Comparison of Bowel Cleansing Methods for Colonoscopy in Hospitalized Patients (PEG)

Efficacy of Bisacodyl Given as Part of a Polyethylene Glycol-based Bowel Preparation Prior to Colonoscopy in Hospitalized Patients

The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus bisacodyl versus PEG alone for bowel preparation in hospitalized patients.

Study Overview

• Status: Unknown
• Conditions: Intestine; Complaints

Detailed Description

Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated, especially in hospitalized patients who had comorbidity and restricted ambulation. Recently, a new PEG-based bowel cleansing agents became available. It combines PEG with a high dose of ascorbic acid or bisacodyl. Although many studies reported the efficacy of these combined solution for colonoscopy, but efficacy in hospitalized patients was under-recognized.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hospitalized patients for colonoscopy in university hospital.

Description

Inclusion Criteria:

• Hospitalized patients for colonoscopy

Exclusion Criteria:

• age under 20 years or over 80 years
• major psychiatric illness
• known allergy to PEG
• serious condition- severe cardiac, renal, or metabolic diseases
• partial colon resection
• current acute exacerbation of chronic inflammatory bowel disease
• functional constipation defined by Rome III diagnostic criteria

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PEG 4L; Those who taken PEG 4L alone
PEG plus bisacodyl; Those who taken PEG 4L + bisacodyl 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of bowel preparation	Ottawa scale	one day (after colonoscopy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's compliance and acceptability	acceptability, Visual Analogue Scale	one day (after injestion of preparation solution)
Patient's compliance and acceptability (2)	stress for ingestion, Stress 0(not) - 4(severe)	one day (after injestion of preparation solution)
Patient's compliance and acceptability (3)	willingness for re-evaluation, 0(very willing) - 4(some)	one day (after colonoscopy)

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Collaborators: Hanyang University; Soon Chun Hyang University; Kyunghee University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimate): February 7, 2012

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 20, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: polyethylene glycol; bisacodyl
• Other Study ID Numbers: PEGPD