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NCT00856440 · ClinicalTrials.gov registry record
Safety and Efficacy of Routine Colonoscopy Preparations
A clinical trial, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- 330
- Enrollment target
NCT00856440 is a clinical trial that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 330 participants.
The verdict
NCT00856440 has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- 330 participants
- Enrollment target
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.
Interventions
- DRUG Fleets Oral Sodium Phosphate Solution (OSPS)
- DRUG Colyte
- DRUG Dual (OSPS & Colyte)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2006-06 |
| Est. Completion | 2008-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00856440
The ClinicalTrials.gov registry entry for NCT00856440 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Fleets Oral Sodium Phosphate Solution (OSPS) is the first listed.
NCT00856440 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00856440 about?
NCT00856440 is a clinical study titled "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, co...
What is the current status of trial NCT00856440?
This trial is currently completed. The enrollment target is 330 participants. The study started on 2006-06. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00856440?
The interventions under investigation include: Fleets Oral Sodium Phosphate Solution (OSPS) (DRUG), Colyte (DRUG), Dual (OSPS & Colyte) (DRUG).
Who is sponsoring clinical trial NCT00856440?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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