Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
- Conditions
- OstomyIleal Conduit
- Interventions
- Device: 3D Ostomy simulator
- Registration Number
- NCT06583577
- Lead Sponsor
- University of Minnesota
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Age>18, undergoing bowel diversion urologic surgery.
- Current or prior ostomy formation, cognitive function causing inability to care for stoma, current pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3D model simulator preoperative education 3D Ostomy simulator Participants will receive standard preoperative education regarding ostomy care enhanced by the hands on use of a the ostomy simulator.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States