Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2014-09-30
2015-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Offsite training
Access to a portable trainer for laparoscopic skills
Access to a portable trainer for laparoscopic skills
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.
Onsite training
Will be able practice on-site at Center of Clinical Education and at their local hospital.
No interventions assigned to this group
Interventions
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Access to a portable trainer for laparoscopic skills
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
Yes
Sponsors
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Region Capital Denmark
OTHER
Zealand University Hospital
OTHER
Responsible Party
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Ebbe Thinggaard
Medical Doctor
Principal Investigators
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Ebbe Thinggaard, MD
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital
Locations
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Center for Clinical Education
Copenhagen, Capital Region, Denmark
Countries
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References
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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.
Ericsson 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.
Gallagher 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.
Strandbygaard 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.
Snyder 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.
Kahol 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.
Thinggaard 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.
Other Identifiers
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REG-68-2014
Identifier Type: OTHER
Identifier Source: secondary_id
TABLT 2 Offsite
Identifier Type: -
Identifier Source: org_study_id
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