Trial Outcomes & Findings for Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator (NCT NCT06974383)

NCT ID: NCT06974383

Last Updated: 2026-05-19

Results Overview

Dependent measures for learning curve will be assessed by completion time.

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

Baseline (at pre-test)

Results posted on

2026-05-19

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.	Total n=6 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=30 Participants	3 Participants n=30 Participants	6 Participants n=60 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Continuous	30 years n=30 Participants	35 years n=30 Participants	32 years n=60 Participants
Sex: Female, Male Female	1 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants
Sex: Female, Male Male	2 Participants n=30 Participants	3 Participants n=30 Participants	5 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=30 Participants	3 Participants n=30 Participants	5 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Asian	1 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants	2 Participants n=30 Participants	2 Participants n=60 Participants
Race (NIH/OMB) White	2 Participants n=30 Participants	1 Participants n=30 Participants	3 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Region of Enrollment United States	3 Participants n=30 Participants	3 Participants n=30 Participants	6 Participants n=60 Participants

PRIMARY outcome

Timeframe: Baseline (at pre-test)

Dependent measures for learning curve will be assessed by completion time.

Outcome measures

Outcome measures
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.
Skill Level in Participants as Assessed by Completion Time	492.7 Seconds Standard Deviation 306.3	1086.07 Seconds Standard Deviation 410.85

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.
Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS	12 score on a scale Standard Deviation 5.3	13 score on a scale Standard Deviation 5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.
Skill Level in Participants Assessed by NASA-TLX Questionnaire	37 score on a scale Standard Deviation 1.73	32 score on a scale Standard Deviation 3.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.
Skill Level in Participants as Assessed by Completion Time	512.52 Seconds Standard Deviation 113.02	1200.7 Seconds Standard Deviation 211.16

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.
Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS	26.33 score on a scale Standard Deviation 2.88	17 score on a scale Standard Deviation 1.73

PRIMARY outcome

Timeframe: Immediately post test (three weeks after pre-test)

Outcome measures

Outcome measures
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.
Skill Level in Participants Assessed by NASA-TLX Questionnaire	32.66 score on a scale Standard Deviation 8.08	30.66 score on a scale Standard Deviation 7.63

PRIMARY outcome

Timeframe: 2 weeks after post test

Dependent measures will be assessed by completion time of participants on the VLAHHS Crural repair task.

Outcome measures

Outcome measures
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.
Skill Retention in Participants as Assessed by Completion Time	504.38 Seconds Standard Deviation 113.5	648.69 Seconds Standard Deviation 229.97

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.
Skill Level in Participants Assessed by Numerical Performance Scale on the VLaHHS	27.66 score on a scale Standard Deviation 1.52	15.33 score on a scale Standard Deviation 0.57

PRIMARY outcome

Timeframe: 2 weeks after post test

Outcome measures

Outcome measures
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.
Skill Retention in Participants as Assessed by NASA-TLX Questionnaire	31.33 score on a scale Standard Deviation 9.71	31.33 score on a scale Standard Deviation 5.68

PRIMARY outcome

Timeframe: 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: 1. Depth perception (0,3,5) 2. Bimanual dexterity (0,3,5) 3. Efficiency (0,3,5) 4. Tissue handling (0,3,5) 5. Knowledge of procedure (0,3,5) 6. Flow of operation (0,3,5) 7. Instrument handling (0,3,5) 8. Bite size (0,3,5) 9. Knot tying (0,3,5) 10. Needle handling (0,3,5) 11. Crural repair closure (0,3,5) 12. Tissue bites (0,3,5) The total range for the transfer of skills score will be 0-60 with higher score indicating better performance.

Outcome measures

Outcome measures
Measure	Group 1 (Simulation Group) n=3 Participants 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.	Group 2 (Control Group) n=3 Participants 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.
Transfer of Skill in Participants as Assessed by Performance Score	52.66 score on a scale Standard Deviation 3.05	27.5 score on a scale Standard Deviation 18.51

Adverse Events

Group 1 (Simulation Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 (Control Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ganesh Sankaranarayanan

University of Texas Southwestern Medical Center

Phone: 214-648-5442

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place