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NCT06583577 · ClinicalTrials.gov registry record · NA
Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
A NA study of Ostomy and Ileal Conduit, sponsored by University of Minnesota.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06583577 is a NA study of Ostomy and Ileal Conduit that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 40 participants, below the 894-participant average among 6 other Ostomy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06583577, a NA study of Ostomy and Ileal Conduit, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE 3D Ostomy simulator
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-07-30 |
| Est. Completion | 2026-07-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06583577
The ClinicalTrials.gov registry entry for NCT06583577 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 894-participant average among 6 other Ostomy trials with a reported enrollment target (96% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Ostomy appearing as the primary indexed condition, and to 1 intervention - of which 3D Ostomy simulator is the first listed.
NCT06583577 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06583577 about?
NCT06583577 is a clinical study titled "Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries". 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-...
What is the current status of trial NCT06583577?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-07-30. Estimated completion is 2026-07-15.
What conditions does trial NCT06583577 study?
This clinical trial studies the following conditions: Ostomy, Ileal Conduit.
What interventions are being tested in trial NCT06583577?
The interventions under investigation include: 3D Ostomy simulator (DEVICE).
Who is sponsoring clinical trial NCT06583577?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06583577 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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