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
  Purpose

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 Intervention
Spinal Cord Injury
Drug: Fleets Oral Sodium Phosphate Solution (OSPS)
Drug: Colyte
Drug: Dual (OSPS & Colyte)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Safety and Efficacy of Routine Colonoscopy Preparations

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Renal Function (GFR, creatinine clearance) [ Time Frame: <30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of bowel preparation (Ottawa Score) [ Time Frame: <30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum and urine samples


Enrollment: 330
Study Start Date: June 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00856440

Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
Investigators
Principal Investigator: Mark A. Korsten, MD VA Medical Center, Bronx
  More Information

No publications provided

Responsible Party: Korsten, Mark - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00856440     History of Changes
Other Study ID Numbers: B4162C-1, 2380-06-031
Study First Received: March 2, 2009
Last Updated: July 15, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
SCI

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 20, 2014