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.

Study Overview

• Status: Terminated
• Conditions: Colonoscopy Failure; Poor Bowel Preparation
• Intervention / Treatment: Drug: polyethylene glycol; Drug: polyethylene glycol, Bisacodyl

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group)	one week
second colonoscopy failure due to inadequate bowel preparation (PEG group)	within the same day

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Jeong-Sik Byeon, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 18, 2012

Study Record Updates

• Last Update Posted (Estimate): February 13, 2013
• Last Update Submitted That Met QC Criteria: February 11, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl
• Other Study ID Numbers: 2009-0733