Spinal Cord Injury Clinical Trial
Official title:
Percutaneous Colostomy for Bowel Management in Spinal Cord Injury
NCT number | NCT00345397 |
Other study ID # | B4203-R |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2006 |
Est. completion date | December 31, 2018 |
Verified date | January 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | December 31, 2018 |
Est. primary completion date | March 31, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Clement J. Zablocki VA Medical Center, Milwaukee, WI | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02574572 -
Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
|
Phase 1 | |
Recruiting |
NCT05941819 -
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
|
N/A | |
Completed |
NCT05265377 -
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
Recruiting |
NCT02331979 -
Improving Bladder Function in SCI by Neuromodulation
|
N/A | |
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Recruiting |
NCT02978638 -
Electrical Stimulation for Continence After Spinal Cord Injury
|
N/A | |
Withdrawn |
NCT02237547 -
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT02262234 -
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
|
Phase 1/Phase 2 | |
Completed |
NCT02161913 -
Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
|
N/A | |
Terminated |
NCT02080039 -
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
|
N/A | |
Completed |
NCT01884662 -
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
Completed |
NCT01642901 -
Zoledronic Acid in Acute Spinal Cord Injury
|
Phase 3 | |
Terminated |
NCT01433159 -
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
|
Phase 2 | |
Completed |
NCT01471613 -
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT02149511 -
Longitudinal Morphometric Changes Following SCI
|
||
Completed |
NCT01086930 -
Early Intensive Hand Rehabilitation After Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT01025609 -
Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
|
||
Terminated |
NCT01005615 -
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A |