Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345397
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2006-06-27
Brief Title:
A Colonic Tube to Improve Bowel Function in Spinal Cord Injury
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Percutaneous Colostomy for Bowel Management in Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 45000 SCI Veterans and 200000 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
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 45000 SCI Veterans and 200000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None