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Comparison of Rectal Trumpet and Standard Care

This study has been terminated.
(Unable to recruit target enrollment numbers)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00307476
First Posted: March 28, 2006
Last Update Posted: December 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
SePA Chapter of the American Association of Critical Care Nurses
Wound Ostomy Continence Nurses Society and Hollister
Information provided by:
Christiana Care Health Services
  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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Comparison of the Rectal Trumpet and Standard Care in Acutely Ill Patients With Fecal Incontinence

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diarrhea - two episodes of loose or watery stool in a 12 hour period
  2. ≥ 18 years of age
  3. English-speaking patient or guardian
  4. Intact skin, may be reddened without breakdown
  5. Doctor's order for rectal trumpet if patient randomized to treatment group

Exclusion Criteria:

  1. prolapsed anal sphincter
  2. active rectal bleeding
  3. colorectal cancer
  4. bleeding precautions
  5. rectal tone rated 1 (gaping) or 2 (lax)
  Contacts and Locations
Information from the National Library of Medicine

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


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

ClinicalTrials.gov Identifier: NCT00307476     History of Changes
Other Study ID Numbers: 24200
First Submitted: March 24, 2006
First Posted: March 28, 2006
Last Update Posted: December 24, 2007
Last Verified: December 2007

Keywords provided by Christiana Care Health Services:
Fecal Incontinence
Fecal Containment Devices
Skin Integrity

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases