Document Detail


Safety and efficacy of a novel continence device in colostomy patients.
MedLine Citation:
PMID:  20847625     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: This study aimed to assess the safety and efficacy of a novel colostomy continence device. METHODS: This phase II, 142-day, open-label, nonrandomized, multicenter study enrolled patients who had end colostomies for ≥3 months. Study stages were usual pouching (21 days), wafer transition (14 days), and the device (107 days). During device wear, up to 8 hours per day, patients recorded the following outcomes in daily diaries: skin condition (if the wafer was changed); stoma color, moisture, and physical condition; and gastrointestinal symptoms. RESULTS: Of the 26 patients enrolled, 25 wore at least one device. The device was worn on 96% of study days and a mean of 6.8 hours per day. Adverse events were reported by 1 patient during the usual pouching 21-day period, by 5 patients during the wafer transition 14-day period, and by 15 patients during the device wear 107-day period. Stoma color and moisture were within normal range on all daily assessments. The device did not affect microbiology or vascularity. During device wear, patients had no unusual gastrointestinal symptoms or odor on >99% and 80% of days, respectively. The mean number of leaks per patient-month was 1.2 with usual pouching, 4.2 with the device overall, and 2.1 during the last 3 weeks with the device, suggesting a learning curve. Approximately 65% of patients preferred the device to usual pouching at the end of study. CONCLUSIONS: The novel continence device was safe and effective for up to 8 hours per day in colostomy patients.
Authors:
Terri R Maxwell; Denice Taylor; Ann M Durnal; Rebecca Wills; Dheerendra Kommala; Scott Wade
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Diseases of the colon and rectum     Volume:  53     ISSN:  1530-0358     ISO Abbreviation:  Dis. Colon Rectum     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-09-17     Completed Date:  2010-10-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372764     Medline TA:  Dis Colon Rectum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1422-31     Citation Subset:  IM    
Affiliation:
Image Specialties, St. Joseph, Missouri 64506, USA. terrimaxwell@netzero.com
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00809406
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Colonic Pouches*
Colostomy / adverse effects,  instrumentation*
Equipment Design
Fecal Incontinence / epidemiology,  prevention & control*
Female
Flatulence / epidemiology,  prevention & control*
Follow-Up Studies
Humans
Male
Middle Aged
Odors / prevention & control
Patient Satisfaction
Surgical Stomas*
Time Factors
Treatment Outcome

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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