Laparoscopy TrainingNCT03079908
Comparison of da Vinci Simulator vs LapSim Simulator
A study testing da Vinci Skills Simulator®, LapSim® and Dry lab box laparoscopic training in people with Laparoscopy Training and Robotic Surgery Training, run by Klinik für Allgemein- und Viszeralchirurgie, Department Chirurgie, Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
Virtual reality surgical simulators (VRSS) are gaining popularity for general surgery training, both for conventional laparoscopic and robotically-assisted surgery. Although numerous studies have analysed the impact of VRSS training on surgical skills, there is a lack of data regarding the comparison of robotic VRSS… Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopy Training, Robotic Surgery Training
- What is being tested?
- da Vinci Skills Simulator®, LapSim® and Dry lab box laparoscopic training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Aug 2017to Jun 2018
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy medical students aged 20 to 30 years old
Who cannot join
- No prior surgical, laparoscopic or robotic experience
- No previously known severe learning disability or mental deficiency
- No handicap limiting the usage of one or both upper limb(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the da Vinci Skills Simulator and the LapSim Laparoscopy Simulator for Conventional Laparoscopic Skills Improvement: a Prospective, Randomized Trial
Virtual reality surgical simulators (VRSS) are gaining popularity for general surgery training, both for conventional laparoscopic and robotically-assisted surgery. Although numerous studies have analysed the impact of VRSS training on surgical skills, there is a lack of data regarding the comparison of robotic VRSS (RVRSS) and laparoscopic VRSS (LVRSS) training on conventional laparoscopic skills among subjects with no prior surgical experience. The hypothesis of the present study is that RVRSS could improve conventional laparoscopic skills as much as laparoscopic LVRSS among naïve subjects
- Conditions
- Laparoscopy Training, Robotic Surgery Training
- Being tested
- da Vinci Skills Simulator®, LapSim®, Dry lab box laparoscopic training
- Keywords
- Laparoscopy, Surgery, Training, Virtual reality, Simulation, Robotic Surgery, Da Vinci
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci Skills Simulator®Other
Initial robotic virtual reality surgical simulator Training (da Vinci Skills Simulator ® System), then laparoscopic dry box evaluation
LapSim®Other
Initial laparoscopic virtual reality surgical simulator training (LapSim ® System), then laparoscopic dry box evaluation
Dry lab box laparoscopic trainingOther
No initial simulator training. Dry lab box laparoscopic Training only.
| Study group | Role | What they receive |
|---|---|---|
| Da Vinci Skills Simulator® | Experimental | Participants in this group will undergo robotic virtual reality surgical simulator training (Da Vinci Mimics) and will subsequently be evaluated on a dry lab laparoscopic box Receives: Other: da Vinci Skills Simulator® |
| LapSim® | Active comparator | Participants in this group will undergo laparoscopic virtual reality surgical simulator Training (LapSim) and will subsequently be evaluated on a dry lab laparoscopic box Receives: Other: LapSim® |
| Dry lab box laparoscopic training | Placebo comparator | Participants in this group will undergo dry lab box laparoscopic training only Receives: Other: Dry lab box laparoscopic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercises times
Time to realize each training exercise as well as the final evaluation exercise
Measured: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Secondary outcomes (3)
Objects drops
Number of time objects were unwillingly dropped during each training exercise as well as the final evaluation exercise
Measured: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Objects out of view
Number of times one or both instruments or objects used for the exercises were out of the viewing field during each training exercise as well as the final evaluation exercise
Measured: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Instruments collisions
Number of collisions between the different instruments used to perform each training exercise as well as the final evaluation exercise
Measured: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start15 Aug 2017
- Primary completionNov 2017 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: Not enough resources to start the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopy TrainingStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Allgemein- und Viszeralchirurgie, Department Chirurgie, Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouya Iranmanesh, Klinik für Allgemein- und Viszeralchirurgie, Department Chirurgie, Luzerner Kantonsspital
- Investigators
- Andreas Scheiwiller, MD, Study director, Luzerner Kantonsspital Luzern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079908
- Sponsor's protocol ID
- Simulator study
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2017
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the da Vinci Skills Simulator and the LapSim Laparoscopy Simulator for Conventional Laparoscopic Skills Improvement: a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT03079908
- Acronym / sponsor ID
- Simulator study
- Conditions
- Laparoscopy Training, Robotic Surgery Training
- Keywords
- Laparoscopy, Surgery, Training, Virtual reality, Simulation, Robotic Surgery, Da Vinci
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough resources to start the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Klinik für Allgemein- und Viszeralchirurgie, Department Chirurgie, Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 15 Mar 2017 (actual)
- 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.
Virtual reality surgical simulators (VRSS) are gaining popularity for general surgery training, both for conventional laparoscopic and robotically-assisted surgery. Although numerous studies have analysed the impact of VRSS training on surgical skills, there is a lack of data regarding the comparison of robotic VRSS (RVRSS) and laparoscopic VRSS (LVRSS) training on conventional laparoscopic skills among subjects with no prior surgical experience. The hypothesis of the present study is that RVRSS could improve conventional laparoscopic skills as much as laparoscopic LVRSS among naïve subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Da Vinci Skills Simulator® | Experimental | Other: da Vinci Skills Simulator®Participants in this group will undergo robotic virtual reality surgical simulator training (Da Vinci Mimics) and will subsequently be evaluated on a dry lab laparoscopic box |
| LapSim® | Active comparator | Other: LapSim®Participants in this group will undergo laparoscopic virtual reality surgical simulator Training (LapSim) and will subsequently be evaluated on a dry lab laparoscopic box |
| Dry lab box laparoscopic training | Placebo comparator | Other: Dry lab box laparoscopic trainingParticipants in this group will undergo dry lab box laparoscopic training only |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy medical students aged 20 to 30 years old
Key exclusion criteria (3 listed)
- No prior surgical, laparoscopic or robotic experience
- No previously known severe learning disability or mental deficiency
- No handicap limiting the usage of one or both upper limb(s)
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 |
|---|---|---|
| da Vinci Skills Simulator®Initial robotic virtual reality surgical simulator Training (da Vinci Skills Simulator ® System), then laparoscopic dry box evaluation | Other | Da Vinci Skills Simulator® |
| LapSim®Initial laparoscopic virtual reality surgical simulator training (LapSim ® System), then laparoscopic dry box evaluation | Other | LapSim® |
| Dry lab box laparoscopic trainingNo initial simulator training. Dry lab box laparoscopic Training only. | Other | Dry lab box laparoscopic training |
Primary outcome
Exercises times
Time frame: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Time to realize each training exercise as well as the final evaluation exercise
3 secondary outcomes
Objects drops
Time frame: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Objects out of view
Time frame: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Instruments collisions
Time frame: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Andreas Scheiwiller, MD study director
Luzerner Kantonsspital Luzern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing da Vinci Skills Simulator®, LapSim® and Dry lab box laparoscopic training in people with Laparoscopy Training and Robotic Surgery Training, run by Klinik für Allgemein- und Viszeralchirurgie, Department Chirurgie, Luzerner Kantonsspital at 1 site in Switzerland.
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 3 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: withdrawn, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Exercises times (time frame: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)). 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 13 Mar 2018.