MedTrace Logo

Safety and Efficacy of Routine Colonoscopy Preparations

NCT00856440 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2010-07-16

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury

Interventions

DRUG

Fleets Oral Sodium Phosphate Solution (OSPS)

Osmotic preparation for colonoscopy

DRUG

Colyte

Lavage preparation for colonoscopy

DRUG

Dual (OSPS & Colyte)

Combined, two-day preparation utilizing both preparations

Sponsors & Collaborators

Principal Investigators

  • Mark A. Korsten, MD · VA Medical Center, Bronx

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00856440 on ClinicalTrials.gov