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Same-day, Reduced Volume Bowel Preparation

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ClinicalTrials.gov Identifier: NCT01044394
Recruitment Status : Withdrawn (A phase III RCT was published showing this approach is effective)
First Posted : January 7, 2010
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Brian Jacobson, Boston Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bowel Preparation Drug: polyethylene glycol (PEG-ELS) and bisacodyl tablets Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of a Same-day, Reduced Volume Polyethylene Glycol + Electrolyte Solution (PEG-ELS) Bowel Preparation for Afternoon Colonoscopies
Study Start Date : January 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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.
 Drug: polyethylene glycol (PEG-ELS) and bisacodyl tablets
2 liters of PEG-ELS and 10mg of bisacodyl tablets once the morning of the colonoscopy


Outcome Measures
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Primary Outcome Measures :
  1. Primary outcome: adequacy of bowel preparation. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044394


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Brian Jacobson, MD Boston Medicial Center Gastroenterology Department
More Information
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Responsible Party: Brian Jacobson, Associate professor of medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01044394    
Other Study ID Numbers: H-28808
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012
Keywords provided by Brian Jacobson, Boston Medical Center:
colonoscopy
bowel preparation
polyethylene glycol
Quality in endoscopy
Bowel Preparation for colonoscopy
Additional relevant MeSH terms:
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Bisacodyl
Cathartics
Gastrointestinal Agents
Laxatives