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

Withdrawn before enrolling · Not applicable

Conditions studied: Duodenal Atresia

In brief

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.

Key facts

Study ID
NCT04114279
Run by
Boston Children's Hospital
People needed
0
Starts
2020-04-28
Expected to finish
2020-04-28
Last updated by the study team
2026-07-13

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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