Clinical trial NCT00558376: Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy
Official title: Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy - An Investigator Blinded Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colonoscopy
Keywords: Colonoscopy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-11-14
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Colon cleanliness at the second colonoscopy
timeFrame: within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy
Secondary outcomes:
measure: Tolerability of purgative regimen
timeFrame: within 24 hours of purgative ingestion
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba_Medical_Center
Study officials:
affiliation: Sheba Medical Center
name: Shomron Ben-Horin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Benjamin Avidan, MD
role: PRINCIPAL_INVESTIGATOR
References: