Ostomy Clinical Trial
Official title:
A Prospective, Single-Center Study to Assess the Impact of Pre- and Post-Surgical Ostomy Care Education on Patient Outcomes and Quality of Life
NCT number | NCT02036268 |
Other study ID # | 1202007926 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2012 |
Est. completion date | September 12, 2018 |
Verified date | May 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized study of standard versus extra ostomy education.
Status | Terminated |
Enrollment | 53 |
Est. completion date | September 12, 2018 |
Est. primary completion date | September 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age equal to or greater than 18 years of age at the time of consent. - 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: - Subjects not meeting any of the above eligibility criteria. |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Health North Hospital | Carmel | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Skin integrity at the ostomy site by location | Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion location. | Six weeks | |
Secondary | 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 | |
Secondary | 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 |
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