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NCT Number: NCT06583577

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-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.

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Key information

Conditions

Ostomy Ileal Conduit

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location status: Recruiting

Location contact

Danniella Balangoy, BSc

CONTACT

[email protected]

Hamed Ahmadi, MD

SUB_INVESTIGATOR

Judith A Graziano, PhD

CONTACT

[email protected]

About this study

Inclusion criteria

Age>18 and planning to undergo bowel diversion urologic surgery.

Exclusion criteria

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

Radom allocation and concealment: During a regularly schedule preoperative clinic visit participants that consent to the study will be asked to complete a short 36 item quality-of-life questionnaire (SF-36). The participant then be placed in either the experimental or comparator group using a random method similar to flipping a coin. Random allocation sequencing will be predetermined by a database specialist, who has no other role in the study. Therefore, all study staff, clinic staff and investigators will be blinded to the allocation sequencing, and will not be able to influence the group participants are assigned to.

Preoperative education: The clinic staff will provide participants with preoperative education according to their group assignment. Participants in the experimental group, will receive standard ostomy education supplemented by use of the simulation model. Those allocated to the comparator group will receive standard preoperative education.

Surveys: During the preoperative visit prior to receiving education, all participants will be asked to complete a quality of life survey, the SF-36. After the education, participants will be asked to complete the Ostomy Adjustment scale (OAS), and a visual analog scale (VAS) indicating their satisfaction with the ostomy education.

During regular postoperative visits within 3 weeks, between 5-8 weeks and approximately 3 months after leaving the hospital, participants will be asked to complete the SF-36, the OAS, and VAS. All study procedures will be conducted at the surgeon's clinic.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>18, undergoing bowel diversion urologic surgery.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Develop 3D printed model for urologic bowel diversion

    Time frame: Models were created and approved prior to start of the project

    3D printed model for urinary bowel diversion education

  2. Quality of life using SF-36 scale

    Time frame: Preoperatively before education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.

    Determine differences between groups in QOL using the (36-Item Short Form Health Survey)SF-36 Scale.

  3. Adjustment of Ostomy

    Time frame: Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.

    Determine differences between groups in adjustment to ostomy using the ostomy adjustment scale (OAS) Scale.

  4. Satisfaction with ostomy education

    Time frame: Preoperatively after education and within 3 weeks post hospital discharge, 5-8 weeks post hospital discharge, approximately 3 months post hospital discharge.

    Determine differences between groups in adjustment to ostomy using the Visual Analog Scale VAS Scale.

Secondary outcomes

  1. Post operative hospital duration

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

    Number of postoperative days until participant is deemed ready for hospital discharge

  2. In-hospital mortality

    Time frame: Up to 12 weeks

    Participant dies prior to discharge from hospital

  3. Unplanned visit to urgent healthcare after discharge from the hospital

    Time frame: Measured at 3 weeks and 3 months

    Participant goes to urgent care, emergency room

  4. Hospital readmission after discharge from the hospital.

    Time frame: Measured at 3 weeks and 3 months

    Patient has hospital admission due to ostomy surgery

  5. Surgical site infection

    Time frame: Measured at 3 weeks and 3 months

    Diagnosis of surgical site infection requiring treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Bowan Yao, MD

CONTACT

[email protected]

612-625-7486

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

3D Ostomy Simulation for Patient Education

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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