Ileal Conduit, Ostomy
Conditions
Keywords
Patient education, Simulation, Quality of life, Ostomy adjustment
Brief 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.
Detailed description
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.
Interventions
DEVICE3D Ostomy simulator
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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The post-operative soma care nurses and statistician will be blinded to group allocation.
Intervention model description
Participants are randomly assigned to two treatment groups. The experimental group will receive preoperative hands on education on stoma care using a new 3D model. The comparator group will receive standard preoperative education.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Develop 3D printed model for urologic bowel diversion | Models were created and approved prior to start of the project | 3D printed model for urinary bowel diversion education |
| Quality of life using 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. | Determine differences between groups in QOL using the (36-Item Short Form Health Survey)SF-36 Scale. |
| Adjustment of Ostomy | 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. |
| Satisfaction with ostomy education | 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
| Measure | Time frame | Description |
|---|---|---|
| Post operative hospital duration | 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 |
| In-hospital mortality | Up to 12 weeks | Participant dies prior to discharge from hospital |
| Unplanned visit to urgent healthcare after discharge from the hospital | Measured at 3 weeks and 3 months | Participant goes to urgent care, emergency room |
| Hospital readmission after discharge from the hospital. | Measured at 3 weeks and 3 months | Patient has hospital admission due to ostomy surgery |
| Surgical site infection | Measured at 3 weeks and 3 months | Diagnosis of surgical site infection requiring treatment |
Countries
United States
Contacts
CONTACTBowan Yao, MD
Outcome results
None listed