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A Colonic Tube to Improve Bowel Function in Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Constipation
Fecal Incontinence
Spinal Cord Injury
Intervention Device: Percutaneous endoscopic colostomy (PEC) tube
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects Receiving PEC Tube
Hide Arm/Group Description All Enrolled Subjects receiving PEC Placement
Period Title: Overall Study
Started 7
Completed 6
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title Subjects Receiving Percutaneous Endoscopic Colostomy (PEC)
Hide Arm/Group Description Quality of Life (QOL) evaluation before and after device placement
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  85.7%
>=65 years
1
  14.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
2
  28.6%
Male
5
  71.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
American Indian or Alaska Native
1
  14.3%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
  85.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Change in Bowel QoL
Hide Description

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.

Time Frame Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects completing both Intake and Exit assessments
Arm/Group Title Global SCI-QoL Score in Subjects Receiving PEC Tube SCI-Specific QoL Evaluation in Subjects Receiving PEC Tube
Hide Arm/Group Description:
Global SCI-QoL Score before and after device placement
SCI-Specific QoL evaluation before and after device placement
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.17  (3.55) -3.65  (1.263)
Time Frame Reporting includes the evaluation period of 6-18 months between Intake and Exit evaluations, as well as up to 24 month additional observation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects Receiving PEC Tube
Hide Arm/Group Description QoL evaluation before and after device placement
All-Cause Mortality
Subjects Receiving PEC Tube
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Subjects Receiving PEC Tube
Affected / at Risk (%) # Events
Total   1/7 (14.29%)    
Respiratory, thoracic and mediastinal disorders   
Death, unrelated * [1]  1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Pneumonia death during follow-up period
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subjects Receiving PEC Tube
Affected / at Risk (%) # Events
Total   1/7 (14.29%)    
Gastrointestinal disorders   
Fistula   1/7 (14.29%)  1
Renal and urinary disorders   
Hyponatremia   1/7 (14.29%)  1
Indicates events were collected by systematic assessment

Difficulty in recruitment from a limited population reduced our intended enrollment and prolonged our study.

This also reduced our statistical significance and limited our conclusions.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary F. Otterson, MD; Professor of Surgery
Organization: Medical College of Wisconsin and Zablocki VAMC Milwaukee, WI
Phone: 414-384-2000 ext 4-1619
EMail: Motterso@mcw.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00345397    
Other Study ID Numbers: B4203-R
First Submitted: June 27, 2006
First Posted: June 28, 2006
Results First Submitted: February 26, 2015
Results First Posted: May 22, 2015
Last Update Posted: February 1, 2019