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Withdrawn NCT04114279

Validation of a Totally Synthetic High Fidelity Laparoscopic Duodenal Atresia (DA) Surgical Simulator

Conditions: Duodenal Atresia

Sex: All
Ages: 25 Years – N/A
Healthy volunteers: Yes
Phase: NA
Sponsor: Boston Children's Hospital

Location: Boston Childrens Hospital Boston Massachusetts

Summary

Surgeons with variable levels of experience in pediatric minimally invasive surgery (MIS) will be recruited to test the laparoscopic DA simulator. Baseline characteristics regarding their experience level in pediatric surgery, open and laparoscopic DA repairs and MIS surgery will be obtained from all participants. Prior to testing the simulator, participants will be provided with a video and book chapter describing how to perform the procedures and will be given an opportunity to practice on the simulators. Participant performance during a DA repair will be video recorded. Their identity will be blinded. Time to completion will be recorded. Two expert assessors will score their performance using a checklist and global performance rating scale. The quality of the duodenal anastomosis will be scored. The performance of novice, intermediate and expert surgeons will be compared to determine if the DA simulator is able to distinguish between performance of surgeons at various levels of experience. In addition, post-procedure survey will be completed by participants to rate the simulators based on its realism, usability and usefulness. Recommendations for improvement to the simulator will be sought.

Eligibility Criteria

Inclusion Criteria: * surgical resident with at least 3 years of training * surgical critical care fellow * pediatric surgery fellow * pediatric surgery attending Exclusion Criteria: * surgery trainee with less than 3 years of training * non-surgeon

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04114279). StuddyBuddy aggregates publicly available trial information.