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3D Simulator for Ostomy Education
N/A
Recruiting
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18, undergoing bowel diversion urologic surgery
Be older than 18 years old
Must not have
Cognitive function causing inability to care for stoma
Current or prior ostomy formation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 3 weeks and 3 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial will assess the use of a 3D printed model to educate patients undergoing urologic bowel diversion surgery. The study will compare patients who receive education using the 3D model to those
Who is the study for?
This trial is for adults over 18 who are about to have urologic bowel diversion surgery and haven't had an ostomy before. It's not for those with cognitive issues that prevent stoma care or pregnant individuals.
What is being tested?
The study tests if a realistic 3D printed simulator helps patients learn better about their upcoming ostomy procedure compared to standard education. Patients will be randomly placed in two groups, one using the simulator and one without it.
What are the potential side effects?
Since this trial involves educational tools rather than medical treatments, there are no direct side effects from interventions like drugs or surgeries. However, participants may experience varying levels of stress or anxiety related to learning new self-care skills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and will have surgery to redirect my bowel for urinary reasons.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot care for my stoma due to cognitive issues.
Select...
I have or had an ostomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at 3 weeks and 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 3 weeks and 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adjustment of Ostomy
Develop 3D printed model for urologic bowel diversion
Quality of life using SF-36 scale
+1 moreSecondary study objectives
Hospital readmission after discharge from the hospital.
In-hospital mortality
Post operative hospital duration
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 3D model simulator preoperative educationExperimental Treatment1 Intervention
Participants will receive standard preoperative education regarding ostomy care enhanced by the hands on use of a the ostomy simulator.
Group II: Standard preoperative educationActive Control1 Intervention
Participants will receive standard preoperative education.
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,918 Total Patients Enrolled