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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• General Surgery (GS) residents

Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Ganesh Sankaranarayanan, Ph.D.
Ganesh.Sankaranarayanan@UTSouthwestern.edu
214-648-5442
Time Frame
Start Date: 2025-04-23
Estimated Completion Date: 2025-12
Participants
Target number of participants: 20
Treatments
Experimental: 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).
No_intervention: 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.
Sponsors
Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov