3D Simulator for Ostomy Education

Overseen By Bowan Yao, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Prior ostomy, Cognitive impairment, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the 3D Ostomy simulator treatment?

Research shows that using 3D models for patient education, like those used for stoma care, helps patients understand their condition better and become more self-reliant. This suggests that 3D simulators can be effective educational tools for ostomy care. ^{1 2 3 4 5}

How does the 3D Simulator for Ostomy Education treatment differ from other treatments for ostomy education?

The 3D Simulator for Ostomy Education is unique because it uses a virtual, interactive model to help patients and medical trainees understand complex anatomy and surgical procedures related to ostomies. Unlike traditional educational methods, this simulator provides a hands-on, visual learning experience that can improve preparedness and understanding of ostomy care. ^{1 4 6 7 8}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 who are about to have urologic bowel diversion surgery and haven't had an ostomy before. It's not for those with cognitive issues that prevent stoma care or pregnant individuals.

Exclusion Criteria

Current pregnancy

I cannot care for my stoma due to cognitive issues.

I have or had an ostomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Education

Participants receive preoperative education with or without the 3D model simulation

1 visit

1 visit (in-person)

Postoperative Follow-up

Participants complete surveys and are monitored for outcomes such as quality of life and surgical site infection

3 months

3 visits (in-person) at 3 weeks, 5-8 weeks, and 3 months post-surgery

Treatment Details

Interventions

• 3D Ostomy simulator

Trial Overview The study tests if a realistic 3D printed simulator helps patients learn better about their upcoming ostomy procedure compared to standard education. Patients will be randomly placed in two groups, one using the simulator and one without it.

Participant Groups

Group I: 3D model simulator preoperative education Experimental Treatment 1 Intervention

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

Group II: Standard preoperative education Active Control 1 Intervention

Participants will receive standard preoperative education.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

A new virtual anatomic model of the pelvic region has been developed to enhance medical education, surgical planning, and resident training, based on accurate CT and MR imaging data.

Feedback from surgical trainees indicates that this interactive model is an effective tool for learning and preparing for complex surgical procedures, with the potential for future integration into educational curricula and competency testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual pelvic anatomy and surgery simulator: an innovative tool for teaching pelvic surgical anatomy. Holubar, SD., Hassinger, JP., Dozois, EJ., et al.[2009]

A new low-cost simulator for stoma formation using porcine bowel and skin has been developed, providing an effective training tool for pediatric surgical registrars.

All trainees who used the simulator rated it as excellent and life-like, highlighting its potential for enhancing technical skills training, especially in low-middle-income countries where resources may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low-cost stoma simulator. Dagash, H., Lakhoo, K.[2021]

The study involved 5 patients aged 59 to 81 who received patient-specific three-dimensional stoma models for education after colorectal surgery, leading to improved understanding and self-reliance in managing their stomas.

Using these 3D models for education not only helped patients learn about their stomas and associated issues but also has the potential to reduce skin problems related to stoma care, highlighting the efficacy of personalized models in patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness Of Three-Dimensional Printing Models for Patients with Stoma Construction. Tominaga, T., Takagi, K., Takeshita, H., et al.[2020]

The Simbla TURBT simulator effectively covers 13 out of 21 procedural steps and 8 out of 17 pitfalls identified in a training needs analysis, demonstrating its relevance as an educational tool for urological residency training.

Participants rated the simulator highly for realism and usefulness, with 100% of intermediate and 96% of expert users finding it beneficial, while novices showed significantly longer resection times and more errors, highlighting the simulator's ability to differentiate skill levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Simbla TURBT Simulator in Urological Residency Training: From Needs Analysis to Validation. de Vries, AH., van Genugten, HG., Hendrikx, AJ., et al.[2018]

The Uro Trainer (UT) VR simulator demonstrated high face and construct validity in training for transurethral resection of bladder tumors (TUR-BT), with experienced consultants scoring significantly higher than novices, indicating its effectiveness in improving surgical skills.

Participants reported a high satisfaction rate (4.6 out of 5) with the VR training, although limitations were noted in tissue feedback and authenticity, suggesting areas for further development in the simulator.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a High-End Virtual Reality Simulator for Training Transurethral Resection of Bladder Tumors. Schulz, GB., Grimm, T., Buchner, A., et al.[2020]

The workshop focused on the development of surgical simulators using open-source simulation software, highlighting the importance of accessible technology in medical training.

Held at Stanford University in August 2006, the workshop aimed to equip participants with the skills to prototype effective surgical training tools, fostering innovation in medical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stanford university medical media and information technologies hosts open source surgical simulation workshop. Cornelius, CW., Heinrichs, L., Youngblood, P., et al.[2008]

A pilot study involving 10 participants (5 medical students and 5 surgical residents) found that a 3-D pelvic anatomy teaching module is perceived as easy to use and more effective than traditional teaching methods, with 90% of participants preferring it.

While all participants agreed the module teaches clinically relevant anatomy, 50% felt it lacked sufficient detail, suggesting areas for improvement in future iterations of the module.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual pelvic anatomy simulator: a pilot study of usability and perceived effectiveness. Hassinger, JP., Dozois, EJ., Holubar, SD., et al.[2019]

Virtual reality surgical simulations provide a safe and cost-effective training tool for neurosurgical procedures, offering advantages over traditional training models.

The study introduces a method to create patient-specific scenarios for training in endoscopic third ventriculostomy, addressing the common limitation of anatomical variation in existing simulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-specific pipeline to create virtual endoscopic third ventriculostomy scenarios. Armstrong, R., Eagleson, R., De Ribaupierre, S.[2017]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual pelvic anatomy and surgery simulator: an innovative tool for teaching pelvic surgical anatomy. [2009]

2. Germany pubmed.ncbi.nlm.nih.gov

A low-cost stoma simulator. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Usefulness Of Three-Dimensional Printing Models for Patients with Stoma Construction. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

The Simbla TURBT Simulator in Urological Residency Training: From Needs Analysis to Validation. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Validation of a High-End Virtual Reality Simulator for Training Transurethral Resection of Bladder Tumors. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Stanford university medical media and information technologies hosts open source surgical simulation workshop. [2008]

7. United States pubmed.ncbi.nlm.nih.gov

Virtual pelvic anatomy simulator: a pilot study of usability and perceived effectiveness. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-specific pipeline to create virtual endoscopic third ventriculostomy scenarios. [2017]