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.

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.