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N/A Completed N=6 Randomized Other

Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator

Predictive Validity of VLaHHS
Source: ClinicalTrials.gov NCT06974383 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Skill Level in Participants as Assessed by Completion Time — 492.7; 1086.07 Seconds

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.

Outcome Measures

OutcomeResultp-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 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

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. Informational only — not medical advice.

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