Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

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.

Study Overview

• Status: Recruiting
• Conditions: Ostomy; Ileal Conduit
• Intervention / Treatment: Device: 3D Ostomy simulator

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bowan Yao, MD; Phone Number: 612-625-7486; Email: yao00235@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Recruiting
      • University of Minnesota
      • Contact: Judith A Graziano, PhD; Email: grazi005@umn.edu
      • Contact: Danniella Balangoy, BSc; Email: balan017@umn.edu
      • Sub-Investigator: Hamed Ahmadi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.
No Intervention: Standard preoperative education; Participants will receive standard preoperative education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop 3D printed model for urologic bowel diversion	3D printed model for urinary bowel diversion education	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.	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.	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.	Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative hospital duration	Number of postoperative days until participant is deemed ready for hospital discharge	Day the patient is deemed ready for hospital discharge, up to 52 weeks
In-hospital mortality	Participant dies prior to discharge from hospital	Up to 12 weeks
Unplanned visit to urgent healthcare after discharge from the hospital	Participant goes to urgent care, emergency room	Measured at 3 weeks and 3 months
Hospital readmission after discharge from the hospital.	Patient has hospital admission due to ostomy surgery	Measured at 3 weeks and 3 months
Surgical site infection	Diagnosis of surgical site infection requiring treatment	Measured at 3 weeks and 3 months

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Patient education; Simulation; Ostomy adjustment
• Other Study ID Numbers: 00020255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No