Comparison of Rectal Trumpet and Standard Care
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|ClinicalTrials.gov Identifier: NCT00307476|
Recruitment Status : Terminated (Unable to recruit target enrollment numbers)
First Posted : March 28, 2006
Last Update Posted : December 24, 2007
Primary: To determine the effectiveness of the rectal trumpet compared to the standard care in maintaining skin integrity in patients with fecal incontinence.
Hypothesis (H1): There will be no difference in the failure rates of rectal area skin integrity between subjects receiving the rectal trumpet and those receiving treatment as usual (staqndard care).
Secondary: To determine the ease of use, cost-effectiveness, and level of patient comfort with the rectal trumpet compared to the standard care in patients with fecal incontinence.
Secondary (exploratory) hypotheses:
There will be differences in the ease of use of the devices, costs of the devices, and patient comfort relative to the devices.
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Device: Rusch Nasopharyngeal Airway||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Comparison of the Rectal Trumpet and Standard Care in Acutely Ill Patients With Fecal Incontinence|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||June 2007|
- Skin integrity
- Ease of use
- Cost effectiveness
- Patient comfort
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307476
|United States, Delaware|
|Christiana Care Health Systems|
|Newark, Delaware, United States, 19718|
|Christiana Care Health Systems-Wilmington|
|Wilmington, Delaware, United States, 19801|
|Principal Investigator:||Denise Netta-Turner, BSN||Christiana Care Health Systems|