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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01EB025247-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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Part 3 Phase III of this protocol is the interventional portion and is the reason why only this Part is registered and reported within this record. The goal of this phase of the study is to establish the learning curve and predictive validity of the VLaHHS. The study population includes GS residents.
The hypothesis is that the subject trained in VLaHHS will improve their skills compared to control with no training and show better transfer of skills on to an actual procedure.
The learning curve of VLaHHS will be established by training subjects in the task over extended period until they reach a plateau. The predictive validity will be established by comparing the training group with a control group with no training by testing their skills on a simulated surgical task using a crural repair silicone model and porcine fundoplication model.
The experimental design is a between-subjects design with two groups to which participants will be randomly assigned: (1) Group 1 (Simulation Group): training with VLaHHS, (2) Group 2 (Control Group): no training. The Crural closure tasks of VLaHHS will be tested (10 subjects per task). Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). For the training phase, participants in Group 1 will perform the tasks on VLaHHS for an hour a day for a maximum of no more than three weeks (3 weeks' x 5 days = 15 sessions). In each session of no more than an hour, subjects will repeat the task five times.
Participants in Group 2 will continue with their normal residency training but will not participate in VLaHHS training at all.
Two aspects of learning will then be assessed post-training: skill learning and transfer-of-training. For the Simulation Group, skill learning will be measured immediately following training (post-test) and again after two weeks to measure retention. For the Control Group, skill learning will be measured four weeks after orientation and again two weeks later to measure retention. Finally, immediately after post-test, transfer-of-training will be assessed using simulated crural repair or fundoplication model. The transfer study will be conducted either at the UT Southwestern (UTSW) Simulation Center or at the Artificial Intelligence and Medical Simulation (AIMS) Lab in south campus.
Dependent measures for learning curve and retention will be the score computed from completion time and errors on the VLaHHS and the workload assessment measured using the NASA-TLX (Task Load Index) questionnaire after each session. For the transfer task, Subjects performance on the crural repair task will be video recorded and evaluated by a minimum of three experts using Global Assessment Tools for Intraoperative Laparoscopic Skills (GOALS) subjective evaluation method.
The videotaping will focus only on subjects hand and any Identifying information such as subjects face will not be captured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Simulation Group) | Experimental | Training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). |
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| Group 2 (Control Group) | No Intervention | No training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). They will continue with their normal residency training but will not participate in VLaHHS training at all. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) | Other | For the training phase, participants in Group 1 will perform the tasks on VLaHHS for an hour a day for a maximum of 15 sessions over 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Skill Level in Participants as Assessed by Completion Time | Dependent measures for learning curve will be assessed by completion time. | Baseline (at pre-test) |
| Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS | Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis:
The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance. | Baseline (at pre-test) |
| Skill Level in Participants Assessed by NASA-TLX Questionnaire | Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden. | Baseline (at pre-test) |
| Skill Level in Participants as Assessed by Completion Time | Dependent measures for learning curve will be assessed by completion time of the participants on the VLAHHS Crural Repair task. | Immediately post test (three weeks after pre-test) |
| Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ganesh Sankaranarayanan, Ph.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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Part 3 Phase III of this protocol is the interventional portion and is the reason why only this Part is registered and reported within this record. 2 subjects didn't complete screening
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (Simulation Group) | Training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS): For the training phase, participants in Group 1 will perform the tasks on VLaHHS for an hour a day for a maximum of 15 sessions over 3 weeks. |
| FG001 | Group 2 (Control Group) | No training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). They will continue with their normal residency training but will not participate in VLaHHS training at all. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Simulation Group) | Training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS): For the training phase, participants in Group 1 will perform the tasks on VLaHHS for an hour a day for a maximum of 15 sessions over 3 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Skill Level in Participants as Assessed by Completion Time | Dependent measures for learning curve will be assessed by completion time. | Posted | Mean | Standard Deviation | Seconds | Baseline (at pre-test) |
|
5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 (Simulation Group) | Training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS): For the training phase, participants in Group 1 will perform the tasks on VLaHHS for an hour a day for a maximum of 15 sessions over 3 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ganesh Sankaranarayanan | University of Texas Southwestern Medical Center | 214-648-5442 | Ganesh.Sankaranarayanan@UTSouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2025 | Nov 26, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 22, 2025 | Nov 26, 2025 | ICF_001.pdf |
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Participants will be randomly assigned to 2 groups - simulation group & Control group
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Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis,
The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance. |
| Immediately post test (three weeks after pre-test) |
| Skill Level in Participants Assessed by NASA-TLX Questionnaire | Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden. | Immediately post test (three weeks after pre-test) |
| Skill Retention in Participants as Assessed by Completion Time | Dependent measures will be assessed by completion time of participants on the VLAHHS Crural repair task. | 2 weeks after post test |
| Skill Level in Participants Assessed by Numerical Performance Scale on the VLaHHS | Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis,
The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance. | 2 weeks after post test |
| Skill Retention in Participants as Assessed by NASA-TLX Questionnaire | Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden. | 2 weeks after post test |
| Transfer of Skill in Participants as Assessed by Performance Score | This measure will be assessed using a performance score assessed using a modified tool that consists of Global Assessment Tools for Intraoperative Laparoscopic Skills (GOALS) domains and task-specific metrics. The individual assessment items and their possible scores are:
The total range for the transfer of skills score will be 0-60 with higher score indicating better performance. | Immediately post test (three weeks after pre-test) |
| BG001 | Group 2 (Control Group) | No training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). They will continue with their normal residency training but will not participate in VLaHHS training at all. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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No training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). They will continue with their normal residency training but will not participate in VLaHHS training at all. |
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| Primary | Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS | Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis:
The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance. | Posted | Mean | Standard Deviation | score on a scale | Baseline (at pre-test) |
|
|
|
| Primary | Skill Level in Participants Assessed by NASA-TLX Questionnaire | Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden. | Posted | Mean | Standard Deviation | score on a scale | Baseline (at pre-test) |
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| Primary | Skill Level in Participants as Assessed by Completion Time | Dependent measures for learning curve will be assessed by completion time of the participants on the VLAHHS Crural Repair task. | Posted | Mean | Standard Deviation | Seconds | Immediately post test (three weeks after pre-test) |
|
|
|
| Primary | Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS | Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis,
The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance. | Posted | Mean | Standard Deviation | score on a scale | Immediately post test (three weeks after pre-test) |
|
|
|
| Primary | Skill Level in Participants Assessed by NASA-TLX Questionnaire | Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden. | Posted | Mean | Standard Deviation | score on a scale | Immediately post test (three weeks after pre-test) |
|
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| Primary | Skill Retention in Participants as Assessed by Completion Time | Dependent measures will be assessed by completion time of participants on the VLAHHS Crural repair task. | Posted | Mean | Standard Deviation | Seconds | 2 weeks after post test |
|
|
|
| Primary | Skill Level in Participants Assessed by Numerical Performance Scale on the VLaHHS | Dependent measures for learning curve will be assessed by numerical score computed based on performance on the VLaHHS. The performance was assessed based on the following metrics with possible scores in parenthesis,
The final numerical score is the sum of all individual performance measures which can range from a minimum of 0 to a maximum of 45. Higher score denotes better performance. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks after post test |
|
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| Primary | Skill Retention in Participants as Assessed by NASA-TLX Questionnaire | Dependent measures for learning curve will be measured using the NASA-TLX questionnaire. The NASA Task Load Index (NASA-TLX) is a tool to subjectively assess cognitive and emotional load during a simulation. Students rate six dimensions: mental and physical demands, time pressure, performance, effort, and frustration. Each dimension is assessed on a scale of 0-10, with a possible total score range of 0 to 60. A higher value indicates a higher burden. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks after post test |
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| Primary | Transfer of Skill in Participants as Assessed by Performance Score | This measure will be assessed using a performance score assessed using a modified tool that consists of Global Assessment Tools for Intraoperative Laparoscopic Skills (GOALS) domains and task-specific metrics. The individual assessment items and their possible scores are:
The total range for the transfer of skills score will be 0-60 with higher score indicating better performance. | Posted | Median | Standard Deviation | score on a scale | Immediately post test (three weeks after pre-test) |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Group 2 (Control Group) | No training with VLaHHS. Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). They will continue with their normal residency training but will not participate in VLaHHS training at all. | 0 | 3 | 0 | 3 | 0 | 3 |
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