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

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.

Study Overview

• Status: Recruiting
• Conditions: Duodenal Atresia
• Intervention / Treatment: Procedure: Performance of laparoscopic duodenal atresia repair

Detailed Description

All participants will be provided with chapters from a surgical atlas outlining the steps of a laparoscopic DA repair, as well as a video of a laparoscopic DA repair prior to testing the simulator. On the day of testing, they will also be given an opportunity to practice on the DA simulator. A pretesting survey will be completed to gather demographic information, surgical experience and self-reported comfort level at performing a laparoscopic DA repair. The survey responses will be used to stratify participants into experts (pediatric surgeons with ≥3 laparoscopic DA repairs and/or ≥5 advanced pediatric MIS procedures), intermediates (pediatric surgeons with <3 thoracoscopic TEF/EA repair or laparoscopic DA repairs and/or <5 advanced Pediatric MIS procedures) and novices (general surgeons or trainees without advanced Pediatric MIS experience) for analysis of results.

Participants will then be asked to perform a laparoscopic DA repair on the simulator. Their performance will be video recorded. Recordings include only the surgery being performed in the simulator, as a result there will be no identifying information in the recordings. Time to completion will be recorded. Two independent assessors will score the participants performance using the objective structured assessment tool (OSAT) global rating scale (GRS) and a task specific checklist. The repaired DA samples will be blinded and assessed for quality of anastomosis by scoring for completeness, patency, suture density, % of square knots, and leak pressures (see appendix 3).

Upon completion of the simulator testing a post-procedure survey will be completed by participants regarding their experience and to provide feedback on simulator.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill M Zalieckas, MD, MPH; Phone Number: 617-355-9871; Email: jill.zalieckas@childrens.harvard.edu
• Study Contact Backup: Name: Ayca Toprak, MD, MEd; Email: ayca.toprak@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Childrens Hospital
      • Contact: Jill M Zalieckas, MD, MPH; Phone Number: 617-355-9871; Email: jill.zalieckas@childrens.harvard.edu
      • Contact: Biren Modi; Phone Number: 617-355-9871

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic Duodenal Atresia Repair; All participants will attempt a laparoscopic duodenal atresia repair on the synthetic high fidelity simulator.	Procedure: Performance of laparoscopic duodenal atresia repair; completion of laparoscopic duodenal atresia repair in a surgical simulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Time to completion of the DA repair	The time to completion of the DA repair will be recorded during simulator testing. It is defined by initial insertion of the instrument into the DA simulator to the time the participant cuts the final knot.	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	Two blinded independent reviewers will review videos of procedures and the corresponding anastomosis specimen. They will rate the anastomosis quality based upon completeness (yes/no), patency (yes/no), suture density (length of incision and number of sutures - this is an evaluation of spacing of sutures. There is no optimal number, rather it is a balance of spacing appropriately to have enough sutures not to leak, but not too many, which will result in a prolonged procedure), % square knots (higher % is better), and leak pressures (high pressure is better).	Completed within 1 year of the start of the study
3. Recommendations for improvement of the DA simulator	Free text written feedback given by study participants on written section of evaluation	The evaluation will be completed by participants immediately after performing the procedure.

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Jill M Zalieckas, MD, MPH, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: surgical simulator
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Duodenal Diseases; Intestinal Obstruction; Duodenal Obstruction
• Other Study ID Numbers: IRB-P00032040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No