Spatial LearningNCT03758586
Spatial Skill Training for Robot-assisted Surgery
A study testing Computerized spatial skill training and Watching a presentation regarding robotic surgery in people with Spatial Learning, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Surgical residents from a single tertiary medical center were divided into 2 groups. All residents performed 2 tasks on a Da Vinci robotic simulator system after which they were either given a real training session in spatial skills (study group) or shown a short presentation regarding robotic surgery. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Spatial Learning
- What is being tested?
- Computerized spatial skill training and Watching a presentation regarding robotic surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2017to 1 Jan 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Surgical Residents with no previous robotic surgery experience.
Who cannot join
- Non surgical residents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Efficient Single-Session Spatial Skill Trainer for Robot-assisted Surgery: A Randomized Trial
Surgical residents from a single tertiary medical center were divided into 2 groups. All residents performed 2 tasks on a Da Vinci robotic simulator system after which they were either given a real training session in spatial skills (study group) or shown a short presentation regarding robotic surgery. After training/watching the presentation, they repeated the for mentioned tasks on the robotic simulator. Improvement in surgeon performance, especially regarding tissue damage was documented.
Read the detailed description
Importance: Robot-assisted surgery is becoming the mainstay of modern surgery. Efficient training techniques are essential for enhanced performance. Optimal performance during a surgical task is key to successful surgery and minimal adverse events.
Objective: To introduce and examine a single session of spatial skill training as an efficient means of improving surgical suturing performance in robot-assisted surgery.
Design: Forty-one surgical residents will be randomly assigned to training and control conditions. (1) participants will perform two da-Vinci skills simulator (dVSS) tasks to determine baseline performance. (2) the training group will undergo computer-based simulator training of spatial skills while the control group will engage in a neutral activity. (3) two dVSS tasks will be performed within 2 days of training completion to evaluate post-training performance. The experiment will be conducted until December 2018.
Participants: A convenience sample comprised of 41 surgical residents with non-robotic surgical suturing skills.
- Conditions
- Spatial Learning
- Being tested
- Computerized spatial skill training, Watching a presentation regarding robotic surgery
- Medical subject headings
- Spatial Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized spatial skill trainingOther
The spatial skills training session consisted of six practice trials that were run in a sequence. The objective of each practice was to manipulate the simulated robotic arm to grab the cubes and move them to a desired location using keyboard keys. The participant was required to reach a decision based on the visual-spatial information, before initiating subsequent movements of the simulated robotic arm. Each practice trial presented an initial state of the cubes in front of the robotic arm, and a target position of the cubes.
Watching a presentation regarding robotic surgeryOther
Watching a 20-35 minute long power-point presentation regarding the history of robotic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Surgical residents undergoing spatial skill training. Receives: Other: Computerized spatial skill training |
| Control group | Sham comparator | Surgical residents not undergoing spatial skill training. Receives: Other: Watching a presentation regarding robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue piercing
Number of times tissue was pierced during suturing
Measured: up to 2 hours from enrollment
Tissue tearing
Number of times tissue was teared during suturing
Measured: up to 2 hours from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Jan 2017
- Primary completion1 Sep 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial LearningStudies 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
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758586
- Sponsor's protocol ID
- 0602-18-RMB
- Status last verified
- Nov 2018
- First submitted
- 24 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficient Single-Session Spatial Skill Trainer for Robot-assisted Surgery: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03758586
- Acronym / sponsor ID
- 0602-18-RMB
- Conditions
- Spatial Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 29 Nov 2018 (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.
Surgical residents from a single tertiary medical center were divided into 2 groups. All residents performed 2 tasks on a Da Vinci robotic simulator system after which they were either given a real training session in spatial skills (study group) or shown a short presentation regarding robotic surgery. After training/watching the presentation, they repeated the for mentioned tasks on the robotic simulator. Improvement in surgeon performance, especially regarding tissue damage was documented.
Detailed description
Importance: Robot-assisted surgery is becoming the mainstay of modern surgery. Efficient training techniques are essential for enhanced performance. Optimal performance during a surgical task is key to successful surgery and minimal adverse events.
Objective: To introduce and examine a single session of spatial skill training as an efficient means of improving surgical suturing performance in robot-assisted surgery.
Design: Forty-one surgical residents will be randomly assigned to training and control conditions. (1) participants will perform two da-Vinci skills simulator (dVSS) tasks to determine baseline performance. (2) the training group will undergo computer-based simulator training of spatial skills while the control group will engage in a neutral activity. (3) two dVSS tasks will be performed within 2 days of training completion to evaluate post-training performance. The experiment will be conducted until December 2018.
Participants: A convenience sample comprised of 41 surgical residents with non-robotic surgical suturing skills.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Other: Computerized spatial skill trainingSurgical residents undergoing spatial skill training. |
| Control group | Sham comparator | Other: Watching a presentation regarding robotic surgerySurgical residents not undergoing spatial skill training. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Surgical Residents with no previous robotic surgery experience.
Key exclusion criteria (1 listed)
- Non surgical residents.
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 |
|---|---|---|
| Computerized spatial skill trainingThe spatial skills training session consisted of six practice trials that were run in a sequence. The objective of each practice was to manipulate the simulated robotic arm to grab the cubes and move them to a desired location using keyboard keys. The participant was required to reach a decision based on the visual-spatial information, before initiating subsequent movements of the simulated robotic arm. Each practice trial presented an initial state of the cubes in front of the robotic arm, and a target position of the cubes. | Other | Study group |
| Watching a presentation regarding robotic surgeryWatching a 20-35 minute long power-point presentation regarding the history of robotic surgery. | Other | Control group |
Primary outcome
Tissue piercing
Time frame: up to 2 hours from enrollment
Number of times tissue was pierced during suturing
Tissue tearing
Time frame: up to 2 hours from enrollment
Number of times tissue was teared during suturing
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 29 Nov 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.
Roy Lauterbach, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized spatial skill training and Watching a presentation regarding robotic surgery in people with Spatial Learning, run by Rambam Health Care Campus at 1 site in Israel.
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 29 Nov 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 Israel. 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 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?
Tissue piercing (time frame: up to 2 hours from enrollment). The study lists 2 primary outcomes in all. 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 29 Nov 2018.