A Colonic Tube to Improve Bowel Function in Spinal Cord Injury

NCT ID: NCT00345397

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-01
• Study Completion Date: 2018-12-31

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.

Conditions

Constipation; Fecal Incontinence; Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects Receiving PEC Tube

Percutaneous Endoscopic Colostomy Tube (PEC) Placement

Group Type: EXPERIMENTAL

Percutaneous endoscopic colostomy (PEC) tube

Intervention Type: DEVICE

PEC placement for antegrade enemas uses commercially available PEG tubes

Interventions

Percutaneous endoscopic colostomy (PEC) tube

PEC placement for antegrade enemas uses commercially available PEG tubes

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary F Otterson, MD

Role: PRINCIPAL_INVESTIGATOR

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Locations

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

B4203-R

Identifier Type: -

Identifier Source: org_study_id