Trial Outcomes & Findings for A Colonic Tube to Improve Bowel Function in Spinal Cord Injury (NCT NCT00345397)

Last Updated: 2019-02-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement

Results posted on

2019-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects Receiving PEC Tube All Enrolled Subjects receiving PEC Placement
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects Receiving PEC Tube All Enrolled Subjects receiving PEC Placement
Overall Study Death	1

Baseline Characteristics

A Colonic Tube to Improve Bowel Function in Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Receiving Percutaneous Endoscopic Colostomy (PEC) n=7 Participants Quality of Life (QOL) evaluation before and after device placement
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	7 participants n=99 Participants

PRIMARY outcome

Timeframe: Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement

Population: Subjects completing both Intake and Exit assessments

Outcome measures

Outcome measures
Measure	Global SCI-QoL Score in Subjects Receiving PEC Tube n=6 Participants Global SCI-QoL Score before and after device placement	SCI-Specific QoL Evaluation in Subjects Receiving PEC Tube n=6 Participants SCI-Specific QoL evaluation before and after device placement
Change in Bowel QoL	-4.17 units on a scale Standard Deviation 3.55	-3.65 units on a scale Standard Deviation 1.263

Adverse Events

Subjects Receiving PEC Tube

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Subjects Receiving PEC Tube n=7 participants at risk QoL evaluation before and after device placement
Respiratory, thoracic and mediastinal disorders Death, unrelated	14.3% 1/7 • Number of events 1 • Reporting includes the evaluation period of 6-18 months between Intake and Exit evaluations, as well as up to 24 month additional observation.

Other adverse events

Other adverse events
Measure	Subjects Receiving PEC Tube n=7 participants at risk QoL evaluation before and after device placement
Renal and urinary disorders Hyponatremia	14.3% 1/7 • Number of events 1 • Reporting includes the evaluation period of 6-18 months between Intake and Exit evaluations, as well as up to 24 month additional observation.
Gastrointestinal disorders Fistula	14.3% 1/7 • Number of events 1 • Reporting includes the evaluation period of 6-18 months between Intake and Exit evaluations, as well as up to 24 month additional observation.

Additional Information

Mary F. Otterson, MD; Professor of Surgery

Medical College of Wisconsin and Zablocki VAMC Milwaukee, WI

Phone: 414-384-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place