A Colonic Tube to Improve Bowel Function in Spinal Cord Injury

NCT00345397 | Completed Results FDA Device

• 1 other identifier: B4203-R
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Fecal Incontinence; Spinal Cord Injury

Keywords

cecostomy; colonoscopy; colostomy; constipation; endoscopy, gastrointestinal; fecal incontinence; percutaneous; quality of life; spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Subjects Receiving PEC Tube

EXPERIMENTAL

Percutaneous Endoscopic Colostomy Tube (PEC) Placement

Device: Percutaneous endoscopic colostomy (PEC) tube

Interventions

Percutaneous endoscopic colostomy (PEC) tube DEVICE

PEC placement for antegrade enemas uses commercially available PEG tubes

Subjects Receiving PEC Tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable clinical disease
• Untreatable co-morbidities affecting gut function
• Colonic disease or surgery that might impact safety of Percutaneous Colostomy tube placement

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-1000, United States

Location

MeSH Terms

Conditions

Constipation; Fecal Incontinence; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

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.

Results Point of Contact

• Title: Mary F. Otterson, MD; Professor of Surgery
• Organization: Medical College of Wisconsin and Zablocki VAMC Milwaukee, WI

Motterso@mcw.edu

414-384-2000

Study Officials

• Mary F Otterson, MD

  Clement J. Zablocki VA Medical Center, Milwaukee, WI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2006
• First Posted: June 28, 2006
• Study Start: May 1, 2006
• Primary Completion: March 31, 2014
• Study Completion: December 31, 2018
• Last Updated: February 1, 2019
• Results First Posted: May 22, 2015

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)