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Procedure

Performance of laparoscopic duodenal atresia repair for Duodenal Atresia

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

Study 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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
1. Time to completion of the DA repair
2. Anastomosis quality
3. Recommendations for improvement of the DA simulator

Trial Design

1Treatment groups
Experimental Treatment
Group I: Laparoscopic Duodenal Atresia RepairExperimental Treatment1 Intervention
All participants will attempt a laparoscopic duodenal atresia repair on the synthetic high fidelity simulator.

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,690 Total Patients Enrolled
Jill M Zalieckas, MD, MPHPrincipal InvestigatorBoston Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Validation of a Totally Synthetic High Fidelity Laparoscopic Duodenal Atresia (DA) Surgical Simulator
Jill Zalieckas 2019. "Validation of a Totally Synthetic High Fidelity Laparoscopic Duodenal Atresia (DA) Surgical Simulator". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04114279.
~7 spots leftby Apr 2025
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