Virtual Laparoscopic Simulator for Hiatal Hernia

((VLaHHS) Trial)

Overseen By Ganesh Sankaranarayanan, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Non-GS residents, Non-residents

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new virtual tool designed to train surgeons in repairing hiatal hernias, which are stomach issues that can cause discomfort and heartburn. The main goal is to determine if practicing with this simulator improves surgical skills more effectively than no additional training. Participants will either use the Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) or continue with their usual training for comparison. This trial suits general surgery residents seeking to enhance their laparoscopic (minimally invasive surgery) skills. As an unphased trial, it offers participants the chance to contribute to innovative educational methods in surgical training.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Virtual Laparoscopic Hiatal Hernia Simulator is safe for use in training?

Research has shown that the Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) is a virtual reality tool that improves surgical skills for treating hiatal hernias. A hiatal hernia occurs when part of the stomach pushes into the chest through a gap in the diaphragm. This simulator, using virtual reality, poses no risk to participants as it is neither a drug nor a surgical procedure. No known side effects exist from using this type of simulator, as it involves no physical procedures or medications. The primary goal is to enhance learning and skill development in a safe, controlled virtual setting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) because it offers a new way to train surgeons in a safe, controlled environment. Traditional hiatal hernia treatments involve real-life surgical practice, which can be risky for patients. Unlike these conventional methods, VLaHHS allows for repeated practice without any harm, helping surgeons refine their skills before performing actual surgeries. This innovative approach could lead to better surgical outcomes and increased confidence among medical professionals.

What evidence suggests that the Virtual Laparoscopic Hiatal Hernia Simulator is effective for improving surgical skills?

Research has shown that virtual reality tools like the Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) can greatly enhance surgical training. In this trial, participants in the Simulation Group will use the VLaHHS to practice and improve their skills in a safe and controlled setting. Early results from other studies suggest that those trained with simulators like VLaHHS perform better in real surgeries compared to those who do not use this training. The simulator aims to increase confidence and skill, potentially leading to better outcomes for patients. Meanwhile, participants in the Control Group will continue with their normal residency training without VLaHHS. ^{1 4 6 7 8}

Who Is on the Research Team?

Ganesh Sankaranarayanan, Ph.D.

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for General Surgery residents who are interested in improving their laparoscopic hiatal hernia repair skills. It's not open to other types of residents or non-residents.

Inclusion Criteria

General Surgery (GS) residents

Exclusion Criteria

Residents other than GS

Participants who are not residents.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Orientation and Pre-test

Participants receive a guided, hands-on orientation to the task and take a pre-test to mark their baseline performance

1 week

1 visit (in-person)

Training

Participants in the Simulation Group train with VLaHHS for an hour a day, 5 days a week, for up to 3 weeks

3 weeks

15 sessions (in-person)

Post-test and Skill Assessment

Skill learning and transfer-of-training are assessed immediately following training and again after two weeks

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for skill retention and transfer of skills using various assessment tools

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS)

Trial Overview The study tests a Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) to see if it helps surgeons get better at real-life surgeries. The simulator's effectiveness will be evaluated through surveys, scenario development, and three phases assessing different aspects of validity.

How Is the Trial Designed?

Group I: Group 1 (Simulation Group) Experimental Treatment 1 Intervention

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 II: Group 2 (Control Group) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06974383

Development and Validation of Virtual Laparoscopic Hiatal ... The goal of this study is to establish the face, content, discriminant and predictive validity of the Virtual Laparoscopic Hiatal Hernia ...

2. news.bswhealth.com news.bswhealth.com/en-US/releases/nih-awards-baylor-scott-white-research-institute-ro1-grant-for-surgical-simulator-study

NIH Awards Baylor Scott & White Research Institute RO1 ... A virtual reality simulator designed with the intent to improve hiatal hernia surgery training, and ultimately, surgical outcomes.

3. ichgcp.net ichgcp.net/amp/clinical-trials-registry/537250-development-and-validation-of-virtual-laparoscopic-hiatal-hernia-simulator

Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS ... This clinical trial investigates the effectiveness of the Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) in training general surgery ...

4. withpower.com withpower.com/clinical-trials/for-hernia

Top Hernia Clinical Trials | Power The goal of this study is to establish the face, content, discriminant and predictive validity of the Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS). The ...

5. researchgate.net researchgate.net/publication/343728197_Robotic_Versus_Laparoscopic_Approach_to_Hiatal_Hernia_Repair_Results_After_7_Years_of_Robotic_Experience

Robotic Versus Laparoscopic Approach to Hiatal Hernia ... The clinical outcomes, however, have not been adequately evaluated. We report outcomes of laparoscopic and robotic hiatal hernia repairs.

6. reporter.nih.gov reporter.nih.gov/project-details/10020977

Project Details To address the gap in training for laparascopic hiatal hernia surgery, we propose to develop the Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) with ...

7. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01EB025247&arg_ProgOfficeCode=57

Award Information | HHS TAGGS R01EB025247: Development and Validation of a Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) ; Award Number: R01EB025247 ; ORGANIZATION: NATIONAL INSTITUTE ...

8. azolifesciences.com azolifesciences.com/news/20200714/Scientists-to-develop-virtual-reality-simulator-to-improve-training-on-hiatal-hernia-surgery.aspx

Scientists to develop virtual reality simulator to improve ... The study, titled Development and Validation of a Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS), will be led by principal investigator ...