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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 3D printed model, the 3D Ostomy simulator, to help people learn about ostomy care, a surgical opening in the body used to remove waste. The trial aims to determine if this model improves patient knowledge, self-care skills, confidence, and satisfaction compared to standard education methods. Researchers are also examining its impact on recovery outcomes, such as hospital stay and the need for urgent healthcare. This trial suits adults preparing for surgery to create a bowel diversion (an alternative path for waste). As an unphased trial, it offers a unique opportunity to contribute to innovative educational tools that could enhance patient care and recovery.

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 prior data suggests that this 3D simulator is safe for patient education?

Research has shown that using a 3D ostomy simulator for teaching patients is safe. This tool helps people learn to care for their ostomy—a surgical opening for waste removal—in a realistic way. No reports have indicated any problems or safety issues with this learning model.

The simulator is neither a medicine nor a device used inside the body, so it doesn’t carry the same risks as medical treatments. Instead, it serves as a hands-on learning tool, making it very low-risk for users. The main goal is to help patients feel more confident in self-care and to improve their quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 3D Ostomy simulator because it represents a hands-on approach to ostomy education, enhancing standard preoperative training. Unlike traditional methods that rely solely on verbal and written instructions, this simulator provides a tactile experience, allowing patients to practice and better understand ostomy care before surgery. This immersive learning tool aims to boost patient confidence and potentially improve self-care outcomes, offering a more interactive and engaging way to prepare for life with an ostomy.

What evidence suggests that this 3D simulator is effective for ostomy education?

This trial will compare the effectiveness of standard preoperative education with and without a 3D Ostomy simulator. Studies have shown that 3D printed models for ostomy education can be very helpful. Research indicates that these models improve patients' understanding and management of ostomy care. Experts have found that 3D models effectively teach both healthcare providers and patients. Early results suggest that these models can boost patient confidence and satisfaction with their care. While researchers continue to collect data, the hands-on experience with 3D models appears to enhance learning compared to traditional methods. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-ostomy-6-2024-7705e

3D Simulator for Ostomy 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06583577/ostomy-simulation-for-patient-education-prior-to-urologic-bowel-diversion-surgeries

Ostomy Simulation for Patient Education Prior to Urologic ... The purpose of this study is to evaluate the feasibility of using a realistic and anatomically accurate 3D printed simulation model for ...

3. studyfinder.umn.edu studyfinder.umn.edu/studies/31590

Ostomy Simulation for Patient Education Prior to Urologic ... This research is being to see if a new 3D simulation model is helpful in teaching patients about care of their stomas after surgery.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11345116/

Acceptance of Virtual Reality Simulation Training for Stoma ... We examined the questionnaire study to assess the acceptance of VR simulation training for stoma care by healthcare providers.

5. researchgate.net researchgate.net/publication/355001189_Development_manufacture_and_initial_assessment_of_validity_of_a_3-dimensional-printed_bowel_anastomosis_simulation_training_model

(PDF) Development, manufacture and initial assessment of ... Conclusion: Experts found the 3D-printed bowel anastomosis simulator to be an appropriate tool for the education of surgical residents, based on ...

6. amazon.com amazon.com/MedEduQuest-Simulator-Educational-Students-Guidance/dp/B0DFMBK3WX

Ostomy Care Simulator Kit, Educational Tool for Nurses ... Ostomy Care Simulator Kit, Educational Tool for Nurses, Medical Students & Patient Guidance, Hangable & Tabletop Design for Easy Use and Training.