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

NCT ID: NCT04114279

Last Updated: 2021-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Duodenal Atresia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Laparoscopic Duodenal Atresia Repair

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

Group Type: EXPERIMENTAL

Performance of laparoscopic duodenal atresia repair

Intervention Type: PROCEDURE

completion of laparoscopic duodenal atresia repair in a surgical simulator

Interventions

Performance of laparoscopic duodenal atresia repair

completion of laparoscopic duodenal atresia repair in a surgical simulator

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jill Zalieckas

Associate in Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill M Zalieckas, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Childrens Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jill M Zalieckas, MD, MPH

Role: CONTACT

jill.zalieckas@childrens.harvard.edu

617-355-9871

Ayca Toprak, MD, MEd

Role: CONTACT

ayca.toprak@childrens.harvard.edu

Facility Contacts

Jill M Zalieckas, MD, MPH

Role: primary

jill.zalieckas@childrens.harvard.edu

617-355-9871

Biren Modi

Role: backup

617-355-9871

Other Identifiers

IRB-P00032040

Identifier Type: -

Identifier Source: org_study_id