OstomyNCT06583577
Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
A study testing 3D Ostomy simulator in people with Ostomy and Ileal Conduit, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy, Ileal Conduit
- What is being tested?
- 3D Ostomy simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to 20 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18, undergoing bowel diversion urologic surgery.
Who cannot join
- Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55454
Judith A Graziano, PhD, grazi005@umn.edu
Danniella Balangoy, BSc, balan017@umn.edu
About this study
Official title: 3D Ostomy Simulation for Patient Education
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.
Read the detailed description
Inclusion Criteria:
Age>18 and planning to undergo bowel diversion urologic surgery.
Exclusion Criteria: Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.
Radom allocation and concealment: During a regularly schedule preoperative clinic visit participants that consent to the study will be asked to complete a short 36 item quality-of-life questionnaire (SF-36). The participant then be placed in either the experimental or comparator group using a random method similar to flipping a coin. Random allocation sequencing will be predetermined by a database specialist, who has no other role in the study. Therefore, all study staff, clinic staff and investigators will be blinded to the allocation sequencing, and will not be able to influence the group participants are assigned to.
Preoperative education: The clinic staff will provide participants with preoperative education according to their group assignment. Participants in the experimental group, will receive standard ostomy education supplemented by use of the simulation model. Those allocated to the comparator group will receive standard preoperative education.
Surveys: During the preoperative visit prior to receiving education, all participants will be asked to complete a quality of life survey, the SF-36. After the education, participants will be asked to complete the Ostomy Adjustment scale (OAS), and a visual analog scale (VAS) indicating their satisfaction with the ostomy education.
During regular postoperative visits within 3 weeks, between 5-8 weeks and approximately 3 months after leaving the hospital, participants will be asked to complete the SF-36, the OAS, and VAS. All study procedures will be conducted at the surgeon's clinic.
- Conditions
- Ostomy, Ileal Conduit
- Being tested
- 3D Ostomy simulator
- Keywords
- Patient education, Simulation, Quality of life, Ostomy adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Ostomy simulatorDevice
The 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.
| Study group | Role | What they receive |
|---|---|---|
| 3D model simulator preoperative education | Experimental | Participants will receive standard preoperative education regarding ostomy care enhanced by the hands on use of a the ostomy simulator. Receives: Device: 3D Ostomy simulator |
| Standard preoperative education | No intervention | Participants will receive standard preoperative education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop 3D printed model for urologic bowel diversion
3D printed model for urinary bowel diversion education
Measured: Models were created and approved prior to start of the project
Quality of life using SF-36 scale
Determine differences between groups in QOL using the (36-Item Short Form Health Survey)SF-36 Scale.
Measured: Preoperatively before education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
Adjustment of Ostomy
Determine differences between groups in adjustment to ostomy using the ostomy adjustment scale (OAS) Scale.
Measured: Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
Satisfaction with ostomy education
Determine differences between groups in adjustment to ostomy using the Visual Analog Scale VAS Scale.
Measured: Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
Secondary outcomes (5)
Post operative hospital duration
Number of postoperative days until participant is deemed ready for hospital discharge
Measured: Day the patient is deemed ready for hospital discharge, up to 52 weeks
In-hospital mortality
Participant dies prior to discharge from hospital
Measured: Up to 12 weeks
Unplanned visit to urgent healthcare after discharge from the hospital
Participant goes to urgent care, emergency room
Measured: Measured at 3 weeks and 3 months
Hospital readmission after discharge from the hospital.
Patient has hospital admission due to ostomy surgery
Measured: Measured at 3 weeks and 3 months
Surgical site infection
Diagnosis of surgical site infection requiring treatment
Measured: Measured at 3 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start30 Jul 2024
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstomyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to two treatment groups. The experimental group will receive preoperative hands on education on stoma care using a new 3D model. The comparator group will receive standard preoperative education.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583577
- Sponsor's protocol ID
- 00020255
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2024
- Last updated
- 22 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Ostomy Simulation for Patient Education
- ClinicalTrials.gov ID
- NCT06583577
- Acronym / sponsor ID
- 00020255
- Conditions
- Ostomy, Ileal Conduit
- Keywords
- Patient education, Simulation, Quality of life, Ostomy adjustment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 4 Sep 2024 (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.
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.
Detailed description
Inclusion Criteria:
Age>18 and planning to undergo bowel diversion urologic surgery.
Exclusion Criteria: Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.
Radom allocation and concealment: During a regularly schedule preoperative clinic visit participants that consent to the study will be asked to complete a short 36 item quality-of-life questionnaire (SF-36). The participant then be placed in either the experimental or comparator group using a random method similar to flipping a coin. Random allocation sequencing will be predetermined by a database specialist, who has no other role in the study. Therefore, all study staff, clinic staff and investigators will be blinded to the allocation sequencing, and will not be able to influence the group participants are assigned to.
Preoperative education: The clinic staff will provide participants with preoperative education according to their group assignment. Participants in the experimental group, will receive standard ostomy education supplemented by use of the simulation model. Those allocated to the comparator group will receive standard preoperative education.
Surveys: During the preoperative visit prior to receiving education, all participants will be asked to complete a quality of life survey, the SF-36. After the education, participants will be asked to complete the Ostomy Adjustment scale (OAS), and a visual analog scale (VAS) indicating their satisfaction with the ostomy education.
During regular postoperative visits within 3 weeks, between 5-8 weeks and approximately 3 months after leaving the hospital, participants will be asked to complete the SF-36, the OAS, and VAS. All study procedures will be conducted at the surgeon's clinic.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to two treatment groups. The experimental group will receive preoperative hands on education on stoma care using a new 3D model. The comparator group will receive standard preoperative education.
| Arm | Type | Receives |
|---|---|---|
| 3D model simulator preoperative education | Experimental | Device: 3D Ostomy simulatorParticipants will receive standard preoperative education regarding ostomy care enhanced by the hands on use of a the ostomy simulator. |
| Standard preoperative education | No intervention | –Participants will receive standard preoperative education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age>18, undergoing bowel diversion urologic surgery.
Key exclusion criteria (1 listed)
- Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.
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 |
|---|---|---|
| 3D Ostomy simulatorThe 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. | Device | 3D model simulator preoperative education |
Primary outcome
Develop 3D printed model for urologic bowel diversion
Time frame: Models were created and approved prior to start of the project
3D printed model for urinary bowel diversion education
Quality of life using 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.
Determine differences between groups in QOL using the (36-Item Short Form Health Survey)SF-36 Scale.
Adjustment of Ostomy
Time frame: Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
Determine differences between groups in adjustment to ostomy using the ostomy adjustment scale (OAS) Scale.
Satisfaction with ostomy education
Time frame: Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.
Determine differences between groups in adjustment to ostomy using the Visual Analog Scale VAS Scale.
5 secondary outcomes
Post operative hospital duration
Time frame: Day the patient is deemed ready for hospital discharge, up to 52 weeks
In-hospital mortality
Time frame: Up to 12 weeks
Unplanned visit to urgent healthcare after discharge from the hospital
Time frame: Measured at 3 weeks and 3 months
Hospital readmission after discharge from the hospital.
Time frame: Measured at 3 weeks and 3 months
Surgical site infection
Time frame: Measured at 3 weeks and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Ostomy simulator in people with Ostomy and Ileal Conduit, run by University of Minnesota 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bowan Yao, MD (612-625-7486, yao00235@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop 3D printed model for urologic bowel diversion (time frame: Models were created and approved prior to start of the project). The study lists 4 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 22 Jul 2026.