Comparison of Bowel Cleansing Methods for Colonoscopy in Hospitalized Patients

Intestine; Complaints Clinical Trial

— PEG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01528098
• Other study ID #: PEGPD
• Status: Not yet recruiting
• Phase: N/A
• First received: February 3, 2012
• Last updated: February 20, 2012
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2012
• Source: Kangbuk Samsung Hospital
• Contact: Dong Il Park, professor
• Phone: 82-2-2001-2059
• Email: diksmc.park[@]samsung.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intestine; Complaints

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital	Hanyang University, Kyunghee University, Soon Chun Hyang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of bowel preparation	Ottawa scale	one day (after colonoscopy)	No
Secondary	Patient's compliance and acceptability	acceptability, Visual Analogue Scale	one day (after injestion of preparation solution)	No
Secondary	Patient's compliance and acceptability (2)	stress for ingestion, Stress 0(not) - 4(severe)	one day (after injestion of preparation solution)	No
Secondary	Patient's compliance and acceptability (3)	willingness for re-evaluation, 0(very willing) - 4(some)	one day (after colonoscopy)	No