Comparison of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy

Colonoscopy [E01.370.372.250.250.200] Clinical Trial

Official title:

Randomized Controlled Trial of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01740518
• Other study ID #: ASCPD
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 30, 2012
• Last updated: November 30, 2012
• Start date: March 2012

Study information

• Verified date: November 2012
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• 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 low volume (2L) polyethylene glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in out-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. a new low volume PEG-based bowel cleansing agents became available at foreign countries. Although several studies reported the efficacy and improved compliance of these low volume PEG plus ascorbic acid solution for colonoscopy, but result in Korean patients was not-recognized.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 360
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Out-patients for colonoscopy

Exclusion Criteria:

• age under 19 years or over 80 years

• Intestinal obstruction

• Women of pregnant, breastfeeding, or at risk of becoming pregnant

• major psychiatric illness

• known allergy to PEG

• serious condition- severe cardiac, renal, or metabolic diseases

• past history of 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

• Colonoscopy [E01.370.372.250.250.200]

Intervention

Drug:
• polyethylene glycol, ascorbic acid
comparison of different solutions for bowel preparation

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong Il Park, M.D, Ph.D.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of bowel preparation	three segmental preparation scoring (0~4, Rt., mid, Lt.colon) total preparation grade:A,B,C,D (A or B was defined successful bowel cleansing) Influence of the intake of additional fluid in PEG+ascorbic acid	one day (after colonoscopy)	No
Secondary	Patient's compliance and acceptability	satisfaction (Visual Analogue Scale) amount of ingestion, frequency and amount of vomiting, tolerability, complication, taste	one day (after injestion of preparation solution)	No

External Links

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