Completed

NCT Number: NCT06974383

Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator

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.

Completed

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Key information

Conditions

Predictive Validity of VLaHHS

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

General Surgery (GS) residents

Exclusion criteria

Residents other than GS
Participants who are not residents.

Treatment and study plan

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.

Primary outcomes

Skill Level in Participants as Assessed by Completion Time

Time frame: Baseline (at pre-test)

Dependent measures for learning curve will be assessed by completion time.
Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS

Time frame: Baseline (at pre-test)
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:
- Created Equidistant Sutures (0,3,5)
- Smooth Tool Handling (0,3,5)
- Respect for Tissue (0, 3, 5)
- Created All Full Thickness Bites (0, 3, 5)
- Performed Correct In-Out Sequence of suturing (0, 3, 5)
- Did Not Collided with Esophagus (0, 3, 5)
- Created Correct Amount of Knots (0, 3, 5)
- Tightened All Knots (0,3,5)
- Correctly Performed Slipknots (0, 3, 5).
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.
Skill Level in Participants Assessed by NASA-TLX Questionnaire

Time frame: Baseline (at pre-test)

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.
Skill Level in Participants as Assessed by Completion Time

Time frame: Immediately post test (three weeks after pre-test)

Dependent measures for learning curve will be assessed by completion time of the participants on the VLAHHS Crural Repair task.
Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS

Time frame: Immediately post test (three weeks after pre-test)
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,
- Created Equidistant Sutures (0,3,5)
- Smooth Tool Handling (0,3,5)
- Respect for Tissue (0, 3, 5)
- Created All Full Thickness Bites (0, 3, 5)
- Performed Correct In-Out Sequence of suturing (0, 3, 5)
- Did Not Collided with Esophagus (0, 3, 5)
- Created Correct Amount of Knots (0, 3, 5)
- Tightened All Knots (0,3,5)
- Correctly Performed Slipknots (0, 3, 5).
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.
Skill Level in Participants Assessed by NASA-TLX Questionnaire

Time frame: Immediately post test (three weeks after pre-test)

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.
Skill Retention in Participants as Assessed by Completion Time

Time frame: 2 weeks after post test

Dependent measures will be assessed by completion time of participants on the VLAHHS Crural repair task.
Skill Level in Participants Assessed by Numerical Performance Scale on the VLaHHS

Time frame: 2 weeks after post test
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,
- Created Equidistant Sutures (0,3,5)
- Smooth Tool Handling (0,3,5)
- Respect for Tissue (0, 3, 5)
- Created All Full Thickness Bites (0, 3, 5)
- Performed Correct In-Out Sequence of suturing (0, 3, 5)
- Did Not Collided with Esophagus (0, 3, 5)
- Created Correct Amount of Knots (0, 3, 5)
- Tightened All Knots (0,3,5)
- Correctly Performed Slipknots (0, 3, 5).
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.
Skill Retention in Participants as Assessed by NASA-TLX Questionnaire

Time frame: 2 weeks after post test

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.
Transfer of Skill in Participants as Assessed by Performance Score

Time frame: Immediately post test (three weeks after pre-test)
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:
- Depth perception (0,3,5)
- Bimanual dexterity (0,3,5)
- Efficiency (0,3,5)
- Tissue handling (0,3,5)
- Knowledge of procedure (0,3,5)
- Flow of operation (0,3,5)
- Instrument handling (0,3,5)
- Bite size (0,3,5)
- Knot tying (0,3,5)
- Needle handling (0,3,5)
- Crural repair closure (0,3,5)
- Tissue bites (0,3,5)
The total range for the transfer of skills score will be 0-60 with higher score indicating better performance.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

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

Acronym: (VLaHHS)

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: May 15, 2025
Registry last updated: May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.