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Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy

Not Applicable
Terminated
Conditions
Colonoscopy
Interventions
Registration Number
NCT00558376
Lead Sponsor
Sheba Medical Center
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
23
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2Sodium phosphateIngestion of 2 doses of sodium phosphate 45 cc
1polyethylene glycolIngestion of 3L polyethylene Glycol
Primary Outcome Measures
NameTimeMethod
Colon cleanliness at the second colonoscopywithin 24 hours of purgative ingestion, and within 30 minutes of colonoscopy
Secondary Outcome Measures
NameTimeMethod
Tolerability of purgative regimenwithin 24 hours of purgative ingestion

Trial Locations

Locations (1)

Sheba_Medical_Center

🇮🇱

Tel-Hashomer, Israel

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