A Colonic Tube to Improve Bowel Function in Spinal Cord Injury
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.
Spinal Cord Injury
Device: Percutaneous endoscopic colostomy tube
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Percutaneous Colostomy for Bowel Management in Spinal Cord Injury|
- Change in Bowel Quality of Life [ Time Frame: Exit data collected 1 year(+/- 6 mo) after Intake data collection/PC insertion ] [ Designated as safety issue: No ]
SCI-Specific, 20-Question QoL Instrument used a Visual Analog Scale (VAS) for each item.
These were scored by measurement and recording 1-10 along the scale (1 being best, 10 being worst) An average of the scores for the 20-items was calculated for each subject at Intake and again at Exit.
A Global SCI-QoL Score was also recorded using the same VAS. The difference between these Intake and Exit scores was used to define change in SCI-Specific Quality of Life.
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||July 2016|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Subjects Receiving PEC Tube
Percutaneous Endoscopic Colostomy Tube Placement
Device: Percutaneous endoscopic colostomy tube
PEC placement for antegrade enemas uses commercially available PEG tubes
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; the ability of a PC to work in its clinically indicated application; the ability of the application to yield clinical benefits; and the ability of the clinical benefit to impact QoL. Technical Questions: Seek insights on the use of Fluoroscopy and Re-Colonoscopy in PC placement.
- 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.
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 an SCI-Specific, 20-question, QoL instrument will be undertaken pre-PC. Repeated measures at approximately 12 months 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345397
|United States, Wisconsin|
|Zablocki VA Medical Center, Milwaukee|
|Milwaukee, Wisconsin, United States, 53295-1000|
|Principal Investigator:||Mary F Otterson, MD||Zablocki VA Medical Center, Milwaukee|