Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator

NCT ID: NCT06974383

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-23
• Study Completion Date: 2025-12-31

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.

Conditions

Predictive Validity of VLaHHS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• General Surgery (GS) residents

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ganesh Sankaranarayanan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ganesh Sankaranarayanan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ganesh Sankaranarayanan, Ph.D.

Role: CONTACT

Ganesh.Sankaranarayanan@UTSouthwestern.edu

214-648-5442

Facility Contacts

Ganesh Sankaranarayanan, Ph.D.

Role: primary

Ganesh.Sankaranarayanan@UTSouthwestern.edu

214-648-5442

Other Identifiers

1R01EB025247-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU-2021-0151

Identifier Type: -

Identifier Source: org_study_id