Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06583577
Status
Recruiting
Apply to this trial

Conditions

  • Ileal Conduit
  • Ostomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 3D Ostomy simulator — DEVICE
    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 Details

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.

Key Dates

Start date
Jul 30, 2024
Status verified
Aug 2025
Primary completion
Jul 15, 2026
Completion
Jul 15, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55454
Judith A Graziano, PhD
[email protected]
Danniella Balangoy, BSc
[email protected]
Hamed Ahmadi, MD (SUB_INVESTIGATOR)

Find similar trials in Minneapolis, MN

By research site
University of Minnesota· Minneapolis, MN

Related Studies