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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Polyethylene Glycol Versus Sodium Phosphate for Colon Preparation After Failure of First Preparation for Colonoscopy - An Investigator Blinded Prospective Controlled Trial

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: polyethylene glycol
* Drug: Sodium phosphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ingestion of 3L polyethylene Glycol | Drug: polyethylene glycol<br>* Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy<br>* Other names: Meroken New, Polyethylene glycol 3350, Taro, Israel;|
| Active Comparator: 2<br>Ingestion of 2 doses of sodium phosphate 45 cc | Drug: Sodium phosphate<br>* Sodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy<br>* Other names: Sodium phosphate solution; Soffodex, Dexxon, Israel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colon cleanliness at the second colonoscopy |  | within 24 hours of purgative ingestion, and within 30 minutes of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of purgative regimen |  | within 24 hours of purgative ingestion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy