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Same-day, Reduced Volume Bowel Preparation

This study has been withdrawn prior to enrollment.
(A phase III RCT was published showing this approach is effective)
Sponsor:
Information provided by (Responsible Party):
Brian Jacobson, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01044394
First received: January 5, 2010
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Bowel Preparation
 Drug: polyethylene glycol (PEG-ELS) and bisacodyl tablets
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Primary outcome: adequacy of bowel preparation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044394

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Brian Jacobson, MD Boston Medicial Center Gastroenterology Department
  More Information

No publications provided

Responsible Party: Brian Jacobson, Associate professor of medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01044394     History of Changes
Other Study ID Numbers: H-28808
Study First Received: January 5, 2010
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
colonoscopy
bowel preparation
polyethylene glycol
Quality in endoscopy
Bowel Preparation for colonoscopy

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013