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

Tracking Information

• First Submitted Date: June 27, 2006
• First Posted Date: June 28, 2006
• Results First Submitted Date: February 26, 2015
• Results First Posted Date: May 22, 2015
• Last Update Posted Date: February 1, 2019
• Actual Study Start Date: May 1, 2006
• Actual Primary Completion Date: March 31, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 28, 2015)

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.

Original Primary Outcome Measures (submitted: June 27, 2006)

• Safety:Monitor adverse events during implantation and
• for as long as the device is implanted. Monitoring is based on a detailed risk analysis filed with the FDA.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: June 27, 2006)

• Efficacy: Prospectively evaluate the ability of a PEG device to successfully function as a PC
• in its clinically indicated application(irrigation will produce bowel function);

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Colonic Tube to Improve Bowel Function in Spinal Cord Injury
• Official Title: Percutaneous Colostomy for Bowel Management in Spinal Cord Injury
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Constipation
• Fecal Incontinence
• Spinal Cord Injury

Intervention

Device: Percutaneous endoscopic colostomy (PEC) tube

PEC placement for antegrade enemas uses commercially available PEG tubes

Study Arms

Experimental: Subjects Receiving PEC Tube

Percutaneous Endoscopic Colostomy Tube (PEC) Placement

Intervention: Device: Percutaneous endoscopic colostomy (PEC) tube

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 6, 2015): 7
• Original Enrollment (submitted: June 27, 2006): 25
• Actual Study Completion Date: December 31, 2018
• Actual Primary Completion Date: March 31, 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00345397
• Other Study ID Numbers: B4203-R
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: VA Office of Research and Development
• Study Sponsor: VA Office of Research and Development
• Collaborators: Not Provided

Investigators

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

• PRS Account: VA Office of Research and Development
• Verification Date: January 2019