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

N/A

Waitlist Available

Led By Jill M Zalieckas, MD, MPH

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on the day of simulator testing for each participant. we anticipate simulator testing to be completed within 6 months of the start date of the study.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new laparoscopic simulator to see if it can help surgeons with different levels of experience learn and improve their skills. The study will involve recording participants' performance during a procedure, and then having experts rate the quality of the procedure. Surveys will also be completed by participants to give feedback on the simulator.

Eligible Conditions

Duodenal Atresia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on the day of simulator testing for each participant. we anticipate simulator testing to be completed within 6 months of the start date of the study.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on the day of simulator testing for each participant. we anticipate simulator testing to be completed within 6 months of the start date of the study.

This trial's timeline: 3 weeks for screening, Varies for treatment, and on the day of simulator testing for each participant. we anticipate simulator testing to be completed within 6 months of the start date of the study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

1. Performance on the simulator as measured by a composite score of the OSAT (Objective Structured Assessment of Technical Skill) GRS (Global Rating Scale) and task specific checklist.

2. Realism of the DA simulator

3. Utility of the simulator for assessment of skills.

+2 more

Secondary study objectives

1. Time to completion of the DA repair

2. Anastomosis quality

3. Recommendations for improvement of the DA simulator