Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
The purpose of this study is to evaluate the feasibility of using a realistic and anatomically accurate 3D printed simulation model for urologic bowel diversion patient education. Using a randomized two group design, we aim to determine whether the use of this model enhances patient knowledge, self-care skills, and confidence in ostomy care. We will also evaluate changes in quality of life (QOL) and patient satisfaction comparing patients exposed to the 3D model to those receiving standard of care.
The secondary aim of the study is to examine the differences between groups on patient outcomes including hospital duration, mortality, emergency/urgent health care visits, readmissions, and infections.
Participants will be educated using 3D model simulation as part of their preoperative education (experimental group) or have standard education without using the simulation model (comparator group). Both groups will complete quality of life (QOL), ostomy adjustment, and satisfaction with education surveys during their preoperative education visit and again during their routine follow-up visits (a) within 3 weeks after surgery, (b) between 5- 8 weeks after surgery, and (c) at approximately 3 months after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age>18, undergoing bowel diversion urologic surgery.
Disqualifiers
Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
3D Ostomy simulator
DeviceThe ostomy simulator is 3D printed model created in collaboration with Earl E. Bakken Medical Devices Center at the University of Minnesota. The anatomically accurate model is created by analyzing de-identified segmental imaging after bowel diversion surgeries. The Stratasys J750 Polyjet 3D Printer is utilized to create the simulator using usual synthetic material.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: 3D model simulator preoperative educationExperimental treatment 1 intervention
Group B: Standard preoperative educationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Develop 3D printed model for urologic bowel diversion
3D printed model for urinary bowel diversion education
Time frame
Models were created and approved prior to start of the project2
Quality of life using SF-36 scale
Determine differences between groups in QOL using the (36-Item Short Form Health Survey)SF-36 Scale.
Time frame
Preoperatively before education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.3
Adjustment of Ostomy
Determine differences between groups in adjustment to ostomy using the ostomy adjustment scale (OAS) Scale.
Time frame
Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.4
Satisfaction with ostomy education
Determine differences between groups in adjustment to ostomy using the Visual Analog Scale VAS Scale.
Time frame
Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.Secondary outcomes
1
Post operative hospital duration
Number of postoperative days until participant is deemed ready for hospital discharge
Time frame
Day the patient is deemed ready for hospital discharge, up to 52 weeks2
In-hospital mortality
Participant dies prior to discharge from hospital
Time frame
Up to 12 weeks3
Unplanned visit to urgent healthcare after discharge from the hospital
Participant goes to urgent care, emergency room
Time frame
Measured at 3 weeks and 3 months4
Hospital readmission after discharge from the hospital.
Patient has hospital admission due to ostomy surgery
Time frame
Measured at 3 weeks and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov