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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-03-31

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.

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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.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Ingestion of 3L polyethylene Glycol

Group Type ACTIVE_COMPARATOR

polyethylene glycol

Intervention Type DRUG

Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy

2

Ingestion of 2 doses of sodium phosphate 45 cc

Group Type ACTIVE_COMPARATOR

Sodium phosphate

Intervention Type DRUG

Sodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy

Interventions

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polyethylene glycol

Single time 3 liters PEG, 250 cc every 15 minutes the day before colonoscopy

Intervention Type DRUG

Sodium phosphate

Sodium phosphate 45cc, 2 doses 4 hours apart the day before colonoscopy

Intervention Type DRUG

Other Intervention Names

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Meroken New, Polyethylene glycol 3350, Taro, Israel Sodium phosphate solution; Soffodex, Dexxon, Israel

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No