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Safety and Efficacy of Routine Colonoscopy Preparations

18 Years
Not Enrolling
Spinal Cord Injury

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Trial Information

Safety and Efficacy of Routine Colonoscopy Preparations

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.

Inclusion Criteria:

1. Patients already clinically indicated for colonoscopy examination

Exclusion Criteria:

1. Patients who are not a candidate for elective colonoscopy (i.e. those with recent
myocardial infarction, terminal illness, etc.)

2. Patients who have a contraindication for Colyte (i.e. those with colonic obstruction,

3. Patients who have a contraindication for Fleet OSPS (i.e. those with poor renal
function, class 2 or greater symptomatic heart failure, etc.)

4. Pregnancy

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Renal Function (GFR, creatinine clearance)

Outcome Time Frame:

<30 days

Safety Issue:


Principal Investigator

Mark A. Korsten, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Medical Center, Bronx


United States: Federal Government

Study ID:




Start Date:

June 2006

Completion Date:

December 2008

Related Keywords:

  • Spinal Cord Injury
  • SCI
  • Spinal Cord Injuries



VA Medical Center, BronxBronx, New York  10468