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

NCT04114279 | Unknown

• 1 other identifier: IRB-P00032040
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Duodenal Atresia

Keywords

surgical simulator

Outcome Measures

Primary Outcomes (5)

• 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.

  Participant operative performance based on OSAT GRS: There are 6 categories that are graded on scale of 1-5, where 5 is best performance. Categories include: respect for tissue, time\&motion, instrument handling, flow of operation, knowledge of specific procedure, overall performance. A grade of 1-5 is given to each category. The task specific checklist ranks if the tasks involved in completion of procedure are 1. done correctly, 2. done incorrectly, 3. not done. There are 13 specific tasks for this procedure.

  The OSAT and task specific checklists will be completed upon review of the videos by two blinded independent reviewers after all participants have completed simulator testing. It will be completed within one year of the study start date

• 2. Realism of the DA simulator

  An evaluation of the trainer will be given to each participant upon completion of the procedure. The Evaluation includes a 5 point scale, where 5 is highly realistic, and 1 is unsure. The evaluation includes specific physical attributes of the trainer, realism of the materials, realism of the experience, ability to perform the specific tasks, and overall rating of the simulator. There is also a section for written comments

  The evaluation will be completed by participants immediately after performing the procedure.

• 3. Utility of the simulator for teaching.

  The Evaluation form includes a section on the utility of the trainer as a training tool with a 5 point Likert scale - 5 being has great value and 1 being has no value

  The evaluation will be completed by participants immediately after performing the procedure.

• 3. Utility of the simulator for assessment of skills.

  The Evaluation form includes a section on the utility of the trainer as a testing tool,with a 5 point Likert scale - 5 being has great value and 1 being has not value

  The evaluation will be completed by participants immediately after performing the procedure.

• 3. Utility of the simulator for maintenance of skills

  The Evaluation form includes a section on the utility of the trainer as a tool for maintenance of skills,with a 5 point Likert scale - 5 being has great value and 1 being has no value

  The evaluation will be completed by participants immediately after performing the procedure.

Secondary Outcomes (3)

• 1. Time to completion of the DA repair

  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.

• 2. Anastomosis quality

  Completed within 1 year of the start of the study

• 3. Recommendations for improvement of the DA simulator

  The evaluation will be completed by participants immediately after performing the procedure.

Study Arms (1)

Laparoscopic Duodenal Atresia Repair

EXPERIMENTAL

All participants will attempt a laparoscopic duodenal atresia repair on the synthetic high fidelity simulator.

Procedure: Performance of laparoscopic duodenal atresia repair

Interventions

Performance of laparoscopic duodenal atresia repair PROCEDURE

completion of laparoscopic duodenal atresia repair in a surgical simulator

Laparoscopic Duodenal Atresia Repair

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• surgical resident with at least 3 years of training
• surgical critical care fellow
• pediatric surgery fellow
• pediatric surgery attending

You may not qualify if:

• surgery trainee with less than 3 years of training
• non-surgeon

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Familial duodenal atresia

Study Officials

• Jill M Zalieckas, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill M Zalieckas, MD, MPH

CONTACT

617-355-9871; jill.zalieckas@childrens.harvard.edu

Ayca Toprak, MD, MEd

CONTACT

ayca.toprak@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate in Surgery

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: October 3, 2019
• Study Start: December 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)