- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01044394
Same-day, Reduced Volume Bowel Preparation
August 30, 2012 updated by: Brian Jacobson, Boston Medical Center
Evaluating the Effectiveness of a Same-day, Reduced Volume Polyethylene Glycol + Electrolyte Solution (PEG-ELS) Bowel Preparation for Afternoon Colonoscopies
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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2 liters of PEG-ELS and 10mg of bisacodyl tablets once the morning of the colonoscopy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary outcome: adequacy of bowel preparation.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Boston Bowel Preparation Scale scores, subject compliance, subject tolerability, adverse events, colonoscopy insertion & withdrawal time, number of repeat procedures needed due to inadequate bowel preparation, polyp detection, and adenoma detection.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Jacobson, MD, Boston Medicial Center Gastroenterology Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
January 5, 2010
First Submitted That Met QC Criteria
January 6, 2010
First Posted (Estimate)
January 7, 2010
Study Record Updates
Last Update Posted (Estimate)
August 31, 2012
Last Update Submitted That Met QC Criteria
August 30, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-28808
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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