Recruiting

3D Model Simulation

Sponsor:

University of Minnesota

Code:

NCT06583577

Conditions

Ostomy

Ileal Conduit

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3D Ostomy simulator

Study Details

Brief 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. 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.

Conditions

Ostomy

Ileal Conduit

Study ID

NCT06583577

Start date

Jul 30, 2024

Status verified date

Jul, 2026

Completion date

Jul 20, 2027

Anticipated

Primary completion date

Jul 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age>18, undergoing bowel diversion urologic surgery.

Exclusion Criteria:

  • Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: 3D model simulator preoperative education

Participants will receive standard preoperative education regarding ostomy care enhanced by the hands on use of a the ostomy simulator.

no intervention: Standard preoperative education

Participants will receive standard preoperative education.

Interventions

3D Ostomy simulator

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.

Primary outcome measure

  • Develop 3D printed model for urologic bowel diversion [ Time Frame: Models were created and approved prior to start of the project ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Bowan Yao, MD

612-625-7486yao00235@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Judith A Graziano, PhD

grazi005@umn.edu

Danniella Balangoy, BSc

balan017@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Patient education
  • Simulation
  • Quality of life
  • Ostomy adjustment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-22.