Duodenal Atresia Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | December 2022 |
| Est. primary completion date | January 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 25 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Boston Childrens Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Children's Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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. | |
| Primary | 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. | |
| Primary | 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. | |
| Primary | 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 | 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. | |
| Secondary | 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 | |
| Secondary | 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. |