A Colonic Tube to Improve Bowel Function in Spinal Cord Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00345397
First received: June 27, 2006
Last updated: July 8, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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: July 2016
Primary Completion Date: March 2014 (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:
  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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345397

Locations
United States, Wisconsin
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
Investigators
Principal Investigator: Mary F 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: July 8, 2014
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:
Constipation
Fecal Incontinence
Spinal Cord Injuries
Wounds and Injuries
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

ClinicalTrials.gov processed this record on August 28, 2014