N/A N=6 Randomized Other

Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator

Predictive Validity of VLaHHS

Bottom Line

View on ClinicalTrials.gov: NCT06974383 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Skill Level in Participants as Assessed by Completion Time — 492.7; 1086.07 Seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Training with Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Jun 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Skill Level in Participants as Assessed by Completion Time	512.52; 1200.7	—
PRIMARY Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS	26.33; 17	—
PRIMARY Skill Level in Participants Assessed by NASA-TLX Questionnaire	32.66; 30.66	—
PRIMARY Skill Level in Participants as Assessed by Completion Time	512.52; 1200.7	—
PRIMARY Skill Level in Participants Assessed by Numerical Performance Score on the VLaHHS	26.33; 17	—
PRIMARY Skill Level in Participants Assessed by NASA-TLX Questionnaire	32.66; 30.66	—
PRIMARY Skill Retention in Participants as Assessed by Completion Time	504.38; 648.69	—
PRIMARY Skill Level in Participants Assessed by Numerical Performance Scale on the VLaHHS	27.66; 15.33	—
PRIMARY Skill Retention in Participants as Assessed by NASA-TLX Questionnaire	31.33; 31.33	—
PRIMARY Transfer of Skill in Participants as Assessed by Performance Score	52.66; 27.5	—

Summary

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. The goal of this phase of the study is to establish the learning curve and predictive validity of the VLaHHS. The study population includes GS residents. 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 Criteria

Inclusion Criteria

General Surgery (GS) residents

Exclusion Criteria

Residents other than GS
Participants who are not residents.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06974383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.