Duodenal AtresiaNCT04114279
Validation of a Totally Synthetic High Fidelity Laparoscopic Duodenal Atresia (DA) Surgical Simulator
A study testing Performance of laparoscopic duodenal atresia repair in people with Duodenal Atresia, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Duodenal Atresia
- What is being tested?
- Performance of laparoscopic duodenal atresia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2020to 28 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- surgical resident with at least 3 years of training
- surgical critical care fellow
- pediatric surgery fellow
- pediatric surgery attending
Who cannot join
- surgery trainee with less than 3 years of training
- non-surgeon
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Childrens Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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
- Being tested
- Performance of laparoscopic duodenal atresia repair
- Keywords
- surgical simulator
- Medical subject headings
- Familial duodenal atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance of laparoscopic duodenal atresia repairProcedure or surgery
completion of laparoscopic duodenal atresia repair in a surgical simulator
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Duodenal Atresia Repair | Experimental | All participants will attempt a laparoscopic duodenal atresia repair on the synthetic high fidelity simulator. Receives: Procedure: Performance of laparoscopic duodenal atresia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: The evaluation will be completed by participants immediately after performing the procedure.
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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
Measured: The evaluation will be completed by participants immediately after performing the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start28 Apr 2020 (estimated)
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Why it stopped: study approved and then COVID impacted recruitment. lost research staff after COVID and did not recruit for study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal AtresiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Zalieckas, Boston Children's Hospital
- Investigators
- Jill M Zalieckas, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114279
- Sponsor's protocol ID
- IRB-P00032040
- Status last verified
- Jul 2026
- First submitted
- 20 May 2019
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Totally Synthetic High Fidelity Laparoscopic Duodenal Atresia (DA) Surgical Simulator
- ClinicalTrials.gov ID
- NCT04114279
- Acronym / sponsor ID
- IRB-P00032040
- Conditions
- Duodenal Atresia
- Keywords
- surgical simulator
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study approved and then COVID impacted recruitment. lost research staff after COVID and did not recruit for study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 28 Apr 2020 (estimated)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Duodenal Atresia Repair | Experimental | Procedure: Performance of laparoscopic duodenal atresia repairAll participants will attempt a laparoscopic duodenal atresia repair on the synthetic high fidelity simulator. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- surgical resident with at least 3 years of training
- surgical critical care fellow
- pediatric surgery fellow
- pediatric surgery attending
Key exclusion criteria (2 listed)
- surgery trainee with less than 3 years of training
- non-surgeon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performance of laparoscopic duodenal atresia repaircompletion of laparoscopic duodenal atresia repair in a surgical simulator | Procedure or surgery | Laparoscopic Duodenal Atresia Repair |
Primary outcome
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.
Time frame: 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
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.
2. Realism of the DA simulator
Time frame: The evaluation will be completed by participants immediately after performing the procedure.
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
3. Utility of the simulator for teaching.
Time frame: The evaluation will be completed by participants immediately after performing the procedure.
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
3. Utility of the simulator for assessment of skills.
Time frame: The evaluation will be completed by participants immediately after performing the procedure.
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
3. Utility of the simulator for maintenance of skills
Time frame: The evaluation will be completed by participants immediately after performing the procedure.
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
3 secondary outcomes
1. Time to completion of the DA repair
Time frame: 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
Time frame: Completed within 1 year of the start of the study
3. Recommendations for improvement of the DA simulator
Time frame: The evaluation will be completed by participants immediately after performing the procedure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill M Zalieckas, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performance of laparoscopic duodenal atresia repair in people with Duodenal Atresia, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.