N/A N=7 Treatment

A Colonic Tube to Improve Bowel Function in Spinal Cord Injury

Constipation · Fecal Incontinence · Spinal Cord Injury

Bottom Line

View on ClinicalTrials.gov: NCT00345397 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

May 2015

Primary outcome: Primary: Change in Bowel QoL — -4.17; -3.65 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Percutaneous endoscopic colostomy (PEC) tube (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Bowel QoL	-4.17; -3.65	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00345397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.