Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
NCT Number: NCT06583577
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ostomy|Ileal Conduit
Interventions: DEVICE: 3D Ostomy simulator
Sponsor: University of Minnesota
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-07-30
Completion Date: 2026-07-15
Locations: University of Minnesota, Minneapolis, Minnesota, 55454, United States

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.

Primary Outcome Measures: 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: 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