Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06583577

3D Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

Led by University of Minnesota · Updated on 2025-08-08

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a realistic and anatomically accurate 3D printed simulation model to improve patient education before urologic bowel diversion surgeries. The study aims to determine if this model enhances patient knowledge, self-care skills, and confidence in ostomy care compared to standard education. It also assesses changes in quality of life and patient satisfaction, along with secondary outcomes like hospital stay length, mortality, urgent healthcare visits, readmissions, and infections. Participants are randomly assigned to either receive standard preoperative education enhanced by hands-on use of the 3D ostomy simulator or just standard education without the model. The 3D simulator is created using detailed imaging data and advanced 3D printing technology. Education occurs during a preoperative clinic visit, and participants complete various surveys before and after surgery to measure adjustment and satisfaction. Throughout the study, participants complete quality of life surveys (SF-36), Ostomy Adjustment scales, and satisfaction surveys before education, and again at follow-up visits within 3 weeks, between 5 and 8 weeks, and around 3 months after surgery. Outcomes including hospital duration, mortality, urgent care visits, readmissions, and infections are also monitored. All procedures and assessments take place at the surgeon's clinic over the course of approximately three months post-surgery.

CONDITIONS

Brief Title

Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Planning to undergo bowel diversion urologic surgery
Not Eligible

You will not qualify if you...

  • Current or prior ostomy formation
  • Cognitive impairment preventing care of a stoma
  • Current pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during a regularly scheduled preoperative clinic visit

Implementation

Duration - Single preoperative visit

Participants receive preoperative education according to their group assignment, either standard education or standard education plus hands-on use of the 3D ostomy simulator.

1 visit (in-person) for preoperative education and surveys

Post-operative Follow-up

Duration - Approximately 3 months after hospital discharge

Participants attend regular postoperative visits to complete quality of life, ostomy adjustment, and satisfaction surveys while being monitored for recovery and complications.

Visits within 3 weeks, between 5-8 weeks, and approximately 3 months post hospital discharge

Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55454

Actively Recruiting

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Research Team

B

Bowan Yao, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

2

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