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View Clinical Trial (Medical Research Study)
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A Colonic Tube to Improve Bowel Function in Spinal Cord Injury - NCT00345397-53295 (Clinical Trial 146173)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy146173.aspx
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** Please review additional "Nearby Studies" on right ----->
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| City: |
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Milwaukee |
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State:
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WI |
| Zip Code: |
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53295 |
| Conditions: |
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Constipation - Fecal Incontinence - Spinal Cord Injury |
| Purpose: |
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We want to know if placing a tube through the skin and into the colon to flush out the colon
is safe and effective in helping spinal cord veterans with bowel management.
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| Study summary: |
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1. Objectives: This Quality of Life (QoL) outcomes project studies the ability of
Percutaneous Colostomy (PC) to clinically benefit Spinal Cord Injury (SCI) patients'
bowel management and, thereby, their lives. This project runs under an umbrella IDE.
Specific objectives include:
Safety: Monitor adverse events, especially for any evidence suggesting that use of PEG
devices (high risk device) for PC might pose an unreasonable risk.
Efficacy: Prospectively evaluate the ability of a PEG device to successfully function
as a PC; a PC to work in its clinically indicated application;
the application to yield clinical benefits; and the clinical benefit to impact
QoL. Technical Questions: Seek insights on the use of Fluoroscopy and Re-Colonoscopy in
PC placement.
2. Research Design: In this 36-Month unblinded intervention trial, each SCI subject
serves as his or her own control. Using a commercially available PEG tube, PC is
placed colonoscopically, typically into the cecum. Technically, PC is directly
analogous to PEG. Pre-and post-PC bowel function and QoL will be defined and compared.
This will be the first rigorous prospective trial of endoscopic PC, especially for
antegrade irrigation in SCI adults. This project is intended to be foundational,
laying the groundwork for a variety of future studies.
3. Methodology: Subjects are drawn from the general SCI population at Zablocki VAMC.
These patients have already been pre-screened for prevalence of bowel dysfunction,
compliance, interest in research participation, and specific case finding. We will
mail a 7-Day Diary of bowel management to the 111 potential subjects that we identified
as having bowel management significantly impact their QoL. Successful completion of
the 7-Day Diary will serve as a secondary compliance screen and define baseline bowel
function. If the subject is interested in PC, additional evaluations, including
psychological testing and QoL instruments, will be undertaken pre-PC. Subsequent
re-evaluation with these same instruments will allow determination of physiological
efficacy and impact on QoL. Additional characterization of each subject may also allow
us to retrospectively define predictors of success related to bowel motility, clinical
characteristics, psychosocial factors, etc.
Underlying this Outcomes study is a standard Safety and Efficacy evaluation of the PC
procedure, itself. Details of technical aspects of implantation, risk attenuation
strategies, and data monitoring / reporting are outlined in cooperation with the FDA.
This IDE covers 25 patients but only under the direct supervision of Drs. Otterson or
Berger and only at the Zablocki VAMC.
4. Clinical Relationships: The potential clinical impact of PC is large. There are
45,000 SCI veterans and 200,000 SCI patients across the country. If our sample is
representative, 20% or more of these may benefit from PC. The secondary impact on
healthcare costs, caregiver burden, and even employability is yet to be determined. |
| Criteria: |
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Inclusion Criteria:
- SCI veteran followed at Zablocki VAMC
- High quality of life impact of bowels on survey
- Ability to cooperate with data collection and follow-up requirements
Exclusion Criteria:
- Unstable clinical disease
- Untreatable co-morbidities affecting gut function
- Colonic disease or surgery that might impact safety of Percutaneous Colostomy tube
placement |
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| Study is available at: |
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Zablocki VA Medical Center, Milwaukee
Milwaukee, WI 53295
United States
Primary Contact:
William L Berger, MD
Email: William.Berger@va.gov
Phone: 414-384-2000
Secondary Contact:
William L Berger, MD
Email: William.Berger@va.gov
Phone: (414) 384-2000 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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