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Clinical Trial NCT06974383 ((VLaHHS)) for Predictive Validity of VLaHHS is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator ((VLaHHS)) 20 Virtual

Recruiting
Clinical Trial NCT06974383 ((VLaHHS)) is an interventional study for Predictive Validity of VLaHHS that is recruiting. It started on 23 April 2025 with plans to enroll 20 participants. Led by University of Texas Southwestern Medical Center, it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 29 June 2025.
Brief Summary

The goal of this study is to establish the face, content, discriminant and predictive validity of the Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS). The study population includes GS residents. The goal of developing scenarios for the simulator will be accomplished first and establishing the validity of the VLaHHS will be conducted in three phases after that:

  1. Needs assessment survey of current practices in...
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Detailed Description
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 desi...

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Official Title

Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)

Conditions
Predictive Validity of VLaHHS
Other Study IDs
NCT ID Number
NCT06974383
Start Date (Actual)
2025-04-23
Last Update Posted
2025-06-29
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)
GS Residents
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGroup 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.
No InterventionGroup 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 al...Show More
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 errors on the VLaHHS
Dependent measures for learning curve will be assessed by errors on the VLaHHS
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, where a higher value indicates a higher burden. The NASA-TLX total score can be calculated as the average of all dimensions or using weighted scoring.
Baseline (at pre-test)
Skill level in participants as assessed by completion time
Dependent measures for learning curve will be assessed by completion time.
Immediately post test
Skill level in participants assessed by errors on the VLaHHS
Dependent measures for learning curve will be assessed by errors on the VLaHHS
Immediately post 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 0-100, where a higher value indicates a higher burden. The NASA-TLX total score can be calculated as the average of all dimensions or using weighted scoring.
Immediately post test
Skill retention in participants as assessed by completion time
Dependent measures will be assessed by completion time.
2 weeks after post test
Skill retention in participants as assessed by errors on the VLaHHS
Dependent measures will be assessed by errors on the VLaHHS
2 weeks after post test
Skill retention in participants as assessed by NASA-TLX questionnaire
Dependent measures will be assessed by 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 0-100, where a higher value indicates a higher burden. The NASA-TLX total score can be calculated as the average of all dimensions or using weighted scoring.
2 weeks after post test
Transfer of skill in participants as assessed by GOALS
This measure will be assessed using Global Assessment Tools for Intraoperative Laparoscopic Skills (GOALS). It's a 5-item global rating scale that evaluates performance in areas like depth perception, bimanual dexterity, efficiency, tissue handling, and autonomy. Possible scores in each domain will range from 1-5 and total range combining each domain will be 5-25 with higher score indicating better performance.
Immediately post test
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • General Surgery (GS) residents

  • Residents other than GS
  • Participants who are not residents.
University of Texas Southwestern Medical Center logoUniversity of Texas Southwestern Medical Center
National Institute for Biomedical Imaging and Bioengineering (NIBIB) logoNational Institute for Biomedical Imaging and Bioengineering (NIBIB)
Study Responsible Party
Ganesh Sankaranarayanan, Principal Investigator, Associate Professor, University of Texas Southwestern Medical Center
Study Central Contact
Contact: Ganesh Sankaranarayanan, Ph.D., 214-648-5442, [email protected]
1 Study Locations in 1 Countries

Texas

UT Southwestern Medical Center, Dallas, Texas, 75390, United States
Ganesh Sankaranarayanan, Ph.D., Contact, 214-648-5442, [email protected]
Ganesh Sankaranarayanan, Ph.D., Principal Investigator
Recruiting