Second Bowel Preparation for Colonoscopy Failure

Phase 4

Terminated

• Conditions: Colonoscopy Failure; Poor Bowel Preparation
• Interventions: Drug: polyethylene glycol, Bisacodyl; Drug: polyethylene glycol

• Registration Number: NCT01510977
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG + bisacodyl	polyethylene glycol, Bisacodyl	One week after initial colonoscopy failure, conventional amount (5L) of polyethylene glycol together with bisacodyl administration
PEG	polyethylene glycol	2L of polyethylene glycol addition immediately after first colonoscopy failure

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of