Clinical trial NCT06974383: Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator
Official title: Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Predictive Validity of VLaHHS
Keywords: Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)
GS Residents
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2025-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to 2 groups - simulation group \& Control group
Primary purpose: OTHER

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 laparoscopic hiatal hernia repair

a. Development of scenarios and metrics for the VLaHHS b. Assessment of validity of metrics developed for VLaHHS

3) Assessment of validity of VLaHHS

1. Phase I - Face and content Validity Assessment of VLaHHS
2. Phase II - Discriminant Validity Assessment of VLaHHS
3. Phase III - Learning Curve, Retention and Transfer Assessment (predictive validity) of VLaHHS

Part 3- Phase III of this study is the interventional portion while rest of the parts and phases do not involve an intervention. The goal of this phase of the study is to establish the learning curve and predictive validity of the VLaHHS.

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.

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 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. Two separate tasks ((1) Crural closure and (2) Fundoplication ) of VLaHHS will be tested separately (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 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 questionnaire after each session. For the transfer task, Subjects performance on the crural repair and fundoplication 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 (See Appendix AIII).

The videotaping will focus only on subjects hand and any Identifying information such as subjects face will not be captured.

Eligibility criteria: Inclusion Criteria:

* General Surgery (GS) residents

Exclusion Criteria:

* Residents other than GS
* Participants who are not residents.

Primary outcomes:
measure: Skill level in participants as assessed by completion time
timeFrame: Baseline (at pre-test)
measure: Skill level in participants assessed by errors on the VLaHHS
timeFrame: Baseline (at pre-test)
measure: Skill level in participants assessed by NASA-TLX questionnaire
timeFrame: Baseline (at pre-test)
measure: Skill level in participants as assessed by completion time
timeFrame: Immediately post test
measure: Skill level in participants assessed by errors on the VLaHHS
timeFrame: Immediately post test
measure: Skill level in participants assessed by NASA-TLX questionnaire
timeFrame: Immediately post test
measure: Skill retention in participants as assessed by completion time
timeFrame: 2 weeks after post test
measure: Skill retention in participants as assessed by errors on the VLaHHS
timeFrame: 2 weeks after post test
measure: Skill retention in participants as assessed by NASA-TLX questionnaire
timeFrame: 2 weeks after post test
measure: Transfer of skill in participants as assessed by GOALS
timeFrame: Immediately post test
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Ganesh Sankaranarayanan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: