Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-12-31

Brief Summary

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Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient preparation and colonoscopy. The aim of the investigators study is to compare the efficacy and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in hospitalized patients undergoing colonoscopy.

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Detailed Description

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This is a single-center, prospective, endoscopist-blinded study in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa scale between arms. Secondary end points are patient compliance and tolerance. N: 120 hospitalized patients scheduled for diagnostic colonoscopy.

Conditions

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Bowel Preparation for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Morning-only polyethylene glycol

One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy.

Group Type EXPERIMENTAL

Morning-only polyethylene glycol

Intervention Type OTHER

One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy

Split-dose polyethylene glycol

Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy.

Group Type ACTIVE_COMPARATOR

Split-dose polyethylene glycol

Intervention Type OTHER

Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy

Interventions

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Split-dose polyethylene glycol

Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy

Intervention Type OTHER

Morning-only polyethylene glycol

One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients scheduled to undergo diagnostic colonoscopy during hospitalization

Exclusion Criteria

* Critically ill/Intensive Care Unit patients
* Suspected bowel obstruction/perforation
* History of colon resection
* Patients with altered mental status/inability to provide informed consent
* Incarcerated patients
* Pregnant females

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No