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Same-day, Reduced Volume Bowel Preparation

NCT ID: NCT01044394

Last Updated: 2012-08-31

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

Brief Summary

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We seek to evaluate whether a same day, reduced liquid volume (2liters) polyethylene glycol (PEG-ELS) bowel preparation can achieve adequate colon cleansing in patients scheduled for afternoon colonoscopies. The primary outcome will be adequacy of the bowel preparation. Secondary outcomes will include Boston Bowel Preparation Scale score, patient compliance with completing the preparation, tolerability of the preparation, willingness to repeat the preparation, side effects, duration of procedure (endoscope insertion and withdrawal times), and polyp detection.

Detailed Description

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The diagnostic accuracy of colonoscopy depends on the quality of the preparation. The adequacy of the preparation determines whether complete visualization of the mucosa and identification of pathologic lesions is achieved. For reasons that are not entirely clear, colonoscopies scheduled in the afternoon have been identified as a risk factor for having an inadequate preparation. Standard bowel preparation regimens at BMC include polyethylene glycol- electrolyte solutions (PEG-ELS) in full (four liters) and reduced (two liters) forms. These laxatives are typically administered either the evening prior to the colonoscopy or in "split dose" (a portion the evening before and a portion the morning of the colonoscopy). The percent of failed colonoscopies due to a fair/poor preparation in our endoscopy unit is 17-20%. Our trial seeks to establish the efficacy and safety of a reduced volume PEG-ELS laxative given on the day of the colonoscopy.

Conditions

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Bowel Preparation

Keywords

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colonoscopy bowel preparation polyethylene glycol Quality in endoscopy Bowel Preparation for colonoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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same day, reduced volume PEG-ELS prep

Patients with colonoscopies scheduled in the afternoon will complete 2 liters of PEG-ELS solution the morning of their colonoscopy.

Group Type EXPERIMENTAL

polyethylene glycol (PEG-ELS) and bisacodyl tablets

Intervention Type DRUG

2 liters of PEG-ELS and 10mg of bisacodyl tablets once the morning of the colonoscopy

Interventions

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polyethylene glycol (PEG-ELS) and bisacodyl tablets

2 liters of PEG-ELS and 10mg of bisacodyl tablets once the morning of the colonoscopy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* English speaking patients referred for colonoscopy.

Exclusion Criteria

* Age \< 18,
* Pregnancy,
* History of bowel resection,
* Allergy to PEG-ELS, and
* Inability to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brian Jacobson

Associate professor of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian Jacobson, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medicial Center Gastroenterology Department

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H-28808

Identifier Type: -

Identifier Source: org_study_id