A Colonic Tube to Improve Bowel Function in Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT00345397
• Recruitment Status: Completed
• First Posted: June 28, 2006
• Results First Posted: May 22, 2015
• Last Update Posted: February 1, 2019
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Constipation; Fecal Incontinence; Spinal Cord Injury	Device: Percutaneous endoscopic colostomy (PEC) tube	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Percutaneous Colostomy for Bowel Management in Spinal Cord Injury
• Actual Study Start Date: May 1, 2006
• Actual Primary Completion Date: March 31, 2014
• Actual Study Completion Date: December 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Subjects Receiving PEC Tube; Percutaneous Endoscopic Colostomy Tube (PEC) Placement	Device: Percutaneous endoscopic colostomy (PEC) tube; PEC placement for antegrade enemas uses commercially available PEG tubes

Outcome Measures

Primary Outcome Measures :

1. Change in Bowel QoL [ Time Frame: Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement ]

   Spinal Cord Injury (SCI) -Specific, 20-Question QoL Instrument used a Visual Analog Scale (VAS) for each item.

   These were scored by measurement and recording 1-10 along the scale (1 being best, 10 being worst) An average of the scores for the 20-items was calculated for each subject before and after Percutaneous Endoscopic Colostomy (PEC) Tube placement.

   A Global SCI-QoL Score was also recorded using the same VAS. The difference between these Intake and Exit scores was used to define change in SCI-Specific Quality of Life.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Wisconsin

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, United States, 53295-1000

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Mary F Otterson, MD; Clement J. Zablocki VA Medical Center, Milwaukee, WI

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00345397
• Other Study ID Numbers: B4203-R
• First Posted: June 28, 2006
• Results First Posted: May 22, 2015
• Last Update Posted: February 1, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

cecostomy; colonoscopy; colostomy; constipation; endoscopy, gastrointestinal; fecal incontinence; percutaneous; quality of life; spinal cord injury

Additional relevant MeSH terms:

Fecal Incontinence; Spinal Cord Injuries; Constipation; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Signs and Symptoms, Digestive; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases