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Safety and Efficacy of Routine Colonoscopy Preparations

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00856440
First received: March 2, 2009
Last updated: July 15, 2010
Last verified: July 2010

March 2, 2009
July 15, 2010
June 2006
December 2008   (final data collection date for primary outcome measure)
Renal Function (GFR, creatinine clearance) [ Time Frame: <30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00856440 on ClinicalTrials.gov Archive Site
Quality of bowel preparation (Ottawa Score) [ Time Frame: <30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Routine Colonoscopy Preparations
Safety and Efficacy of Routine Colonoscopy Preparations

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum and urine samples

Non-Probability Sample

Veterans, SCI and able-bodied

Spinal Cord Injury
  • Drug: Fleets Oral Sodium Phosphate Solution (OSPS)
    Osmotic preparation for colonoscopy
    Other Name: Phospho Soda
  • Drug: Colyte
    Lavage preparation for colonoscopy
    Other Name: Golytely
  • Drug: Dual (OSPS & Colyte)
    Combined, two-day preparation utilizing both preparations
  • 1
    SCI
    Interventions:
    • Drug: Fleets Oral Sodium Phosphate Solution (OSPS)
    • Drug: Colyte
    • Drug: Dual (OSPS & Colyte)
  • 2
    Able-bodied
    Interventions:
    • Drug: Fleets Oral Sodium Phosphate Solution (OSPS)
    • Drug: Colyte
    • Drug: Dual (OSPS & Colyte)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
December 2008
December 2008   (final data collection date for primary outcome measure)

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, etc.)
  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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00856440
B4162C-1, 2380-06-031
No
Korsten, Mark - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Mark A. Korsten, MD VA Medical Center, Bronx
Department of Veterans Affairs
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP