An observational study in Spinal Cord Injury, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-16.
Sponsored by US Department of Veterans Affairs · Observational
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.
Colonoscopy is a routine evaluation for screening of colorectal cancer in people over 50 and for those at increased genetic risk. Despite the large number of individuals requiring such screening, there has been little randomized, controlled research to determine the relative renal safety of oral colon preparation solutions that are used to evacuate the bowel in patients with "normal" kidney function, the best frequency of laxative dosing (e.g. 1 day vs. 2 day), and the quality of the colon cleansing that results from these different approaches. Reports of acute renal failure, secondary to nephrocalcinosis, following the commonly used oral phosphosoda preparation are increasingly recognized. It is our belief that this project will yield clinically relevant information that would have immediate clinical application for all persons receiving a colonoscopy. Since preparation for screening colonoscopy involves vigorous purging of stool from individuals without GI complaints, it also represents an opportunity to study the prevalence of clostridium difficile (C. diff) in this population. This may reveal important information regarding the epidemiology of this increasingly virulent and common enteric pathogen. A pilot screening program for asymptomatic C. diff, a common nosocomial pathogen, may reveal findings of clinical importance for preventing spread of this infection, and allow use of presumptive treatment during periods of increased risk.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 330 is above the median of 60 across 323 observational studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
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Veterans, SCI and able-bodied
Exclusion Criteria:
SCI
Drug: Fleets Oral Sodium Phosphate Solution (OSPS) · Drug: Colyte · Drug: Dual (OSPS & Colyte)
Able-bodied
Drug: Fleets Oral Sodium Phosphate Solution (OSPS) · Drug: Colyte · Drug: Dual (OSPS & Colyte)
Osmotic preparation for colonoscopy
Also known as: Phospho Soda
Lavage preparation for colonoscopy
Also known as: Golytely
Combined, two-day preparation utilizing both preparations
Renal Function (GFR, creatinine clearance)
Time frame: <30 days
Quality of bowel preparation (Ottawa Score)
Time frame: <30 days
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs