Comparison of Rectal Trumpet and Standard Care

Withdrawn before enrolling · Not applicable

Conditions studied: Fecal Incontinence

In brief

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.

Key facts

Study ID

NCT00307476

Run by

Christiana Care Health Services

People needed

0

Starts

2005-09-01

Expected to finish

2007-06-25

Last updated by the study team

2023-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diarrhea - two episodes of loose or watery stool in a 12 hour period
• ≥ 18 years of age
• English-speaking patient or guardian
• Intact skin, may be reddened without breakdown
• Doctor's order for rectal trumpet if patient randomized to treatment group

You may not qualify if…

• prolapsed anal sphincter
• active rectal bleeding
• colorectal cancer
• bleeding precautions
• rectal tone rated 1 (gaping) or 2 (lax)

Where it is running

• Christiana Care Health Systems — Newark, Delaware, United States
• Christiana Care Health Systems-Wilmington — Wilmington, Delaware, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.