A Colonic Tube to Improve Bowel Function in Spinal Cord Injury
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Constipation Fecal Incontinence Spinal Cord Injury |
Device: Percutaneous endoscopic colostomy tube |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Percutaneous Colostomy for Bowel Management in Spinal Cord Injury |
- improved bowel quality of life [ Time Frame: 1 year followup after device insertion ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
QOL evaluation over time
|
Device: Percutaneous endoscopic colostomy tube
PEC placement for antegrade enemas uses commercially available PEG tubes
|
|
No Intervention: Arm 2
QOL evaluation
|
|
|
Experimental: Arm 3
QOL evaluation before and after device placement
|
Device: Percutaneous endoscopic colostomy tube
PEC placement for antegrade enemas uses commercially available PEG tubes
|
Detailed Description:
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.
- 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 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.
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: William L Berger, MD | (414) 384-2000 ext 46821 | William.Berger@va.gov |
| Contact: Mary Otterson, MD | (414) 384-2000 ext 41620 | mary.otterson@va.gov |
| United States, Wisconsin | |
| Zablocki VA Medical Center, Milwaukee | Recruiting |
| Milwaukee, Wisconsin, United States, 53295-1000 | |
| Contact: William L Berger, MD 414-384-2000 ext 46821 William.Berger@va.gov | |
| Contact: Mary Otterson, MD (414) 384-2000 ext 41620 mary.otterson@va.gov | |
| Principal Investigator: Mary Otterson, MD | |
| Sub-Investigator: William L. Berger, MD | |
| Principal Investigator: | Mary Otterson, MD | Zablocki VA Medical Center, Milwaukee |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00345397 History of Changes |
| Other Study ID Numbers: | B4203-R |
| Study First Received: | June 27, 2006 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Department of Veterans Affairs:
|
cecostomy colonoscopy colostomy constipation endoscopy, gastrointestinal |
fecal incontinence percutaneous quality of life spinal cord injury |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Constipation Fecal Incontinence Signs and Symptoms, Digestive Signs and Symptoms Rectal Diseases Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013