Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy - An Investigator Blinded Prospective Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Sheba Medical Center
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Colon cleanliness at the second colonoscopy
Study Overview
Brief Summary
The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, patients whose preparation was inadequate, will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.
Detailed Description
The aim of the study is to compare the efficacy of Polyethylene glycol versus sodium phosphate as purgative for colon preparation to colonoscopy, after the failure of preparation with sodium phosphate for first colonoscopy. The hypothesis tested is whether there is advantage for substituting the purgative used, as compared to repeating the colonoscopy with the same purgative.Briefly, the study will be composed of patients whose preparation was judged to be inadequate in a first colonoscopy by an endoscopist independent of the current study. They will be allocated randomly to a group that will receive 3L Polyethylene glycol versus a group that will receive sodium phosphate(45ccX2). Both groups will be instructed to extend low-fiber diet to 5 days. Cleanliness of the colon at colonoscopy will be assessed blindly by an experienced endoscopist.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Failed colonoscopy due to inadequate preparation
- •Able to understand and sign an informed consent
- •Preparation for frst colonoscopy consisted of sodium phosphate
Exclusion Criteria
- •Significant heart disease or CHF
- •Chronic Renal Failure
- •Allergy to any of the purgative ingredients
- •Pregnancy
- •Alcohol and/or drug abuse
- •Vomiting or aspiration
- •Suspected bowel obstruction
Arms & Interventions
1
Ingestion of 3L polyethylene Glycol
Intervention: polyethylene glycol (Drug)
2
Ingestion of 2 doses of sodium phosphate 45 cc
Intervention: Sodium phosphate (Drug)
Outcomes
Primary Outcomes
Colon cleanliness at the second colonoscopy
Time Frame: within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy
Secondary Outcomes
- Tolerability of purgative regimen(within 24 hours of purgative ingestion)
Investigators
Prof. Shomron BenHorin
Professor
Sheba Medical Center