Second Bowel Preparation for Colonoscopy Failure

NCT ID: NCT01510977

Last Updated: 2013-02-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

PEG

2L of polyethylene glycol addition immediately after first colonoscopy failure

Group Type: ACTIVE_COMPARATOR

polyethylene glycol

Intervention Type: DRUG

Immediately after first colonoscopy failure, polyethylene glycol 2L addition

PEG + bisacodyl

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

Group Type: EXPERIMENTAL

polyethylene glycol, Bisacodyl

Intervention Type: DRUG

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

Interventions

polyethylene glycol, Bisacodyl

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

Intervention Type: DRUG

polyethylene glycol

Immediately after first colonoscopy failure, polyethylene glycol 2L addition

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeong-Sik Byeon

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong-Sik Byeon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2009-0733

Identifier Type: -

Identifier Source: org_study_id