Sponsor study identifier
Secondary identifiers
observational
330
1 country
1
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)Periodic screening for colon cancer has become the standard of care in individuals over the age of 50. In this context, it is generally accepted that colonoscopy is the most sensitive modality for the detection of colon cancer and/or pre malignant colon pathology. As currently performed, however, colonoscopy requires that stool be eliminated from the colon before the examination. If stool remains in the colon, visualization of the bowel will be partially or completely impaired and limits the effectiveness of the screening. A number of methods are employed for purging the bowel of waste material but they generally involve either administration of a lavage (like a flush) solution (such as Colyte or Golytely) or of an osmotic laxative (such as sodium phosphate or magnesium citrate). Neither of these approaches is uniformly effective in all individuals and neither is without potential complications, especially on the kidneys. It is the intent of the proposed research to study the relative efficacy and safety of these preparations in both able-bodied individuals as well as people with spinal cord injury. To this end, we will randomize these groups to a lavage solution, a laxative or a combination of the two prior to a routine, clinically indicated colonoscopy. The quality of the preparation will be directly assessed during the colonoscopy and the effect of these preparations on kidney function will be determined. We suspect that when it comes to preparation for colonoscopy, one shoe does not fit all sizes. The proposed research should allow us to determine which form of preparation is least harmful while achieving optimal effectiveness.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 2008
Actual (reported)December 2008
Actual (reported)March 2, 2009
Actual (reported)March 5, 2009
Actual (reported)Renal Function (GFR, creatinine clearance)
<30 days
Quality of bowel preparation (Ottawa Score)
<30 days
SCI
Able-bodied
Osmotic preparation for colonoscopy
Lavage preparation for colonoscopy
Veterans, SCI and able-bodied
VA Medical Center, Bronx
The Bronx, New York, 10468, United States
Serum and urine samples
Mark A. Korsten, MD
VA Medical Center, Bronx
330 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2009
First Posted
March 5, 2009
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D
Combined, two-day preparation utilizing both preparations
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)Last Updated
July 16, 2010
Record last verified: 2010-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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