Off-site Training in Laparoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Off-site vs. On-site Simulation Training in Laparoscopy a Randomized Trial

Conditions
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Off-site Training in Laparoscopy

Intervention / Treatment
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* Other: Access to a portable trainer for laparoscopic skills


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: hey have performed more than 50 laparoscopic procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Offsite training<br>Access to a portable trainer for laparoscopic skills | Other: Access to a portable trainer for laparoscopic skills<br>* 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.<br>* Other names: Laptap(R);|
| No Intervention: Onsite training<br>Will be able practice on-site at Center of Clinical Education and at their local hospital. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test. |  | 6 months | 
| Trainees use of off-site training in laparoscopic surgery | Qualitative focus group interviews, individual interviews and log-books | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in time(mins.) used on training to reach a defined proficiency level(358pts) on the TABLT technical test. |  | 6 months | 
| Difference in the number of training sessions used to reach a defined proficiency level(358pts) on the TABLT technical test. |  | 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). |  | 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). |  | 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). |  | 6 months | 
| Correlation between participants rating of pre-tests and a blinded rater |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Training, Off-site, Box trainer, Virtual Reality Simulator