ConstipationNCT00345397
A Colonic Tube to Improve Bowel Function in Spinal Cord Injury
A study testing Percutaneous endoscopic colostomy (PEC) tube in people with Constipation and Fecal Incontinence, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Fecal Incontinence, Spinal Cord Injury
- What is being tested?
- Percutaneous endoscopic colostomy (PEC) tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2006to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unstable clinical disease
- Untreatable co-morbidities affecting gut function
- Colonic disease or surgery that might impact safety of Percutaneous Colostomy tube placement
Trial locations and contacts
1 site in 1 country.
United States1 site
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000
About this study
Official title: Percutaneous Colostomy for Bowel Management in Spinal Cord Injury
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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
- Being tested
- Percutaneous endoscopic colostomy (PEC) tube
- Keywords
- cecostomy, colonoscopy, colostomy, constipation, endoscopy, gastrointestinal, fecal incontinence, percutaneous, quality of life, spinal cord injury
- Medical subject headings
- Constipation, Fecal Incontinence, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous endoscopic colostomy (PEC) tubeDevice
PEC placement for antegrade enemas uses commercially available PEG tubes
| Study group | Role | What they receive |
|---|---|---|
| Subjects Receiving PEC Tube | Experimental | Percutaneous Endoscopic Colostomy Tube (PEC) Placement Receives: Device: Percutaneous endoscopic colostomy (PEC) tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bowel QoL
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.
Measured: Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study start1 May 2006
- Primary completion31 Mar 2014
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary F Otterson, MD, Principal investigator, Clement J. Zablocki VA Medical Center, Milwaukee, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345397
- Sponsor's protocol ID
- B4203-R
- Status last verified
- Jan 2019
- First submitted
- 27 Jun 2006
- Last updated
- 1 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Colostomy for Bowel Management in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00345397
- Acronym / sponsor ID
- B4203-R
- Conditions
- Constipation, Fecal Incontinence, Spinal Cord Injury
- Keywords
- cecostomy, colonoscopy, colostomy, constipation, endoscopy, gastrointestinal, fecal incontinence, percutaneous, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2006 (actual)
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Jun 2006 (estimated)
- Results
- Posted 22 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects Receiving PEC Tube | Experimental | Device: Percutaneous endoscopic colostomy (PEC) tubePercutaneous Endoscopic Colostomy Tube (PEC) Placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Unstable clinical disease
- Untreatable co-morbidities affecting gut function
- Colonic disease or surgery that might impact safety of Percutaneous Colostomy tube placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous endoscopic colostomy (PEC) tubePEC placement for antegrade enemas uses commercially available PEG tubes | Device | Subjects Receiving PEC Tube |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary F Otterson, MD principal investigator
Clement J. Zablocki VA Medical Center, Milwaukee, WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous endoscopic colostomy (PEC) tube in people with Constipation and Fecal Incontinence, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bowel QoL (time frame: Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.