- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03758586
Spatial Skill Training for Robot-assisted Surgery
An Efficient Single-Session Spatial Skill Trainer for Robot-assisted Surgery: A Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Haifa, Israel
- Rambam Health Care Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Surgical Residents with no previous robotic surgery experience.
Exclusion Criteria:
- Non surgical residents.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Study group
Surgical residents undergoing spatial skill training.
|
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.
|
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SHAM_COMPARATOR: Control group
Surgical residents not undergoing spatial skill training.
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Watching a 20-35 minute long power-point presentation regarding the history of robotic surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tissue piercing
Time Frame: up to 2 hours from enrollment
|
Number of times tissue was pierced during suturing
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up to 2 hours from enrollment
|
|
Tissue tearing
Time Frame: up to 2 hours from enrollment
|
Number of times tissue was teared during suturing
|
up to 2 hours from enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
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
- 0602-18-RMB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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