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This study has been withdrawn prior to enrollment.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

January 5, 2010
August 30, 2012
January 2010
June 2011   (final data collection date for primary outcome measure)
Primary outcome: adequacy of bowel preparation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01044394 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Same-day, Reduced Volume Bowel Preparation
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bowel Preparation
Drug: polyethylene glycol (PEG-ELS) and bisacodyl tablets
2 liters of PEG-ELS and 10mg of bisacodyl tablets once the morning of the colonoscopy
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.
Intervention: Drug: polyethylene glycol (PEG-ELS) and bisacodyl tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01044394
H-28808
Yes
Brian Jacobson, Boston Medical Center
Boston Medical Center
Not Provided
Principal Investigator: Brian Jacobson, MD Boston Medicial Center Gastroenterology Department
Boston Medical Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP