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Safety and Efficacy of Routine Colonoscopy Preparations

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ClinicalTrials.gov Identifier: NCT00856440
Recruitment Status : Completed
First Posted : March 5, 2009
Last Update Posted : July 16, 2010
Sponsor:
Information provided by:
VA Office of Research and Development

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Spinal Cord Injury Drug: Fleets Oral Sodium Phosphate Solution (OSPS) Drug: Colyte Drug: Dual (OSPS & Colyte)

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 330 participants
Time Perspective: Prospective
Official Title: Safety and Efficacy of Routine Colonoscopy Preparations
Study Start Date : June 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: GoLytely

Groups and Cohorts
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Group/Cohort Intervention/treatment
1
SCI
 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
2
Able-bodied
 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


Outcome Measures
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Primary Outcome Measures :
  1. Renal Function (GFR, creatinine clearance) [ Time Frame: <30 days ]

Secondary Outcome Measures :
  1. Quality of bowel preparation (Ottawa Score) [ Time Frame: <30 days ]

Biospecimen Retention:   Samples Without DNA
Serum and urine samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Veterans, SCI and able-bodied
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856440


Locations
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United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Mark A. Korsten, MD VA Medical Center, Bronx
More Information
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Responsible Party: Korsten, Mark - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00856440    
Other Study ID Numbers: B4162C-1
2380-06-031
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: July 16, 2010
Last Verified: July 2010
Keywords provided by VA Office of Research and Development:
SCI
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries