Basic Laparoscopic Skills TrainingNCT02491710
Comparison of an Inexpensive Tablet-based Laparoscopic Box Trainer With a Standard Box Trainer
A study testing Training on low-cost box trainer and Training on standard box trainer in people with Basic Laparoscopic Skills Training, run by Medical University of Vienna.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Laparoscopic Skills Training
- What is being tested?
- Training on low-cost box trainer and Training on standard box trainer
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical students of the Medical University of Vienna
Who cannot join
- Extensive experience with laparoscopic box trainers or laparoscopic surgery
About this study
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.
- Conditions
- Basic Laparoscopic Skills Training
- Being tested
- Training on low-cost box trainer, Training on standard box trainer
- Keywords
- Surgical education, Laparoscopy, Laparoscopic suturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on low-cost box trainerDevice
Training on standard box trainerDevice
| Study group | Role | What they receive |
|---|---|---|
| Low-cost box trainer | Experimental | Trainees in this arm will perform their basic laparoscopic skills training on a low-cost tablet-based box trainer. Receives: Device: Training on low-cost box trainer |
| Standard box trainer | Active comparator | Trainees in this arm will perform their basic laparoscopic skills training on a standard box trainer Receives: Device: Training on standard box trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundamentals of Laparoscopy (FLS) manual Skills Score
Measured: After completion of training (4-6 weeks)
Secondary outcomes (1)
Trainee satisfaction with the two different training devices
Satisfaction will be measured using a visual analogue scale (VAS)
Measured: After completion of training (4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basic Laparoscopic Skills TrainingStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heinrich Husslein, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491710
- Sponsor's protocol ID
- 1322/2015
- Status last verified
- Mar 2018
- First submitted
- 27 Jun 2015
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Inexpensive Tablet-based Laparoscopic Box Trainer With a Standard Box Trainer
- ClinicalTrials.gov ID
- NCT02491710
- Acronym / sponsor ID
- 1322/2015
- Conditions
- Basic Laparoscopic Skills Training
- Keywords
- Surgical education, Laparoscopy, Laparoscopic suturing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-cost box trainer | Experimental | Device: Training on low-cost box trainerTrainees in this arm will perform their basic laparoscopic skills training on a low-cost tablet-based box trainer. |
| Standard box trainer | Active comparator | Device: Training on standard box trainerTrainees in this arm will perform their basic laparoscopic skills training on a standard box trainer |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical students of the Medical University of Vienna
Key exclusion criteria (1 listed)
- Extensive experience with laparoscopic box trainers or laparoscopic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training on low-cost box trainer | Device | Low-cost box trainer |
| Training on standard box trainer | Device | Standard box trainer |
Primary outcome
Fundamentals of Laparoscopy (FLS) manual Skills Score
Time frame: After completion of training (4-6 weeks)
1 secondary outcome
Trainee satisfaction with the two different training devices
Time frame: After completion of training (4-6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
Related trials for Basic Laparoscopic Skills Training
Active, not recruiting
Structured Simulation Training for Laparoscopic and Thoracoscopic Skills in Thoracic Surgery Residents
Surgical Education, Simulation-based Training
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Training on low-cost box trainer and Training on standard box trainer in people with Basic Laparoscopic Skills Training, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundamentals of Laparoscopy (FLS) manual Skills Score (time frame: After completion of training (4-6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.