RecruitingNot ApplicableNCT06583577

Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

3D Ostomy Simulation for Patient Education


Sponsor

University of Minnesota

Enrollment

40 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Age\>18, undergoing bowel diversion urologic surgery.

Exclusion Criteria1

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

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Interventions

DEVICE3D 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.


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT06583577


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