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Second Bowel Preparation for Colonoscopy Failure

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ClinicalTrials.gov Identifier: NCT01510977
Recruitment Status : Terminated
First Posted : January 18, 2012
Last Update Posted : February 13, 2013
Sponsor:
Information provided by (Responsible Party):
Jeong-Sik Byeon, Asan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colonoscopy Failure Poor Bowel Preparation Drug: polyethylene glycol, Bisacodyl Drug: polyethylene glycol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Outcome of a Second Preparation for Colonoscopy After Preparation Failure in the First Procedure: a Prospective Randomized Controlled Study
Study Start Date : November 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: PEG
2L of polyethylene glycol addition immediately after first colonoscopy failure
Drug: polyethylene glycol
Immediately after first colonoscopy failure, polyethylene glycol 2L addition
Experimental: PEG + bisacodyl
One week after initial colonoscopy failure, conventional amount (5L) of polyethylene glycol together with bisacodyl administration
Drug: polyethylene glycol, Bisacodyl
After failure of first colonoscopy, bowel preparation with polyethylene glycol and bisacodyl one week after



Primary Outcome Measures :
  1. second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group) [ Time Frame: one week ]
  2. second colonoscopy failure due to inadequate bowel preparation (PEG group) [ Time Frame: within the same day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01510977


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Jeong-Sik Byeon, MD, PhD Asan Medical Center

Responsible Party: Jeong-Sik Byeon, Clinical Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01510977     History of Changes
Other Study ID Numbers: 2009-0733
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by Jeong-Sik Byeon, Asan Medical Center:
colonoscopy
bowel preparation

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Laxatives