Off-site Training in Laparoscopy Clinical Trial
Official title:
Off-site vs. On-site Simulation Training in Laparoscopy a Randomized Trial
| Verified date | October 2015 |
| Source | Zealand University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Center for Clinical Education | Copenhagen | Capital Region |
| Lead Sponsor | Collaborator |
|---|---|
| Zealand University Hospital | Region Capital Denmark |
Denmark,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Difference in number of laparoscopic surgeries in 6 month period after having passed the TABLT test and reached a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R). | 6 months | ||
| Other | Difference in test score on the TABLT technical test. | 6 months | ||
| Other | Difference in number of laparoscopic surgeries during the training period, from enrollment to having passed the TABLT test | 6 months | ||
| Primary | Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test. | 6 months | ||
| Primary | Trainees use of off-site training in laparoscopic surgery | Qualitative focus group interviews, individual interviews and log-books | 6 months | |
| Secondary | Difference in time(mins.) used on training to reach a defined proficiency level(358pts) on the TABLT technical test. | 6 months | ||
| Secondary | Difference in the number of training sessions used to reach a defined proficiency level(358pts) on the TABLT technical test. | 6 months | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Correlation between participants rating of pre-tests and a blinded rater | 6 months |