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
  Purpose

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 Intervention Phase
Colonoscopy Failure
Poor Bowel Preparation
Drug: polyethylene glycol, Bisacodyl
Drug: polyethylene glycol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: November 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jeong-Sik Byeon, Clinical Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01510977     History of Changes
Other Study ID Numbers: 2009-0733
Study First Received: January 9, 2012
Last Updated: February 11, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
colonoscopy
bowel preparation

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

ClinicalTrials.gov processed this record on October 19, 2014