Clinical trial NCT04114279: Validation of a Totally Synthetic High Fidelity Laparoscopic Duodenal Atresia (DA) Surgical Simulator
Official title: Validation of a Totally Synthetic High Fidelity Laparoscopic Duodenal Atresia (DA) Surgical Simulator
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Duodenal Atresia
Keywords: surgical simulator
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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.
timeFrame: 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
measure: 2. Realism of the DA simulator
timeFrame: The evaluation will be completed by participants immediately after performing the procedure.
measure: 3. Utility of the simulator for teaching.
timeFrame: The evaluation will be completed by participants immediately after performing the procedure.
measure: 3. Utility of the simulator for assessment of skills.
timeFrame: The evaluation will be completed by participants immediately after performing the procedure.
measure: 3. Utility of the simulator for maintenance of skills
timeFrame: The evaluation will be completed by participants immediately after performing the procedure.
Secondary outcomes:
measure: 1. Time to completion of the DA repair
timeFrame: 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.
measure: 2. Anastomosis quality
timeFrame: Completed within 1 year of the start of the study
measure: 3. Recommendations for improvement of the DA simulator
timeFrame: The evaluation will be completed by participants immediately after performing the procedure.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Childrens Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jill M Zalieckas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: