Second Bowel Preparation for Colonoscopy Failure

NCT01510977 | Terminated Phase 4

• 1 other identifier: 2009-0733
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy Failure; Poor Bowel Preparation

Keywords

colonoscopy; bowel preparation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

PEG

ACTIVE COMPARATOR

2L of polyethylene glycol addition immediately after first colonoscopy failure

Drug: polyethylene glycol

PEG + bisacodyl

EXPERIMENTAL

One week after initial colonoscopy failure, conventional amount (5L) of polyethylene glycol together with bisacodyl administration

Drug: polyethylene glycol, Bisacodyl

Interventions

polyethylene glycol, Bisacodyl DRUG

After failure of first colonoscopy, bowel preparation with polyethylene glycol and bisacodyl one week after

PEG + bisacodyl

polyethylene glycol DRUG

Immediately after first colonoscopy failure, polyethylene glycol 2L addition

PEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First colonoscopy failure due to inadequate bowel preparation

You may not qualify if:

• younger than 18 years old
• presence of inflammatory bowel disease
• pregnant
• lactating
• refusal

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

Polyethylene Glycols; Bisacodyl

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jeong-Sik Byeon, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 18, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

KR (1)