CLINICAL TRIAL

Performance of laparoscopic duodenal atresia repair for Duodenal Obstruction

Locally Advanced
Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a simulator can help surgeons improve their skills for performing a specific type of surgery.

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About the trial for Duodenal Obstruction

Eligible Conditions
Duodenal Atresia · Duodenal Obstruction

Treatment Groups

This trial involves 2 different treatments. Performance Of Laparoscopic Duodenal Atresia Repair is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Performance of laparoscopic duodenal atresia repair
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
surgical resident with at least 3 years of training
surgical critical care fellow
pediatric surgery fellow
pediatric surgery attending
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 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.
Screening: ~3 weeks
Treatment: Varies
Reporting: 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.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Performance of laparoscopic duodenal atresia repair will improve 5 primary outcomes and 3 secondary outcomes in patients with Duodenal Obstruction. Measurement will happen over the course of The evaluation will be completed by participants immediately after performing the procedure..

3. Utility of the simulator for teaching.
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
THE EVALUATION WILL BE COMPLETED BY PARTICIPANTS IMMEDIATELY AFTER PERFORMING THE PROCEDURE.
3. Utility of the simulator for assessment of skills.
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
THE EVALUATION WILL BE COMPLETED BY PARTICIPANTS IMMEDIATELY AFTER PERFORMING THE PROCEDURE.
2. Realism of the DA simulator
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
THE EVALUATION WILL BE COMPLETED BY PARTICIPANTS IMMEDIATELY AFTER PERFORMING THE PROCEDURE.
3. Recommendations for improvement of the DA simulator
THE EVALUATION WILL BE COMPLETED BY PARTICIPANTS IMMEDIATELY AFTER PERFORMING THE PROCEDURE.
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.
3. Utility of the simulator for maintenance of skills
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
THE EVALUATION WILL BE COMPLETED BY PARTICIPANTS IMMEDIATELY AFTER PERFORMING THE PROCEDURE.
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.
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.
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
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Who is running the study

Principal Investigator
J. Z.
Jill Zalieckas, Associate in Surgery
Boston Children's Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for duodenal obstruction?

In most patients with obstructive duodenal disease, surgical removal of the dilated loops of small intestine leads to resolution of symptoms. In the remainder, palliative therapy (e.g., parenteral nutrition or medications) must be employed.

Anonymous Patient Answer

What causes duodenal obstruction?

Duodenal obstruction is associated with a variety of causes, including malignancy and congenital abnormalities. Duodenal obstruction may, therefore, present with a wide variety of causes. For patients with suspected duodenal obstruction, a thorough comprehensive medical workup is warranted.

Anonymous Patient Answer

What is duodenal obstruction?

DUOD obstruction is a rare and infrequent disease with most patients presenting late, resulting in poor outcome. It is a cause of severe vomiting and abdominal/chest pain. DUOD may be the second most common cause of small bowel obstruction (SBO), following post bowel surgery ileus. Duodenal obstruction is an indication of the need for surgical exploration. It is important to perform prompt diagnosis and treatment. Surgical treatment of the duodenal obstruction should include the resection and reconstruction of the duodenum.

Anonymous Patient Answer

Can duodenal obstruction be cured?

Duodenal fistula is a lethal condition requiring laparotomy in almost all cases; the cure rates with endoscopic and fluoroscopic approaches are low in such cases, but are similar to those reported elsewhere.

Anonymous Patient Answer

How many people get duodenal obstruction a year in the United States?

About 500 people will be diagnosed with duodenal obstruction in the United States per year. As surgeons and gastroenterologists become more aware of this condition, their referral rates will decrease.

Anonymous Patient Answer

What are the signs of duodenal obstruction?

The signs of duodenal obstruction vary greatly according with the size of obstruction and may include nausea, vomiting, loss of appetite, weight loss, and abdominal pain.

Anonymous Patient Answer

Have there been other clinical trials involving performance of laparoscopic duodenal atresia repair?

We believe that we present proof that laparoscopic duodenal atresia repair is safe and effective in selected patients. This type of operation has to be proposed as the gold standard, but future multicenter randomized prospective studies are warranted.

Anonymous Patient Answer

Does duodenal obstruction run in families?

Gastroesophageal reflux disease is a relatively common diagnosis among patients with duodenal obstruction. Genetic loci with major diagnostic significance, including loci outside major reflux-related genes, were identified as new genetic loci for duodenal obstruction.

Anonymous Patient Answer

Who should consider clinical trials for duodenal obstruction?

The medical community should be aware of the [poor outcomes associated with surgical management of duodenal obstruction]. A prospective clinical trial of surgery for duodenal obstruction is reasonable. However, patients should be informed that the likelihood of survival is poor for individuals with duodenal obstruction, even for those who receive surgery in a reasonable survival time and only with surgery-related complications. The need for a prospective trial remains undefined.

Anonymous Patient Answer

Have there been any new discoveries for treating duodenal obstruction?

There have been many advances in the management of duodenal obstruction in the past century. Nevertheless, there are still many problems to be solved. One of them is how to reduce the incidence of choledochal cysts. It will be necessary to explore more approaches to treat them. Nevertheless, other technical problems in the management of duodenal obstruction will be required in the future.

Anonymous Patient Answer

What is the latest research for duodenal obstruction?

Although recent investigations do not reveal a definitive etiology, they are useful to identify the key characteristics in the development of the intestinal obstruction in patients with duodenal obstruction.

Anonymous Patient Answer

Is performance of laparoscopic duodenal atresia repair safe for people?

There is an increased risk of complications, including anastomotic leakage and wound infection, in the subset of patients who require conversion from an open technique. These patients should be carefully considered for early surgical intervention and close monitoring.

Anonymous Patient Answer
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