Off-site Training in Laparoscopy
- Conditions
- Off-site Training in Laparoscopy
- Interventions
- Other: Access to a portable trainer for laparoscopic skills
- Registration Number
- NCT02243215
- Lead Sponsor
- Zealand University Hospital
- 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 LapSimâ„¢ 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- Participant is willing and able to give informed consent for participation in the study.
- hey have performed more than 50 laparoscopic procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Offsite training Access to a portable trainer for laparoscopic skills Access to a portable trainer for laparoscopic skills
- Primary Outcome Measures
Name Time Method 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 6 months Qualitative focus group interviews, individual interviews and log-books
- Secondary Outcome Measures
Name Time Method 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 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 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 the number of training sessions used to reach a defined proficiency level(358pts) on the TABLT technical test. 6 months
Trial Locations
- Locations (1)
Center for Clinical Education
🇩🇰Copenhagen, Capital Region, Denmark