Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-11-30

Brief Summary

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The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are blinded to the randomization process.

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Detailed Description

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Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as "Golytely" will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel preparation. For the afternoon colonoscopies, the conventional PEG regimen given on the evening prior to the day of the colonoscopy will be compared with the novel PEG regimen given on the morning of the day of the colonoscopy. The comparison will be drawn for two measures - bowel cleansing effect measured from the questionnaire given to the gastroenterologists performing the colonoscopy and the patient tolerability evaluated from the information gathered from the patient's questionnaire.

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Polythylene Glycol (PEG) in the evening

Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy.

'Polyethylene Glycol afternoon'

Group Type ACTIVE_COMPARATOR

Polyethylene Glycol afternoon

Intervention Type DRUG

Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM

Polythylene Glycol (PEG) in the Morning

Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy.

'Polyethylene Glycol morning'

Group Type EXPERIMENTAL

Polyethylene Glycol morning

Intervention Type DRUG

Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM

Interventions

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Polyethylene Glycol afternoon

Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM

Intervention Type DRUG

Polyethylene Glycol morning

Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM

Intervention Type DRUG