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A Colonic Tube to Improve Bowel Function in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT00345397
Recruitment Status : Active, not recruiting
First Posted : June 28, 2006
Results First Posted : May 22, 2015
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The investigators 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 or disease Intervention/treatment Phase
Constipation Fecal Incontinence Spinal Cord Injury Device: Percutaneous endoscopic colostomy (PEC) tube Not Applicable

Detailed Description:
  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 Investigational Device Exemption (IDE). Specific objectives include:

    Safety: Monitor adverse events, especially for any evidence suggesting that use of Percutaneous Endoscopic Gastrostomy (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.

  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 Veterans Affairs Medical Center (VAMC). These patients have already been pre-screened for prevalence of bowel dysfunction, compliance, interest in research participation, and specific case finding. The investigators will mail a 7-Day Diary of bowel management to the 111 potential subjects that the investigators 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.

  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 the 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Colostomy for Bowel Management in Spinal Cord Injury
Actual Study Start Date : May 1, 2006
Actual Primary Completion Date : March 31, 2014
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Subjects Receiving PEC Tube
Percutaneous Endoscopic Colostomy Tube (PEC) Placement
Device: Percutaneous endoscopic colostomy (PEC) tube
PEC placement for antegrade enemas uses commercially available PEG tubes




Primary Outcome Measures :
  1. Change in Bowel QoL [ Time Frame: Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement ]

    Spinal Cord Injury (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 before and after Percutaneous Endoscopic Colostomy (PEC) Tube placement.

    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.




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

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

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): NCT00345397


Locations
United States, Wisconsin
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Mary F Otterson, MD Clement J. Zablocki VA Medical Center, Milwaukee, WI

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00345397     History of Changes
Other Study ID Numbers: B4203-R
First Posted: June 28, 2006    Key Record Dates
Results First Posted: May 22, 2015
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
cecostomy
colonoscopy
colostomy
constipation
endoscopy, gastrointestinal
fecal incontinence
percutaneous
quality of life
spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Constipation
Fecal Incontinence
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Signs and Symptoms, Digestive
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases