined level of proficiency on seven basic modules, the procedure module; "salpingectomy" on the LapSim™ and reach the passing level of 358pts on the Training and Assessment of Basic Laparoscopic Techniques(TABLT) technical test.
Read more
The intervention group will have a portable trainer available to allow training at their convenience, be it at home or at work. The control group will only practice on-site at CEKU and at their local hospital.
Participants will be asked to keep a training log with details of time spend on training and number of training sessions. The training log will contain information on any type practice involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet trainer or training at CEKU. Also time spend in the operation room, assisting or performing laparoscopic surgery will be registered.
To pass the TABLT all participants will book a test session at CEKU for their final test at the end of their training. At the test sessions TABLT test scores will be established on site by the Chief Investigator and afterwards using video recordings of the test. A blinded rater will give scores based on the video recordings and this will be the decisive rating to determine whether the participant has passed the test.
To pass the VRS training an employee at CEKU will monitor a VRS practice session in which proficiency level is reached.
The enrollment of participants is expected to finish June 2015 a data analysis will be performed in July 2015.
- Conditions
- Off-site Training in Laparoscopy
- Being tested
- Access to a portable trainer for laparoscopic skills
- Keywords
- Laparoscopy, Training, Off-site, Box trainer, Virtual Reality Simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to a portable trainer for laparoscopic skillsOther
Also called Laptap(R)
Participants will have a portable trainer available to allow training at their convenience, and will be able practice on-site at Center of Clinical Education and at their local hospital.
| Study group | Role | What they receive |
|---|---|---|
| Offsite training | Experimental | Access to a portable trainer for laparoscopic skills Receives: Other: Access to a portable trainer for laparoscopic skills |
| Onsite training | No intervention | Will be able practice on-site at Center of Clinical Education and at their local hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test.
Measured: 6 months
Trainees use of off-site training in laparoscopic surgery
Qualitative focus group interviews, individual interviews and log-books
Measured: 6 months
Secondary outcomes (6)
Difference in time(mins.) used on training to reach a defined proficiency level(358pts) on the TABLT technical test.
Measured: 6 months
Difference in the number of training sessions used to reach a defined proficiency level(358pts) on the TABLT technical test.
Measured: 6 months
Difference in time(days) to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
Measured: 6 months
Difference in time(mins.) used on training to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
Measured: 6 months
Difference in number of training sessions used to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
Measured: 6 months
Correlation between participants rating of pre-tests and a blinded rater
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Off-site Training in LaparoscopyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Capital Denmark
- Responsible party
- Principal investigator, Ebbe Thinggaard, Zealand University Hospital
- Investigators
- Ebbe Thinggaard, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243215
- Sponsor's protocol ID
- TABLT 2 Offsite
- Other IDs
- REG-68-2014
- Status last verified
- Oct 2015
- First submitted
- 16 Sep 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Korndorffer JR Jr, Bellows CF, Tekian A, Harris IB, Downing SM. Effective home laparoscopic simulation training: a preliminary evaluation of an improved training paradigm. Am J Surg. 2012 Jan;203(1):1-7. doi: 10.1016/j.amjsurg.2011.07.001.
PubMed 22172481Ericsson KA. Deliberate practice and the acquisition and maintenance of expert performance in medicine and related domains. Acad Med. 2004 Oct;79(10 Suppl):S70-81. doi: 10.1097/00001888-200410001-00022. No abstract available.
PubMed 15383395Gallagher AG, Jordan-Black JA, O'Sullivan GC. Prospective, randomized assessment of the acquisition, maintenance, and loss of laparoscopic skills. Ann Surg. 2012 Aug;256(2):387-93. doi: 10.1097/SLA.0b013e318251f3d2.
PubMed 22580935Strandbygaard J, Bjerrum F, Maagaard M, Winkel P, Larsen CR, Ringsted C, Gluud C, Grantcharov T, Ottesen B, Sorensen JL. Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized trial. Ann Surg. 2013 May;257(5):839-44. doi: 10.1097/SLA.0b013e31827eee6e.
PubMed 23295321Snyder CW, Vandromme MJ, Tyra SL, Hawn MT. Proficiency-based laparoscopic and endoscopic training with virtual reality simulators: a comparison of proctored and independent approaches. J Surg Educ. 2009 Jul-Aug;66(4):201-7. doi: 10.1016/j.jsurg.2009.07.007.
PubMed 19896624Kahol K, Leyba MJ, Deka M, Deka V, Mayes S, Smith M, Ferrara JJ, Panchanathan S. Effect of fatigue on psychomotor and cognitive skills. Am J Surg. 2008 Feb;195(2):195-204. doi: 10.1016/j.amjsurg.2007.10.004.
PubMed 18194679Thinggaard E, Bjerrum F, Strandbygaard J, Konge L, Gogenur I. A randomised clinical trial of take-home laparoscopic training. Dan Med J. 2019 Jan;66(1):A5525.
PubMed 30573006
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Off-site vs. On-site Simulation Training in Laparoscopy a Randomized Trial
- ClinicalTrials.gov ID
- NCT02243215
- Acronym / sponsor ID
- TABLT 2 Offsite
- Conditions
- Off-site Training in Laparoscopy
- Keywords
- Laparoscopy, Training, Off-site, Box trainer, Virtual Reality Simulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Region Capital Denmark
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Sep 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.
