Overview

This trial is active, not recruiting.

Conditions constipation, fecal incontinence, spinal cord injury
Treatment percutaneous endoscopic colostomy tube
Sponsor Department of Veterans Affairs
Start date May 2006
End date March 2014
Trial size 25 participants
Trial identifier NCT00345397, B4203-R

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
QOL evaluation over time
percutaneous endoscopic colostomy tube
PEC placement for antegrade enemas uses commercially available PEG tubes
(No Intervention)
QOL evaluation
(Experimental)
QOL evaluation before and after device placement
percutaneous endoscopic colostomy tube
PEC placement for antegrade enemas uses commercially available PEG tubes

Primary Outcomes

Measure
improved bowel quality of life
time frame: 1 year followup after device insertion

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Percutaneous Colostomy for Bowel Management in Spinal Cord Injury
Principal investigator Mary F Otterson, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.