Comparison of Rectal Trumpet and Standard Care

This study has been terminated.

( Unable to recruit target enrollment numbers )

First Received: March 24, 2006 Last Updated: December 19, 2007 History of Changes

Sponsors and Collaborators:	Christiana Care Health Services SePA Chapter of the American Association of Critical Care Nurses Wound Ostomy Continence Nurses Society and Hollister
Information provided by:	Christiana Care Health Services
ClinicalTrials.gov Identifier:	NCT00307476

Purpose

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	Intervention
Fecal Incontinence	Device: Rusch Nasopharyngeal Airway

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Clinical Comparison of the Rectal Trumpet and Standard Care in Acutely Ill Patients With Fecal Incontinence

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Urinary Incontinence

U.S. FDA Resources

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:

Skin integrity

Secondary Outcome Measures:

Ease of use
Cost effectiveness
Patient comfort

Estimated Enrollment:	100
Study Start Date:	September 2005
Study Completion Date:	June 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307476

Locations

United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19718
Christiana Care Health Systems-Wilmington
Wilmington, Delaware, United States, 19801

Sponsors and Collaborators

Christiana Care Health Services

SePA Chapter of the American Association of Critical Care Nurses

Wound Ostomy Continence Nurses Society and Hollister

Investigators

Principal Investigator:

Denise Netta-Turner, BSN

Christiana Care Health Systems

More Information

No publications provided

Study ID Numbers:	24200
Study First Received:	March 24, 2006
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00307476 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:

Fecal Incontinence
Fecal Containment Devices
Skin Integrity

Study placed in the following topic categories:

Signs and Symptoms
Fecal Incontinence
Digestive System Diseases
Urologic Diseases
Urination Disorders

Gastrointestinal Diseases
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Fecal Incontinence
Digestive System Diseases
Urologic Diseases

Urination Disorders
Gastrointestinal Diseases
Urinary Incontinence
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 11, 2009