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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 : Completed
First Posted : June 28, 2006
Results First Posted : May 22, 2015
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE June 27, 2006
First Posted Date  ICMJE June 28, 2006
Results First Submitted Date  ICMJE February 26, 2015
Results First Posted Date  ICMJE May 22, 2015
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE May 1, 2006
Actual Primary Completion Date March 31, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2006)
  • Safety:Monitor adverse events during implantation and
  • for as long as the device is implanted. Monitoring is based on a detailed risk analysis filed with the FDA.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2006)
  • Efficacy: Prospectively evaluate the ability of a PEG device to successfully function as a PC
  • in its clinically indicated application(irrigation will produce bowel function);
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Colonic Tube to Improve Bowel Function in Spinal Cord Injury
Official Title  ICMJE Percutaneous Colostomy for Bowel Management in Spinal Cord Injury
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Constipation
  • Fecal Incontinence
  • Spinal Cord Injury
Intervention  ICMJE Device: Percutaneous endoscopic colostomy (PEC) tube
PEC placement for antegrade enemas uses commercially available PEG tubes
Study Arms  ICMJE Experimental: Subjects Receiving PEC Tube
Percutaneous Endoscopic Colostomy Tube (PEC) Placement
Intervention: Device: Percutaneous endoscopic colostomy (PEC) tube
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2015)
7
Original Enrollment  ICMJE
 (submitted: June 27, 2006)
25
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date March 31, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00345397
Other Study ID Numbers  ICMJE B4203-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary F Otterson, MD Clement J. Zablocki VA Medical Center, Milwaukee, WI
PRS Account VA Office of Research and Development
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP