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Lack of study coordinator and time.
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This is a randomized study of standard versus extra ostomy education.
The purpose of this study is to evaluate the effectiveness of pre-operative and post-operative ostomy education compared to standard of care ostomy education.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | Subjects will receive standard ostomy education. |
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| Pre-Operative Education | Experimental | In addition to standard ostomy education, subjects will receive additional education pre-operatively. |
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| Two-week Post Operative Education | Experimental | In addition to standard ostomy education, subjects will receive additional education two weeks following surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard | Behavioral | Standard ostomy education |
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| Measure | Description | Time Frame |
|---|---|---|
| Stoma Quality of Life Scale (SQOLS) | The SQOLS assesses patient quality of life on a 5-point Likert type scale, where 1 = Never and 5 = Always. Higher scores indicate a greater self-reported quality of life. | Six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skin integrity at the ostomy site by lesion type | Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion type. | Six weeks |
| Skin integrity at the ostomy site by location |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce W Robb, MD | Indiana University, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health North Hospital | Carmel | Indiana | 46032 | United States |
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| Pre-operative Education | Behavioral | In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject. |
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| Two-week Post Operative Education | Behavioral | 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. |
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Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion location.
| Six weeks |
| Number of appliance changes | Subjects will be asked to record the number of wafer and/or bag changes completed during study participation in a patient diary. | Six weeks |
| Stoma Care Self-Efficacy Scale (SCSES) | The SCSES assesses patient quality of life on a 4-point Likert type scale, where 1 = Not At All and 5 = Almost Always. Higher scores indicate a greater self-reported quality of life related to self-confidence in stoma care. | Six weeks |