Safety and Efficacy of Routine Colonoscopy Preparations

NCT00856440 | Completed

• 2 other identifiers: B4162C-12380-06-031
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

SCI

Outcome Measures

Primary Outcomes (1)

• Renal Function (GFR, creatinine clearance)

  <30 days

Secondary Outcomes (1)

• Quality of bowel preparation (Ottawa Score)

  <30 days

Study Arms (2)

1

SCI

Drug: Fleets Oral Sodium Phosphate Solution (OSPS); Drug: Colyte; Drug: Dual (OSPS & Colyte)

2

Able-bodied

Drug: Fleets Oral Sodium Phosphate Solution (OSPS); Drug: Colyte; Drug: Dual (OSPS & Colyte)

Interventions

Fleets Oral Sodium Phosphate Solution (OSPS) DRUG

Osmotic preparation for colonoscopy

Also known as: Phospho Soda

1; 2

Colyte DRUG

Lavage preparation for colonoscopy

Also known as: Golytely

1; 2

Dual (OSPS & Colyte) DRUG

Combined, two-day preparation utilizing both preparations

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans, SCI and able-bodied

You may qualify if:

• \. Patients already clinically indicated for colonoscopy examination

You may not qualify if:

• Patients who are not a candidate for elective colonoscopy (i.e. those with recent myocardial infarction, terminal illness, etc.)
• Patients who have a contraindication for Colyte (i.e. those with colonic obstruction, etc.)
• Patients who have a contraindication for Fleet OSPS (i.e. those with poor renal function, class 2 or greater symptomatic heart failure, etc.)
• Pregnancy

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine samples

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Golytely

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Mark A. Korsten, MD

  VA Medical Center, Bronx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 5, 2009
• Study Start: June 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 16, 2010

Record last verified: 2010-07

Locations

US (1)