Last reviewed · How we verify

Comparison of Rectal Trumpet and Standard Care

NCT00307476 NA WITHDRAWN

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.

Details

Lead sponsorChristiana Care Health Services
PhaseNA
StatusWITHDRAWN
Start dateThu Sep 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionMon Jun 25 2007 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States