Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

NCT06583577 | Recruiting

• 1 other identifier: 00020255
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Patient education; Simulation; Quality of life; Ostomy adjustment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Post operative hospital duration

  Day the patient is deemed ready for hospital discharge, up to 52 weeks

• In-hospital mortality

  Up to 12 weeks

• Unplanned visit to urgent healthcare after discharge from the hospital

  Measured at 3 weeks and 3 months

• Hospital readmission after discharge from the hospital.

  Measured at 3 weeks and 3 months

• Surgical site infection

  Measured at 3 weeks and 3 months

Study Arms (2)

3D model simulator preoperative education

EXPERIMENTAL

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

Device: 3D Ostomy simulator

Standard preoperative education

NO INTERVENTION

Participants will receive standard preoperative education.

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.

3D model simulator preoperative education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

RECRUITING

Central Study Contacts

Bowan Yao, MD

CONTACT

612-625-7486; yao00235@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The post-operative soma care nurses and statistician will be blinded to group allocation.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to two treatment groups. The experimental group will receive preoperative hands on education on stoma care using a new 3D model. The comparator group will receive standard preoperative education.

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: September 4, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)