- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02491710
Comparison of an Inexpensive Tablet-based Laparoscopic Box Trainer With a Standard Box Trainer
Training is of great importance in laparoscopy. There are different commercially available trainers which are quite expensive and are used by trainees only inside the hospital.
The aim of this study is to find out whether basic laparoscopic skills training using an inexpensive tablet-based laparoscopic box trainer leads to equal training results (= improvement of skills) compared to practicing with a conventional commercial box trainer. Furthermore, trainee satisfaction with this home-made alternative compared to the standard trainer will be assessed.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medical students of the Medical University of Vienna
Exclusion Criteria:
- Extensive experience with laparoscopic box trainers or laparoscopic surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low-cost box trainer
Trainees in this arm will perform their basic laparoscopic skills training on a low-cost tablet-based box trainer.
|
|
Active Comparator: Standard box trainer
Trainees in this arm will perform their basic laparoscopic skills training on a standard box trainer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fundamentals of Laparoscopy (FLS) manual Skills Score
Time Frame: After completion of training (4-6 weeks)
|
After completion of training (4-6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trainee satisfaction with the two different training devices
Time Frame: After completion of training (4-6 weeks)
|
Satisfaction will be measured using a visual analogue scale (VAS)
|
After completion of training (4-6 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1322/2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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