A Colonic Tube to Improve Bowel Function in Spinal Cord Injury

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.

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