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Off-site Training in Laparoscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02243215
Enrollment
46
Registered
2014-09-17
Start date
2014-09-30
Completion date
2015-07-31
Last updated
2015-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Off-site Training in Laparoscopy

Keywords

Laparoscopy, Training, Off-site, Box trainer, Virtual Reality Simulator

Brief 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. 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.

Interventions

OTHERAccess 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.

Sponsors

Region Capital Denmark
CollaboratorOTHER
Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Trainees use of off-site training in laparoscopic surgery6 monthsQualitative focus group interviews, individual interviews and log-books
Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test.6 months

Secondary

MeasureTime frame
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(358pts) on the TABLT technical test.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 rater6 months

Other

MeasureTime frame
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
Difference in test score on the TABLT technical test.6 months
Difference in number of laparoscopic surgeries during the training period, from enrollment to having passed the TABLT test6 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026