The study is a randomized study exploring the difference between off-site vs. on-site training in laparoscopic skills. The study will be performed using fifty surgical trainees from the departments of urology, surgery and gynecology. The participants will be recruited, enrolled and randomized during the introductory course in basic laparoscopic techniques held six times annually at Center of Clinical Education(CEKU).
Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual Reality Simulator(VRS). They will practice until they reach a predefined level of proficiency on seven basic modules, the procedure module; "salpingectomy" on the LapSim™ and reach the passing level of 358pts on the Training and Assessment of Basic Laparoscopic Techniques(TABLT) technical test.
The intervention group will have a portable trainer available to allow training at their convenience, be it at home or at work. The control group will only practice on-site at CEKU and at their local hospital.
Participants will be asked to keep a training log with details of time spend on training and number of training sessions. The training log will contain information on any type practice involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet trainer or training at CEKU. Also time spend in the operation room, assisting or performing laparoscopic surgery will be registered.
To pass the TABLT all participants will book a test session at CEKU for their final test at the end of their training. At the test sessions TABLT test scores will be established on site by the Chief Investigator and afterwards using video recordings of the test. A blinded rater will give scores based on the video recordings and this will be the decisive rating to determine whether the participant has passed the test.
To pass the VRS training an employee at CEKU will monitor a VRS practice session in which proficiency level is reached.
The enrollment of participants is expected to finish June 2015 a data analysis will be performed in July 2015.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Offsite training | Experimental | Other: Access to a portable trainer for laparoscopic skillsAccess to a portable trainer for laparoscopic skills |
| Onsite training | No intervention | –Will be able practice on-site at Center of Clinical Education and at their local hospital. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (1 listed)
- hey have performed more than 50 laparoscopic procedures.
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 |
|---|---|---|
| Access to a portable trainer for laparoscopic skillsAlso: Laptap(R)Participants will have a portable trainer available to allow training at their convenience, and will be able practice on-site at Center of Clinical Education and at their local hospital. | Other | Offsite training |
Primary outcome
Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test.
Time frame: 6 months
Trainees use of off-site training in laparoscopic surgery
Time frame: 6 months
Qualitative focus group interviews, individual interviews and log-books
6 secondary outcomes
Difference in time(mins.) used on training to reach a defined proficiency level(358pts) on the TABLT technical test.
Time frame: 6 months
Difference in the number of training sessions used to reach a defined proficiency level(358pts) on the TABLT technical test.
Time frame: 6 months
Difference in time(days) to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
Time frame: 6 months
Difference in time(mins.) used on training to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
Time frame: 6 months
Difference in number of training sessions used to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
Time frame: 6 months
Correlation between participants rating of pre-tests and a blinded rater
Time frame: 6 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 20 Oct 2015.
- Background: PubMed 22172481Korndorffer JR Jr, Bellows CF, Tekian A, Harris IB, Downing SM. Effective home laparoscopic simulation training: a preliminary evaluation of an improved training paradigm. Am J Surg. 2012 Jan;203(1):1-7. doi: 10.1016/j.amjsurg.2011.07.001.
- Background: PubMed 15383395Ericsson KA. Deliberate practice and the acquisition and maintenance of expert performance in medicine and related domains. Acad Med. 2004 Oct;79(10 Suppl):S70-81. doi: 10.1097/00001888-200410001-00022. No abstract available.
- Background: PubMed 22580935Gallagher AG, Jordan-Black JA, O'Sullivan GC. Prospective, randomized assessment of the acquisition, maintenance, and loss of laparoscopic skills. Ann Surg. 2012 Aug;256(2):387-93. doi: 10.1097/SLA.0b013e318251f3d2.
- Background: PubMed 23295321Strandbygaard J, Bjerrum F, Maagaard M, Winkel P, Larsen CR, Ringsted C, Gluud C, Grantcharov T, Ottesen B, Sorensen JL. Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized trial. Ann Surg. 2013 May;257(5):839-44. doi: 10.1097/SLA.0b013e31827eee6e.
- Background: PubMed 19896624Snyder CW, Vandromme MJ, Tyra SL, Hawn MT. Proficiency-based laparoscopic and endoscopic training with virtual reality simulators: a comparison of proctored and independent approaches. J Surg Educ. 2009 Jul-Aug;66(4):201-7. doi: 10.1016/j.jsurg.2009.07.007.
- Background: PubMed 18194679Kahol K, Leyba MJ, Deka M, Deka V, Mayes S, Smith M, Ferrara JJ, Panchanathan S. Effect of fatigue on psychomotor and cognitive skills. Am J Surg. 2008 Feb;195(2):195-204. doi: 10.1016/j.amjsurg.2007.10.004.
- Derived from this study: PubMed 30573006Thinggaard E, Bjerrum F, Strandbygaard J, Konge L, Gogenur I. A randomised clinical trial of take-home laparoscopic training. Dan Med J. 2019 Jan;66(1):A5525.
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.
Ebbe Thinggaard, MD principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to a portable trainer for laparoscopic skills in people with Off-site Training in Laparoscopy, run by Zealand University Hospital 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 1 inclusion and 1 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 20 Oct 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?
Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02243215, which also lists 7 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 20 Oct 2015; AzTrials last refreshed its copy on 28 Oct 2026.