Different Levels of Patient Education for Care of Ostomy Site
NCT ID: NCT02036268
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
53 participants
INTERVENTIONAL
2012-05-31
2018-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Standard
Subjects will receive standard ostomy education.
Standard
Standard ostomy education
Pre-Operative Education
In addition to standard ostomy education, subjects will receive additional education pre-operatively.
Standard
Standard ostomy education
Pre-operative Education
In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.
Two-week Post Operative Education
In addition to standard ostomy education, subjects will receive additional education two weeks following surgery.
Standard
Standard ostomy education
Pre-operative Education
In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.
Two-week Post Operative Education
In addition to standard ostomy education and an additional pre-operative ostomy education session, another ostomy education session will be conducted with the subject two weeks post-op.
Interventions
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Standard
Standard ostomy education
Pre-operative Education
In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.
Two-week Post Operative Education
In addition to standard ostomy education and an additional pre-operative ostomy education session, another ostomy education session will be conducted with the subject two weeks post-op.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo surgery at IU Health North Hospital that will results in a temporary or permanent colostomy or ileostomy for a benign or malignant disease process.
* Are willing and able to provide written informed consent for participation in the study and authorization for release of health information.
* Are willing and able to attend up to two additional clinic visits at IU Health North Hospital for the purpose of ostomy teaching and care.
* Subjects who currently do NOT have a urostomy or any other type of urinary diversion and/or are NOT planning to have a urostomy or any other type of urinary diversion as part of the surgery procedures at the time of their surgery for placement of colostomy or ileostomy.
* Subjects who do NOT have any history of prior colostomy or ileostomy.
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Bruce W. Robb
Clinical Associate Professor of Surgery
Principal Investigators
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Bruce W Robb, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University, Department of Surgery
Locations
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Indiana University Health North Hospital
Carmel, Indiana, United States
Countries
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Other Identifiers
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1202007926
Identifier Type: -
Identifier Source: org_study_id
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