Second Bowel Preparation for Colonoscopy Failure

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Jeong-Sik Byeon, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01510977
First received: January 9, 2012
Last updated: February 11, 2013
Last verified: February 2013

January 9, 2012
February 11, 2013
November 2011
February 2013   (final data collection date for primary outcome measure)
  • second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group) [ Time Frame: one week ] [ Designated as safety issue: No ]
  • second colonoscopy failure due to inadequate bowel preparation (PEG group) [ Time Frame: within the same day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01510977 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Second Bowel Preparation for Colonoscopy Failure
The Outcome of a Second Preparation for Colonoscopy After Preparation Failure in the First Procedure: a Prospective Randomized Controlled Study

Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as well as inadequate diagnostic yield of colonic lesions. Frequency of colonoscopy failure due to bad bowel preparation is reported to be 0.3% to 6.5 percent, and the rate increases with liver cirrhosis, constipation, dementia, stroke, or administration of tricyclic antidepressants. In case of colonoscopy failure due to bad bowel preparation, the second colonoscopy can be performed with either adding a colon cleansing solution immediately, or it can be performed after a few days with colon cleansing agent together with prokinetics. These different kinds of bowel preparations after first colonoscopy failure have not been compared.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Colonoscopy Failure
  • Poor Bowel Preparation
  • Drug: polyethylene glycol, Bisacodyl
    After failure of first colonoscopy, bowel preparation with polyethylene glycol and bisacodyl one week after
  • Drug: polyethylene glycol
    Immediately after first colonoscopy failure, polyethylene glycol 2L addition
  • Active Comparator: PEG
    2L of polyethylene glycol addition immediately after first colonoscopy failure
    Intervention: Drug: polyethylene glycol
  • Experimental: PEG + bisacodyl
    One week after initial colonoscopy failure, conventional amount (5L) of polyethylene glycol together with bisacodyl administration
    Intervention: Drug: polyethylene glycol, Bisacodyl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • First colonoscopy failure due to inadequate bowel preparation

Exclusion Criteria:

  • younger than 18 years old
  • presence of inflammatory bowel disease
  • pregnant
  • lactating
  • refusal
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01510977
2009-0733
No
Jeong-Sik Byeon, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Jeong-Sik Byeon, MD, PhD Asan Medical Center
Asan Medical Center
February 2013

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